Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk (PREVENT)
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|ClinicalTrials.gov Identifier: NCT04371926|
Recruitment Status : Withdrawn (Concerned about the adverse effects of HCQ)
First Posted : May 1, 2020
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Hydroxychloroquine Sulfate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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
|Official Title:||Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk (PREVENT)|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||July 2021|
Active Comparator: 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
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
No Intervention: No-HCQ arm
Will receive standard treatment as needed, but no HCQ
- Time to reach normal body temperature [ Time Frame: 1 month ]Time to reach normal body temperature (TNBT), ≤37.50 C
- Development of COVID-19 symptoms during HCQ preventive therapy in staff [ Time Frame: 1 month ]Development of fever and/or other symptoms of COVID-19 during the 1 month of the HCQ therapy
- COVID-19 test result at follow-up in patients [ Time Frame: 6 days ]Viral RNA test results at day 6 will be compared between the HCQ vs no-HCQ group
- Worsening of symptoms in COVID-19 patients [ Time Frame: 1 month ]Worsening of symptoms in COVID-19 patients requiring artificial ventilation during the study period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371926
|Principal Investigator:||Andrea Natale, MD||St. David's Medical Center|