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

NCT ID: NCT04371926

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2021-07-31

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

HCQ arm

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

Group Type: ACTIVE_COMPARATOR

Hydroxychloroquine Sulfate

Intervention Type: DRUG

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

No-HCQ arm

Will receive standard treatment as needed, but no HCQ

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hydroxychloroquine Sulfate

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

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Cardiac Arrhythmia Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Andrea Natale

Executive Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Natale, MD

Role: PRINCIPAL_INVESTIGATOR

St. David's Medical Center

Other Identifiers

TCAI_PREVENT

Identifier Type: -

Identifier Source: org_study_id