Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk

Study Overview
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Brief Summary
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Few studies have reported the efficacy of HCQ in reducing the viral load and improving the severity of symptoms in hospitalized COVID-19 cases with serious respiratory infection. However, the prophylactic benefits of HCQ has not been clearly defined yet.

Detailed Description
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This study is designed to evaluate the prophylactic efficacy of HCQ in COVID-19 cases with mild to moderate symptoms and in the hospital staff engaged in attending infected patients.

Official Title
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Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk (PREVENT)

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Hydroxychloroquine Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female over 18 years of age at the time of enrollment COVID-19 test positive patients with mild-moderate symptoms including fever >37.50 F Consecutive consenting staff at ICU, ER and COVID-19 unit that have never been diagnosed with COVID-19 Exclusion Criteria: Exclusion criteria: Hepatic cirrhosis or active hepatitis B or C Severe renal disease Hospitalized for severe symptoms of COVID-19 (ARDS), on mechanical ventilation or ECMO Contraindication to HCQ Using HCQ for some other condition (i.e. SLE, rheumatoid arthritis) Pregnant or breast feeding Known history of long QT syndrome (QTc >500 ms on electrocardiogram) Seizure disorder Body weight <50kg Psoriasis Unwilling to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 85 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Symptomatic patients will be randomized to hydroxychloroquine (HCQ) vs no-HCQ group. Similarly, hospital staff with high risk of exposure will be randomized to HCQ vs no-HCQ group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HCQ arm<br>COVID-19 positive cases will receive receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course. Staff randomized to this group will receive HCQ sulfate 400 mg/week for 4 weeks | Drug: Hydroxychloroquine Sulfate<br>* Patients will receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course. Staff will receive HCQ sulfate 400mg/week for 4 weeks<br>|
| No Intervention: No-HCQ arm<br>Will receive standard treatment as needed, but no HCQ | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach normal body temperature | Time to reach normal body temperature (TNBT), ≤37.50 C | 1 month | 
| Development of COVID-19 symptoms during HCQ preventive therapy in staff | Development of fever and/or other symptoms of COVID-19 during the 1 month of the HCQ therapy | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 test result at follow-up in patients | Viral RNA test results at day 6 will be compared between the HCQ vs no-HCQ group | 6 days | 
| Worsening of symptoms in COVID-19 patients | Worsening of symptoms in COVID-19 patients requiring artificial ventilation during the study period | 1 month |