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

Not Applicable

Withdrawn

• Conditions: COVID-19
• Interventions: Drug: Hydroxychloroquine Sulfate

• Registration Number: NCT04371926
• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-05-01
• Study Start: 2020-06
• Last Update Submitted: 2020-06-01
• Last Update Posted: 2020-06-04
• Primary Completion: 2021-06
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCQ arm	Hydroxychloroquine Sulfate	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

Primary Outcome Measures

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

Secondary Outcome Measures

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