COVID-19 Clinical Trial
— PREVENTOfficial title:
Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk (PREVENT)
NCT number | NCT04371926 |
Other study ID # | TCAI_PREVENT |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2020 |
Est. completion date | July 2021 |
Verified date | April 2020 |
Source | Texas Cardiac Arrhythmia Research Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Texas Cardiac Arrhythmia Research Foundation |
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 |
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