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

COVID-19 Clinical Trial

— PREVENT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04371926
• Other study ID #: TCAI_PREVENT
• Status: Withdrawn
• Phase: N/A
• Start date: June 2020
• Est. completion date: July 2021

Study information

• Verified date: April 2020
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to reach normal body temperature	Time to reach normal body temperature (TNBT), =37.50 C	1 month
Primary	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	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
Secondary	Worsening of symptoms in COVID-19 patients	Worsening of symptoms in COVID-19 patients requiring artificial ventilation during the study period	1 month