Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-30 @ 1:18 PM
Study NCT ID:
NCT05077969
Status:
TERMINATED
Last Update Posted:
2024-07-09
First Post:
2021-10-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients
Sponsor:
Organization:
Raw JSON
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As a result the study was halted prematurely.'}}, 'adverseEventsModule': {'timeFrame': '90 days', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1 (Study Product)', 'description': 'Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.\n\nFamotidine: 80 mg tablet, QID for 14 days\n\nCelecoxib: 400 mg (initial dose), then 200 mg capsule, BID for 5 days', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2 (Reference Therapy)', 'description': 'Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.\n\nPlacebo: tablet, QID for 14 days; capsule, BID for 5 days', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sinus Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With at Least One COVID-19-related Medically Attended Contact Due to Increased COVID-19 Symptom Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Study Product)', 'description': 'Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.\n\nFamotidine: 80 mg tablet, QID for 14 days\n\nCelecoxib: 400 mg (initial dose), then 200 mg capsule, BID for 5 days'}, {'id': 'OG001', 'title': 'Group 2 (Reference Therapy)', 'description': 'Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.\n\nPlacebo: tablet, QID for 14 days; capsule, BID for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 30', 'description': 'Medically attended contact will be measured in whole numbers and reported as "1 medically attended contact" each time, in the electronic data capture system for all study participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Patients With at Least One COVID-19-related Medically Attended Contact Due to Death (All-cause Mortality).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Study Product)', 'description': 'Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.\n\nFamotidine: 80 mg tablet, QID for 14 days\n\nCelecoxib: 400 mg (initial dose), then 200 mg capsule, BID for 5 days'}, {'id': 'OG001', 'title': 'Group 2 (Reference Therapy)', 'description': 'Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.\n\nPlacebo: tablet, QID for 14 days; capsule, BID for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 30', 'description': 'Medically attended contact will be measured in whole numbers and reported as "1 medically attended contact" in the electronic data capture system for all study participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were all white (non-Hispanic) females between 18 and 65 years of age.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Serious Adverse Events (SAE) as Assessed by Participant Withdrawal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Study Product)', 'description': 'Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.\n\nFamotidine: 80 mg tablet, QID for 14 days\n\nCelecoxib: 400 mg (initial dose), then 200 mg capsule, BID for 5 days'}, {'id': 'OG001', 'title': 'Group 2 (Reference Therapy)', 'description': 'Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.\n\nPlacebo: tablet, QID for 14 days; capsule, BID for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'Study discontinuation will be measured in whole units, by number of participants who are removed with the reason of "SAE" and captured by the electronic data capture system.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were all white (non-Hispanic) females between 18 and 65 years of age.'}, {'type': 'SECONDARY', 'title': 'Incidence of Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (Study Product)', 'description': 'Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.\n\nFamotidine: 80 mg tablet, QID for 14 days\n\nCelecoxib: 400 mg (initial dose), then 200 mg capsule, BID for 5 days'}, {'id': 'OG001', 'title': 'Group 2 (Reference Therapy)', 'description': 'Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.\n\nPlacebo: tablet, QID for 14 days; capsule, BID for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Deaths will be captured by whole numbers, by number of participants who are removed from the study with reason as "death" in the electronic data capture system.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were all white (non-Hispanic) females between 18 and 65 years of age.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 (Study Product)', 'description': 'Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.\n\nFamotidine: 80 mg tablet, QID for 14 days\n\nCelecoxib: 400 mg (initial dose), then 200 mg capsule, BID for 5 days'}, {'id': 'FG001', 'title': 'Group 2 (Reference Therapy)', 'description': 'Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.\n\nPlacebo: tablet, QID for 14 days; capsule, BID for 5 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'While 9 patients were randomized into the study only 4 patients received study drug due to early termination of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 (Study Product)', 'description': 'Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.\n\nFamotidine: 80 mg tablet, QID for 14 days\n\nCelecoxib: 400 mg (initial dose), then 200 mg capsule, BID for 5 days'}, {'id': 'BG001', 'title': 'Group 2 (Reference Therapy)', 'description': 'Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.\n\nPlacebo: tablet, QID for 14 days; capsule, BID for 5 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '45'}, {'value': '27', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '28'}, {'value': '34.75', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '45'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', '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 (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2022-04-11', 'size': 610671, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-10T13:30', 'hasProtocol': True}, {'date': '2022-07-07', 'size': 633030, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-10T13:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants randomized 1:1, study drug:placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Low recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2021-10-07', 'resultsFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2021-10-12', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-03', 'studyFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With at Least One COVID-19-related Medically Attended Contact Due to Increased COVID-19 Symptom Severity', 'timeFrame': 'Through Day 30', 'description': 'Medically attended contact will be measured in whole numbers and reported as "1 medically attended contact" each time, in the electronic data capture system for all study participants.'}, {'measure': 'Number of Patients With at Least One COVID-19-related Medically Attended Contact Due to Death (All-cause Mortality).', 'timeFrame': 'Through Day 30', 'description': 'Medically attended contact will be measured in whole numbers and reported as "1 medically attended contact" in the electronic data capture system for all study participants.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Serious Adverse Events (SAE) as Assessed by Participant Withdrawal', 'timeFrame': '90 days', 'description': 'Study discontinuation will be measured in whole units, by number of participants who are removed with the reason of "SAE" and captured by the electronic data capture system.'}, {'measure': 'Incidence of Death', 'timeFrame': '90 days', 'description': 'Deaths will be captured by whole numbers, by number of participants who are removed from the study with reason as "death" in the electronic data capture system.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'COVID', 'COVID19', 'SARS-CoV-2'], 'conditions': ['2019 Novel Coronavirus Disease', '2019 Novel Coronavirus Infection', '2019-nCoV Disease', '2019-nCoV Infection', 'COVID-19', 'COVID-19 Pandemic', 'COVID-19 Virus Disease', 'COVID-19 Virus Infection', 'Covid19', 'Coronavirus Disease 2019', 'SARS-CoV2 Infection', 'SARS-CoV-2 Acute Respiratory Disease']}, 'descriptionModule': {'briefSummary': 'This study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib. Each of these agents separately demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and each of which appear to have separate and complementary mechanisms of action.', 'detailedDescription': 'Qualifying patients will have been confirmed positive for COVID-19 and have symptoms of World Health Organization (WHO) Ordinal Scale for Clinical Improvement with scores of ≤3 on the 11-point scale and will be randomly assigned, in a 1:1 ratio, to one of two regimens, with 659 participants per group, as follows:\n\nGroup 1 (study product) participants will receive 80 mg famotidine by mouth (PO) 4 times per day (QID) + 400 mg celecoxib as a first dose, followed by 200 mg celecoxib (PO) 2 times per day (BID), for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.\n\nGroup 2 (reference therapy) participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.\n\nSafety and efficacy of famotidine and celecoxib will be evaluated.\n\nThis is a completely virtual trial and you can participate from your own home. Please call 1-888-370-9330 to speak to someone regarding study participation in your area.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female participants must be at least 18 years of age, inclusive, at the time of signing the informed consent form.\n* Confirmed SARS-CoV-2 polymerase chain reaction (PCR) positive patient within 5 days of enrollment, as shown by medical history and reported PCR test result.\n* Reports having one or more symptoms consistent with SARS-CoV-2, as defined in Master Protocol Appendix 3 Table 4.\n* COVID-19 diagnosis must be WHO grade ≤3.\n* Contraceptive use by men or women should be consistent with Appendix 4 of the Master protocol (LDOS-21-001).\n* Reliable access to the Internet via a browser installed on personal device or computer.\n* Capable of understanding and providing signed informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Ongoing antiviral or antiretroviral treatment\n* Known history of HIV\n* Ongoing anti-inflammatory treatment that cannot be temporarily discontinued during the study. This includes nonsteroidal anti-inflammatory drugs (NSAIDs), and corticosteroids - including Dexamethasone (dexamethasone administration restricted to recommended standard of care use per NIH COVID-19 Guidelines)\n\n 1. drugs dependent on gastric pH for absorption, e.g., dasatinib, delavirdine, mesylate, cefditoren, and fosamprenavir;\n 2. tizanidine (CYP1A2) substrate;\n 3. drugs that interfere with hemostasis (e.g., warfarin, aspirin, selective serotonin reuptake inhibitors \\[SSRIs\\]/serotonin norepinephrine reuptake inhibitors (SNRIs\\]);\n 4. angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), or beta-blockers;\n 5. diuretics;\n 6. digoxin\n* Ongoing treatment that cannot be temporarily discontinued during the study, with: antimalarials, antiarrhythmics, tricyclic antidepressants, natalizumab, quinolones, macrolides, agalsidase alfa and beta\n* Ongoing famotidine or celecoxib or other COVID-19 clinical investigational treatment(s) within the past 30 days, or current participation in another investigational clinical trial\n* History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs\n* History of immunosuppression\n* Rejection of participation by Principal Investigator or Sponsor\n* Any contraindication for famotidine or celecoxib treatment:\n\n 1. Famotidine or celecoxib hypersensitivity\n 2. Retinopathy, visual field or visual acuity disturbances\n 3. History of cardiovascular disease, such as congestive heart failure, QT prolongation, myocardial infarction, bradycardia (\\<50 bpm), ventricular tachycardia, other arrhythmias\n 4. Myasthenia gravis\n 5. Psoriasis or porphyria\n 6. History of renal failure/dialysis or a glomerular clearance \\<60 mL/min\n 7. History of severe hypoglycemia\n 8. Moderate or severe hepatic impairment, e.g., Child-Pugh Class B or C\n 9. Known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history or experience with other CYP2C9 substrates, such as warfarin and phenytoin'}, 'identificationModule': {'nctId': 'NCT05077969', 'briefTitle': 'Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Leidos Life Sciences'}, 'officialTitle': 'A Virtual Phase 2 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of the Combination of Famotidine and Celecoxib as a Post-exposure Prophylaxis (PEP) for Newly-infected COVID-19 Patients', 'orgStudyIdInfo': {'id': 'LDOS-21-001-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (Study Product)', 'description': 'Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.', 'interventionNames': ['Drug: Famotidine', 'Drug: Celecoxib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2 (Reference Therapy)', 'description': 'Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Famotidine', 'type': 'DRUG', 'otherNames': ['Pepcid'], 'description': '80 mg tablet, QID for 14 days', 'armGroupLabels': ['Group 1 (Study Product)']}, {'name': 'Celecoxib', 'type': 'DRUG', 'otherNames': ['Celebrex'], 'description': '400 mg (initial dose), then 200 mg capsule, BID for 5 days', 'armGroupLabels': ['Group 1 (Study Product)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'tablet, QID for 14 days; capsule, BID for 5 days', 'armGroupLabels': ['Group 2 (Reference Therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92603', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Integrated Therapeutic Solutions USA, Inc.', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Integrated Therapeutic Solutions USA, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30363', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Integrated Health Solutions USA, Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31539', 'city': 'Hazlehurst', 'state': 'Georgia', 'country': 'United States', 'facility': 'Integrated Therapeutic Solutions USA, Inc', 'geoPoint': {'lat': 31.86963, 'lon': -82.5943}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Integrated Therapeutic Solutions USA, Inc.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40059', 'city': 'Prospect', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Integrated Therapeutic Solutions USA, Inc', 'geoPoint': {'lat': 38.34507, 'lon': -85.61552}}, {'zip': '21702', 'city': 'Frederick', 'state': 'Maryland', 'country': 'United States', 'facility': 'Integrated Therapeutic Solutions USA, Inc', 'geoPoint': {'lat': 39.41427, 'lon': -77.41054}}, {'zip': '20878', 'city': 'Gaithersburg', 'state': 'Maryland', 'country': 'United States', 'facility': 'Integrated Therapeutic Solutions USA, Inc', 'geoPoint': {'lat': 39.14344, 'lon': -77.20137}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Integrated Therapeutic Solutions USA, Inc', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '48120', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': 'Integrated Therapeutic Solutions USA, Inc', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '07102', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Integrated Therapeutic Solutions USA, Inc.', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10005', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Integrated Therapeutic Solutions USA, Inc.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '16652', 'city': 'Huntingdon', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Integrated Therapeutic Solutions USA, Inc.', 'geoPoint': {'lat': 40.4848, 'lon': -78.01028}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Integrated Therapeutic Solutions USA, Inc.', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75219', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Integrated Therapeutic Solutions USA, Inc.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Brian A Roberts, MS, PMP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Leidos, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It is not yet known if there will be a plan to make individual participant data (IPD) available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leidos Life Sciences', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}