Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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SARS-CoV-2, Coronavirus Infection, Asymptomatic Condition, COVID-19

Intervention / Treatment
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* Drug: Hydroxychloroquine Sulfate Regular dose
* Drug: Hydroxychloroquine Sulfate Loading Dose
* Drug: Chloroquine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care | Drug: Hydroxychloroquine Sulfate Regular dose<br>* Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2<br>|
| Experimental: Arm 2<br>Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care | Drug: Hydroxychloroquine Sulfate Loading Dose<br>* Hydroxychloroquine administered as a loading dose only<br>|
| Active Comparator: Arm 3<br>Chloroquine 500 mg BID for 5 days plus standard of care | Drug: Chloroquine<br>* Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2<br>|
| Placebo Comparator: Arm 4<br>Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine) | Drug: Placebo<br>* Standard of Care plus placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RT-PCR negative status | Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7 | 6-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of symptoms | Time to progression to next stage of SARS-CoV-2 disease severity index | 7 days | 
| Development of Symptoms | Time to onset of fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute). | 7 days | 
| Adverse events | Drug related adverse events as determined by data safety and monitoring board (DSMB) | 7 days |