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

Texas Cardiac Arrhythmia Research Foundation

Status: Withdrawn

Conditions: COVID-19

Treatments: Drug: Hydroxychloroquine Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT04371926

TCAI_PREVENT

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 months to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

HCQ arm

Active Comparator group

Description:

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

Treatment:

Drug: Hydroxychloroquine Sulfate

No-HCQ arm

No Intervention group

Description:

Will receive standard treatment as needed, but no HCQ