Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT04346667
Status:
TERMINATED
Last Update Posted:
2021-03-10
First Post:
2020-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D058070', 'term': 'Asymptomatic Diseases'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002738', 'term': 'Chloroquine'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'whyStopped': 'Poor accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2020-04-13', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RT-PCR negative status', 'timeFrame': '6-7 days', 'description': 'Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7'}], 'secondaryOutcomes': [{'measure': 'Progression of symptoms', 'timeFrame': '7 days', 'description': 'Time to progression to next stage of SARS-CoV-2 disease severity index'}, {'measure': 'Development of Symptoms', 'timeFrame': '7 days', 'description': 'Time to onset of fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate \\>22 per minute).'}, {'measure': 'Adverse events', 'timeFrame': '7 days', 'description': 'Drug related adverse events as determined by data safety and monitoring board (DSMB)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV-2', 'Coronavirus Infection', 'Asymptomatic Condition', 'COVID-19']}, 'descriptionModule': {'briefSummary': 'To create a protocol for treatment of Pakistani patients with SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different quinone drug dosing regimens in controlling SARS-CoV-2 infection for asymptomatic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Nasopharyngeal RT-PCR positive SARS-CoV-2 patient\n2. Age 20-50 years\n3. BMI 18-28 kg/m2\n4. Informed consent\n\nExclusion Criteria:\n\n1. Symptoms: Cough, fever, shortness of breath\n2. O2 saturation by pulse-oximeter below 94%\n3. Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes\n4. Arrhythmias and/or history of arrythmia\n5. Psoriasis and/or history of psoriasis\n6. Neuropathy or myopathy and/or history of these\n7. Hypoglycemia and/or history of hypoglycemia\n8. Pre-existing hepatic disease\n9. Pre-existing renal disease\n10. Use of antacids within 1 week\n11. Use of antibiotics within 1 week\n12. Pregnancy\n13. RT-PCR performed \\>3 days prior to enrollment'}, 'identificationModule': {'nctId': 'NCT04346667', 'acronym': 'PEACE', 'briefTitle': 'Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Government of Punjab, Specialized Healthcare and Medical Education Department'}, 'officialTitle': 'Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Real Time Polymerase Chain Reaction (RT-PCR) Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate', 'orgStudyIdInfo': {'id': 'NBC-COVID19-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care', 'interventionNames': ['Drug: Hydroxychloroquine Sulfate Regular dose']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care', 'interventionNames': ['Drug: Hydroxychloroquine Sulfate Loading Dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3', 'description': 'Chloroquine 500 mg BID for 5 days plus standard of care', 'interventionNames': ['Drug: Chloroquine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 4', 'description': 'Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Hydroxychloroquine Sulfate Regular dose', 'type': 'DRUG', 'description': 'Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2', 'armGroupLabels': ['Arm 1']}, {'name': 'Hydroxychloroquine Sulfate Loading Dose', 'type': 'DRUG', 'description': 'Hydroxychloroquine administered as a loading dose only', 'armGroupLabels': ['Arm 2']}, {'name': 'Chloroquine', 'type': 'DRUG', 'description': 'Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2', 'armGroupLabels': ['Arm 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Standard of Care plus placebo', 'armGroupLabels': ['Arm 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Expo Covid Center', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Mayo Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Pakistan Kidney and Liver Institute', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Government of Punjab, Specialized Healthcare and Medical Education Department', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Mayo Hospital Lahore', 'class': 'OTHER'}, {'name': 'Services Institute of Medical Sciences, Pakistan', 'class': 'OTHER_GOV'}, {'name': 'Pakistan Kidney and Liver Institute', 'class': 'UNKNOWN'}, {'name': 'Forman Christian College, Pakistan', 'class': 'OTHER'}, {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Radiology', 'investigatorFullName': 'Ammar Sarwar', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}