Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds (PEACE)
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ClinicalTrials.gov Identifier: NCT04346667 |
Recruitment Status :
Terminated
(Poor accrual.)
First Posted : April 15, 2020
Last Update Posted : March 10, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
SARS-CoV-2 Coronavirus Infection Asymptomatic Condition COVID-19 | Drug: Hydroxychloroquine Sulfate Regular dose Drug: Hydroxychloroquine Sulfate Loading Dose Drug: Chloroquine Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 125 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | April 14, 2020 |
Actual Primary Completion Date : | August 23, 2020 |
Actual Study Completion Date : | August 30, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Arm 1
Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care
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Drug: Hydroxychloroquine Sulfate Regular dose
Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2 |
Experimental: Arm 2
Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care
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Drug: Hydroxychloroquine Sulfate Loading Dose
Hydroxychloroquine administered as a loading dose only |
Active Comparator: Arm 3
Chloroquine 500 mg BID for 5 days plus standard of care
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Drug: Chloroquine
Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2 |
Placebo Comparator: Arm 4
Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)
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Drug: Placebo
Standard of Care plus placebo |
- RT-PCR negative status [ Time Frame: 6-7 days ]Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7
- Progression of symptoms [ Time Frame: 7 days ]Time to progression to next stage of SARS-CoV-2 disease severity index
- Development of Symptoms [ Time Frame: 7 days ]Time to onset of fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).
- Adverse events [ Time Frame: 7 days ]Drug related adverse events as determined by data safety and monitoring board (DSMB)

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Ages Eligible for Study: | 20 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Nasopharyngeal RT-PCR positive SARS-CoV-2 patient
- Age 20-50 years
- BMI 18-28 kg/m2
- Informed consent
Exclusion Criteria:
- Symptoms: Cough, fever, shortness of breath
- O2 saturation by pulse-oximeter below 94%
- Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
- Arrhythmias and/or history of arrythmia
- Psoriasis and/or history of psoriasis
- Neuropathy or myopathy and/or history of these
- Hypoglycemia and/or history of hypoglycemia
- Pre-existing hepatic disease
- Pre-existing renal disease
- Use of antacids within 1 week
- Use of antibiotics within 1 week
- Pregnancy
- RT-PCR performed >3 days prior to enrollment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346667
Pakistan | |
Expo Covid Center | |
Lahore, Punjab, Pakistan | |
Mayo Hospital | |
Lahore, Punjab, Pakistan | |
Pakistan Kidney and Liver Institute | |
Lahore, Punjab, Pakistan |
Responsible Party: | Ammar Sarwar, Assistant Professor of Radiology, Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT04346667 |
Other Study ID Numbers: |
NBC-COVID19-02 |
First Posted: | April 15, 2020 Key Record Dates |
Last Update Posted: | March 10, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
COVID-19 Coronavirus Infections Asymptomatic Diseases Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |
Disease Attributes Pathologic Processes Hydroxychloroquine Chloroquine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents Amebicides |