Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-01-17 @ 2:21 AM
Study NCT ID:
NCT04459702
Status:
WITHDRAWN
Last Update Posted:
2021-04-08
First Post:
2020-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Combination Therapies to Treat COVID-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], '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': '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': 'D006886', 'term': 'Hydroxychloroquine'}, {'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D061466', 'term': 'Lopinavir'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Was never started', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2020-06-25', 'studyFirstSubmitQcDate': '2020-07-04', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores', 'timeFrame': '6 months', 'description': "Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk."}, {'measure': 'Efficacy of Treatment by Time to Non-Infectivity', 'timeFrame': '10 days', 'description': 'Time to non-infectivity as measured by PCR testing'}], 'secondaryOutcomes': [{'measure': 'Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores', 'timeFrame': '6 months', 'description': "Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk."}, {'measure': 'Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores.', 'timeFrame': '6 months', 'description': "Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk."}, {'measure': 'Safety of Dual Therapy as Measured by Complete Blood Count', 'timeFrame': '6 months', 'description': 'Changes in blood parameters measured in a Complete Blood Count (CBC).'}, {'measure': 'Safety of Quadruple Therapy as Measured by Complete Blood Count', 'timeFrame': '6 months', 'description': 'Changes in blood parameters measured in a Complete Metabolic Panel.'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel -Albumin', 'timeFrame': '6 months', 'description': 'Changes in serum albumin levels'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin', 'timeFrame': '6 months', 'description': 'Changes in serum albumin levels'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio', 'timeFrame': '6 months', 'description': 'Changes in serum albumin/globulin ratio'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio', 'timeFrame': '6 months', 'description': 'Changes in serum albumin/globulin ratio'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase', 'timeFrame': '6 months', 'description': 'Changes in serum alkaline phosphatase levels'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase', 'timeFrame': '6 months', 'description': 'Changes in serum alkaline phosphatase levels'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel - AST', 'timeFrame': '6 months', 'description': 'Changes in serum AST levels'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel - AST', 'timeFrame': '6 months', 'description': 'Changes in serum AST levels'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT', 'timeFrame': '6 months', 'description': 'Changes in serum ALT levels'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel ALT', 'timeFrame': '6 months', 'description': 'Changes in serum ALT levels'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio', 'timeFrame': '6 months', 'description': 'Changes in serum BUN/Creatinine Ratio'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio', 'timeFrame': '6 months', 'description': 'Changes in serum BUN/Creatinine Ratio'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN', 'timeFrame': '6 months', 'description': 'Changes in serum Blood Urea Nitrogen levels'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel - BUN', 'timeFrame': '6 months', 'description': 'Changes in serum Blood Urea Nitrogen levels'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel - Calcium', 'timeFrame': '6 months', 'description': 'Changes in serum calcium levels'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium', 'timeFrame': '6 months', 'description': 'Changes in serum calcium levels'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide', 'timeFrame': '6 months', 'description': 'Changes in serum carbon dioxide levels'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide', 'timeFrame': '6 months', 'description': 'Changes in serum carbon dioxide levels'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel - Chloride', 'timeFrame': '6 months', 'description': 'Changes in serum chloride levels'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride', 'timeFrame': '6 months', 'description': 'Changes in serum chloride levels'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine', 'timeFrame': '6 months', 'description': 'Changes in serum creatinine levels'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine', 'timeFrame': '6 months', 'description': 'Changes in serum creatinine levels'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel - Globulin', 'timeFrame': '6 months', 'description': 'Changes in serum globulin levels'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin', 'timeFrame': '6 months', 'description': 'Changes in serum globulin levels'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose', 'timeFrame': '6 months', 'description': 'Changes in blood glucose levels'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel - Glucose', 'timeFrame': '6 months', 'description': 'Changes in blood glucose levels'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel - Potassium', 'timeFrame': '6 months', 'description': 'Changes in blood potassium levels'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium', 'timeFrame': '6 months', 'description': 'Changes in blood potassium levels'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin', 'timeFrame': '6 months', 'description': 'Changes in serum total bilirubin levels'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin', 'timeFrame': '6 months', 'description': 'Changes in serum total bilirubin levels'}, {'measure': 'Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein', 'timeFrame': '6 months', 'description': 'Changes in serum total protein levels'}, {'measure': 'Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein', 'timeFrame': '6 months', 'description': 'Changes in serum total protein levels'}, {'measure': 'Safety of Dual Therapy as Measured by Treatment Related SAE', 'timeFrame': '6 months', 'description': 'Presence or absence of treatment related serious adverse events Grade III or higher'}, {'measure': 'Safety of Quadruple Therapy as Measured by Treatment Related SAE', 'timeFrame': '6 months', 'description': 'Presence or absence of treatment related serious adverse events Grade III or higher'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID', 'COVID-19', 'Corona Virus Infection', 'Coronavirus Infection', 'Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere', 'Coronavirus-19', 'SARS-CoV 2', 'SARS Pneumonia']}, 'descriptionModule': {'briefSummary': 'This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.', 'detailedDescription': 'In this study, patients will be administered either dual or quadruple therapy and have PCR tests run daily to determine efficacy as indicated by time to non-infectivity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study\n2. Healthy, ambulant male or female subjects 18 years of age to 65 years of age\n3. Positive test for COVID-19 by RT-PCR at screening\n4. Subjects must agree to practice at least one highly effective method of birth control for the duration of the study. This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized)\n5. Subjects must agree they will do their best to attend the treatment facility daily for 10 days\n\nExclusion Criteria:\n\n1. Refusal to sign informed consent form\n2. Negative test for COVID-19 by RT-PCR at screening\n3. Severe disease symptomatically including pneumonia, respiratory distress, tachypnea, shortness of breath, temperature \\> 38 degrees; pleuritic pain, or frequent cough.\n4. Known drug allergy to any of the investigational medications\n5. Currently taking medication with known drug interactions with investigational medications (listed in appendix)\n6. Prescription or other antiviral medications\n7. Any comorbidities which constitute health risk for the subject\n8. Pregnant or lactating females;\n9. weight \\< 110lb;\n10. porphyria\n11. established retinal disease\n12. Inability to attend daily for 10 days\n13. Any contraindications for treatment with hydroxychloroquine\n\n 1. Hypoglycemia\n 2. Known G6PD deficiency\n 3. Porphyria\n 4. Anemia\n 5. Neutropenia\n 6. Alcoholism\n 7. Myasthenia gravis\n 8. Skeletal muscle disorders\n 9. Maculopathy\n 10. Changes in visual field\n 11. Liver disease\n 12. Psoriasis\n 13. History of QT \\>500msec\n 14. History of torsades de pointes\n14. Anemia from pyruvate kinase and G6PD deficiencies\n15. Abnormal EKG with QT prolongation acquired or from birth\n16. History of jaundice or high fevers prior to developing COVID-19\n17. Treatment with any of the medications listed in Appendix II\n18. Treatment with any anti-epileptic medication\n19. Treatment with any other drug not listed that affects the QT interval'}, 'identificationModule': {'nctId': 'NCT04459702', 'briefTitle': 'A Study of Combination Therapies to Treat COVID-19 Infection', 'organization': {'class': 'OTHER', 'fullName': 'ProgenaBiome'}, 'officialTitle': 'A Phase IIa Randomized, Controlled Study of Combination Therapies to Treat COVID-19 Infection', 'orgStudyIdInfo': {'id': 'PRG-043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dual Therapy', 'description': 'Dual Therapy utilizing hydroxychloroquine and azithromycin.', 'interventionNames': ['Drug: hydroxychloroquine', 'Drug: Azithromycin']}, {'type': 'EXPERIMENTAL', 'label': 'Quadruple Therapy', 'description': 'Quadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin', 'interventionNames': ['Drug: hydroxychloroquine', 'Drug: Azithromycin', 'Drug: Ritonavir', 'Drug: Lopinavir']}], 'interventions': [{'name': 'hydroxychloroquine', 'type': 'DRUG', 'otherNames': ['Plaquenil'], 'description': 'Treatment with the drug hydroxychloroquine', 'armGroupLabels': ['Dual Therapy', 'Quadruple Therapy']}, {'name': 'Azithromycin', 'type': 'DRUG', 'otherNames': ['Zithromax'], 'description': 'Treatment with the drug azithromycin', 'armGroupLabels': ['Dual Therapy', 'Quadruple Therapy']}, {'name': 'Ritonavir', 'type': 'DRUG', 'otherNames': ['norvir'], 'description': 'Treatment with the drug ritonavir', 'armGroupLabels': ['Quadruple Therapy']}, {'name': 'Lopinavir', 'type': 'DRUG', 'description': 'Treatment with the drug lopinavir', 'armGroupLabels': ['Quadruple Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'ProgenaBiome', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}], 'overallOfficials': [{'name': 'Sabine Hazan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ProgenaBiome'}, {'name': 'Thomas Borody, MD, PhD,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Big Corona Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProgenaBiome', 'class': 'OTHER'}, 'collaborators': [{'name': 'Big Corona Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}