Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-30 @ 2:41 PM
Study NCT ID:
NCT05736861
Status:
COMPLETED
Last Update Posted:
2023-06-13
First Post:
2023-02-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm A (Ivermectin 400)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007559', 'term': 'Ivermectin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'susanna.naggie@duke.edu', 'phone': '919-684-2584', 'title': 'Susanna Naggie, MD, MHS, FIDSA', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 90 days', 'description': 'Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90.\n\nAdverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.', 'otherNumAtRisk': 817, 'deathsNumAtRisk': 817, 'otherNumAffected': 16, 'seriousNumAtRisk': 817, 'deathsNumAffected': 1, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.', 'otherNumAtRisk': 774, 'deathsNumAtRisk': 774, 'otherNumAffected': 13, 'seriousNumAtRisk': 774, 'deathsNumAffected': 0, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Accelerated hair loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood pressure raised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hair loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Interstitial pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Migraine with aura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea and emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Seasonal Allergies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Shoulder dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Suspected Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'COVID-19 pneumonia aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bacteremia, with signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia due to Staphylococcus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia due to Streptococcus, group b', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Venous thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary vasospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'COVID-19 pneumonia worsening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Death due to COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Opthalmic migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia due to COVID-19 virus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper GI bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Worsening of covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 817, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 774, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Sustained Recovery in Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '14'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.17', 'estimateComment': 'The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Decision rule based on Bayesian posterior probability of efficacy. The decision threshold was a posterior probability of 0.95. A prespecified skeptical prior for the treatment effect was used to preserve type I error below 0.05.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 days', 'description': 'Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hospitalization or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.4', 'ciUpperLimit': '2.6', 'estimateComment': 'The interval is a highest-density credible interval. Descriptive analysis is a maximum partial likelihood proportional hazards regression model. Low event rate precluded covariate adjustment.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Per the protocol/SAP, this endpoint is only analyzed if the number of total events exceeds 30. Due to the low event rate, the statistical analysis was not completed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Per the protocol/SAP, this endpoint is only analyzed if the number of total events exceeds 30. Due to the low event rate, the statistical analysis was not completed.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 28 days', 'description': 'Time to mortality was the number of days between drug receipt and death.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.6', 'ciUpperLimit': '1.8', 'estimateComment': 'The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Statistical analysis was a Bayesian proportional hazards regression model with covariate adjustment and weakly informative priors.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '813', 'groupId': 'OG000'}, {'value': '769', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'categories': [{'title': '0 = No clinical or virological evidence of infection', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'title': '1 = No limitation of activities', 'measurements': [{'value': '708', 'groupId': 'OG000'}, {'value': '646', 'groupId': 'OG001'}]}, {'title': '2 = Limitation of activities', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}, {'title': '3 = Hospitalized, no oxygen therapy', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '4 = Hospitalized, on oxygen by mask or nasal prongs', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '5 = Hospitalized, on non-invasive ventilation or high-flow oxygen', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '6 = Hospitalized, on intubation and mechanical ventilation', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '8 = Death', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.13', 'estimateComment': 'The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7', 'description': 'COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected on 9 participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '805', 'groupId': 'OG000'}, {'value': '765', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'categories': [{'title': '0 = No clinical or virological evidence of infection', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'title': '1 = No limitation of activities', 'measurements': [{'value': '722', 'groupId': 'OG000'}, {'value': '664', 'groupId': 'OG001'}]}, {'title': '2 = Limitation of activities', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': '3 = Hospitalized, no oxygen therapy', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '4 = Hospitalized, on oxygen by mask or nasal prongs', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '5 = Hospitalized, on non-invasive ventilation or high-flow oxygen', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '6 = Hospitalized, on intubation and mechanical ventilation', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '8 = Death', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.39', 'ciUpperLimit': '1.13', 'estimateComment': 'The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': 'COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected on 21 participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '795', 'groupId': 'OG000'}, {'value': '760', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'categories': [{'title': '0 = No clinical or virological evidence of infection', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}, {'title': '1 = No limitation of activities', 'measurements': [{'value': '718', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}, {'title': '2 = Limitation of activities', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': '3 = Hospitalized, no oxygen therapy', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '4 = Hospitalized, on oxygen by mask or nasal prongs', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '5 = Hospitalized, on non-invasive ventilation or high-flow oxygen', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '6 = Hospitalized, on intubation and mechanical ventilation', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '8 = Death', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.91', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28', 'description': 'COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected on 36 participants.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '763', 'groupId': 'OG000'}, {'value': '715', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '20'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '20'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '753', 'groupId': 'OG000'}, {'value': '707', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '20'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '20'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '685', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '20'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.25', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 7', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.23', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 14', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.41', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 28', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.01', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 90', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 7, 14, 28, and 90', 'description': 'The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for physical function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who responded to the quality of life survey at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '764', 'groupId': 'OG000'}, {'value': '715', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '13'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '13'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '707', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '9'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '9'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '8'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '685', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.32', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 7', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.22', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 14', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.24', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 28', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.10', 'groupDescription': 'Day 90', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 7, 14, 28, and 90', 'description': 'The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for fatigue.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who responded to the quality of life survey at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QOL) as Measured by the PROMIS-29 - Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '764', 'groupId': 'OG000'}, {'value': '715', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '9'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '8'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '751', 'groupId': 'OG000'}, {'value': '706', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '7'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '7'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '4'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '685', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.20', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 7', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.25', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 14', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.43', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 28', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.12', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 90', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 7, 14, 28, and 90', 'description': 'The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who responded to the quality of life survey at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QOL) as Measured by the PROMIS-29 - Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '764', 'groupId': 'OG000'}, {'value': '715', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '6'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '706', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '713', 'groupId': 'OG000'}, {'value': '685', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.35', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 7', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.57', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 14', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.54', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 28', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.18', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 90', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 7, 14, 28, and 90', 'description': 'The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who responded to the quality of life survey at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '764', 'groupId': 'OG000'}, {'value': '714', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '8'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '706', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '6'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '713', 'groupId': 'OG000'}, {'value': '685', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.47', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 7', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.33', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 14', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.55', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 28', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.19', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 90', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 7, 14, 28, and 90', 'description': 'The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who responded to the quality of life survey at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QOL) as Measured by the PROMIS-29 - Social', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '764', 'groupId': 'OG000'}, {'value': '715', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '20'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '20'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '705', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '20'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '20'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '684', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '17.25', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '20'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.26', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 7', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.29', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 14', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.34', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 28', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.28', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 90', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 7, 14, 28, and 90', 'description': 'The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a higher score correlates to better outcome for social roles and activities.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who responded to the quality of life survey at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '764', 'groupId': 'OG000'}, {'value': '715', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '12'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '12'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '705', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '12'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '11'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '11'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '11'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '685', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '11'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '11'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.27', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 7', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.14', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 14', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.09', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 28', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.36', 'estimateComment': 'Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.', 'groupDescription': 'Day 90', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 7, 14, 28, and 90', 'description': 'The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for sleep.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who responded to the quality of life survey at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Time Unwell in Days as Measured by the Symptom and Clinical Event Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.96', 'groupId': 'OG000', 'lowerLimit': '10.78', 'upperLimit': '11.15'}, {'value': '11.45', 'groupId': 'OG001', 'lowerLimit': '11.28', 'upperLimit': '11.60'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in model estimate time unwell', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '-0.15', 'estimateComment': 'The interval is a highest-density credible interval.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 days', 'description': 'The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). Time unwell was the portion of follow-up (in days) that a participant was symptomatic, hospitalized, or deceased. The quantity is estimated from a Bayesian longitudinal ordinal regression model with covariate adjustment and weakly informative priors.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Days Benefit as Measured by the Symptom and Clinical Event Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'OG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.91', 'groupId': 'OG000', 'lowerLimit': '3.69', 'upperLimit': '4.13'}, {'value': '3.31', 'groupId': 'OG001', 'lowerLimit': '3.11', 'upperLimit': '3.51'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in model estimated means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.18', 'ciUpperLimit': '0.99', 'estimateComment': 'The interval is a highest-density credible interval.', 'groupDescription': 'Analysis is exploratory. No hypothesis test or decision rule was evaluated.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 days', 'description': 'The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'FG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '919'}, {'groupId': 'FG001', 'numSubjects': '881'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '817'}, {'groupId': 'FG001', 'numSubjects': '774'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '107'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'BG000'}, {'value': '774', 'groupId': 'BG001'}, {'value': '1591', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.\n\nIvermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.'}, {'id': 'BG001', 'title': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '56'}, {'value': '48', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '56'}, {'value': '47', 'groupId': 'BG002', 'lowerLimit': '39', 'upperLimit': '56'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex/Gender', 'categories': [{'title': 'Female', 'measurements': [{'value': '508', 'groupId': 'BG000'}, {'value': '424', 'groupId': 'BG001'}, {'value': '932', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '309', 'groupId': 'BG000'}, {'value': '349', 'groupId': 'BG001'}, {'value': '658', 'groupId': 'BG002'}]}, {'title': 'Prefer Not to Answer', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '724', 'groupId': 'BG000'}, {'value': '704', 'groupId': 'BG001'}, {'value': '1428', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Black, African American, or African', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}, {'title': 'Middle Eastern or North African', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '643', 'groupId': 'BG000'}, {'value': '619', 'groupId': 'BG001'}, {'value': '1262', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'None of the above', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Prefer not to answer', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'No response', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '817', 'groupId': 'BG000'}, {'value': '774', 'groupId': 'BG001'}, {'value': '1591', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who completed the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-25', 'size': 2160593, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-10T11:34', 'hasProtocol': True}, {'date': '2021-07-22', 'size': 431499, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-03-10T11:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The participant and study teams will know which study drug the participant is allocated to, but will be blinded to study drug versus placebo because they will be matching.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-Blind, Placebo-Controlled, Randomized Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-16', 'studyFirstSubmitDate': '2023-02-17', 'resultsFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-02-17', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-15', 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Sustained Recovery in Days', 'timeFrame': 'Up to 28 days', 'description': 'Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Hospitalization or Death', 'timeFrame': 'Up to 28 days'}, {'measure': 'Number of Participants With Mortality', 'timeFrame': 'Up to 28 days'}, {'measure': 'Time to Mortality', 'timeFrame': 'Up to 28 days', 'description': 'Time to mortality was the number of days between drug receipt and death.'}, {'measure': 'Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death', 'timeFrame': 'Up to 28 days'}, {'measure': 'Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7', 'timeFrame': 'Day 7', 'description': 'COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.'}, {'measure': 'Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14', 'timeFrame': 'Day 14', 'description': 'COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.'}, {'measure': 'Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28', 'timeFrame': 'Day 28', 'description': 'COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.'}, {'measure': 'Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function', 'timeFrame': 'Day 7, 14, 28, and 90', 'description': 'The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for physical function.'}, {'measure': 'Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue', 'timeFrame': 'Day 7, 14, 28, and 90', 'description': 'The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for fatigue.'}, {'measure': 'Quality of Life (QOL) as Measured by the PROMIS-29 - Pain', 'timeFrame': 'Day 7, 14, 28, and 90', 'description': 'The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for pain.'}, {'measure': 'Quality of Life (QOL) as Measured by the PROMIS-29 - Depression', 'timeFrame': 'Day 7, 14, 28, and 90', 'description': 'The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for depression.'}, {'measure': 'Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety', 'timeFrame': 'Day 7, 14, 28, and 90', 'description': 'The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for anxiety.'}, {'measure': 'Quality of Life (QOL) as Measured by the PROMIS-29 - Social', 'timeFrame': 'Day 7, 14, 28, and 90', 'description': 'The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a higher score correlates to better outcome for social roles and activities.'}, {'measure': 'Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep Domain', 'timeFrame': 'Day 7, 14, 28, and 90', 'description': 'The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for sleep.'}, {'measure': 'Time Unwell in Days as Measured by the Symptom and Clinical Event Scale', 'timeFrame': 'Up to 14 days', 'description': 'The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). Time unwell was the portion of follow-up (in days) that a participant was symptomatic, hospitalized, or deceased. The quantity is estimated from a Bayesian longitudinal ordinal regression model with covariate adjustment and weakly informative priors.'}, {'measure': 'Mean Days Benefit as Measured by the Symptom and Clinical Event Scale', 'timeFrame': 'Up to 14 days', 'description': 'The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'COVID-19', 'ivermectin', 'Placebo', 'Duke University Health System', 'Outcomes', 'Duke Clinical Research Institute', 'ACTIV 6', 'ACTIV'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. They will self-report any new or worsening symptoms or medical events they may experience while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to see them in person.\n\nPrior and current drug arms are listed on clinicaltrials.gov and will be updated with the activation of any new drug arms. This protocol was originally registered under NCT04885530. Per recent guidance on reporting master protocol research programs (MPRPs), a separate record for Arm A was created.', 'detailedDescription': 'Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respect to the number of cases and overall mortality. The clinical disease related to SARS-CoV-2 is referred to as Coronavirus Disease 2019 (COVID-19). Over 2020, advances were made for treatment of COVID-19 and several vaccinations have received emergency use authorization for prevention of SARS-CoV-2 infections. However, the pandemic continues to evolve with new variants and surges of infections in different regions of the world, requiring an ongoing evidence-generating platform, in particular for the treatment of COVID-19 infection in the outpatient setting.\n\nThis proposed platform protocol can serve as an evidence generating system for prioritized drugs repurposed from other indications with an established safety record and preliminary evidence of clinical efficacy for the treatment of COVID-19. The ultimate goal is to evaluate if repurposed medications can make participants feel better faster and reduce death and hospitalization.\n\nThis platform protocol is designed to be flexible so that it is suitable for a wide range of settings within healthcare systems and in community settings where it can be integrated into routine COVID-19 testing programs and subsequent treatment plans. This platform protocol will enroll participants in an outpatient setting with a confirmed polymerase chain reaction (PCR) or antigen test for SARS-CoV-2.\n\nParticipants will be randomized to study drugs or placebo based on the arms that are actively enrolling at the time of randomization. Study drugs may be added or removed according to adaptive design and/or emerging evidence. When there are multiple study drugs available, randomization will occur based on appropriateness of each drug for the participant as determined by the study protocol and investigator and participant equipoise. Each participant will be required to randomize to at least one study drug versus placebo. The probability of placebo to treatment will remain the same regardless of eligibility decisions.\n\nEligible participants will be randomized (1:1), in a blinded fashion, to either the study drug arm or placebo arm in addition to standard of care. As additional study drugs are added, the randomization will be altered to leverage placebo data across arms. Participants will receive a complete supply study drug or placebo with the quantity depending on the study drug/placebo to which they are randomized.\n\nAll study visits are designed to be remote. However, screening and enrollment may occur in-person at sites and unplanned study visits may occur in-person or remotely, as deemed appropriate by the site investigator for safety purposes. Participants will be asked to complete questionnaires and report safety events during the study. Participants will be prompted by the online system to report safety events and these will be reviewed and confirmed via medical records and site staff, as necessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed Informed Consent\n* Age ≥ 30 years old\n* Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening\n* Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell\n\nExclusion Criteria:\n\n* Prior diagnosis of COVID-19 infection (\\> 10 days from screening)\n* Current or recent (within 10 days of screening) hospitalization\n* Current use of study drug or study drug/device combination\\*\n* Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo\\*\n* Known contraindication(s) to study drug including prohibited concomitant medications\\*\n\n\\[If only one study drug appendix is open at the time of enrollment. If multiple study drug appendices are open, a participant may opt-out of any study drug appendix or be excluded from any study drug appendix based on contraindications listed in the study drug appendix, current use of study drug, or known allergy/sensitivity/hypersensitivity and still remain eligible for the remaining study drug appendices.\\]\n\nArm-specific exclusion criteria:\n\n* End-stage renal disease on renal replacement therapy\n* Liver failure or decompensated cirrhosis\n* Use of warfarin, CYP3A4, P-gp inhibitor drugs, or CYP3A4 substrates\n* Nursing mothers\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05736861', 'briefTitle': 'ACTIV-6: COVID-19 Study of Repurposed Medications - Arm A (Ivermectin 400)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications', 'orgStudyIdInfo': {'id': 'Pro00107921_A'}, 'secondaryIdInfos': [{'id': '3U24TR001608-05W1', 'link': 'https://reporter.nih.gov/quickSearch/3U24TR001608-05W1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A - Ivermectin 400', 'description': 'Ivermectin - 7-mg tablets\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.', 'interventionNames': ['Drug: Ivermectin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm A - Placebo', 'description': 'Placebo - appearance and size matched to active study drug.\n\nParticipant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Ivermectin', 'type': 'DRUG', 'otherNames': ['Ivermectin Tablets'], 'description': 'Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.', 'armGroupLabels': ['Arm A - Ivermectin 400']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. 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Access will only be shared with those who have obtained prior IRB approval to be able to access this data.', 'accessCriteria': 'Interested investigators will need to seek prior IRB approval before access to any data is granted.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Susanna Naggie, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}, {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Susanna Naggie, MD', 'investigatorAffiliation': 'Duke University'}}}}