Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk (PREVENT)
Primary Purpose
COVID-19
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hydroxychloroquine Sulfate
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19
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:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
HCQ arm
No-HCQ arm
Arm 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
Will receive standard treatment as needed, but no HCQ
Outcomes
Primary Outcome Measures
Time to reach normal body temperature
Time to reach normal body temperature (TNBT), ≤37.50 C
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
Secondary Outcome Measures
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
Worsening of symptoms in COVID-19 patients
Worsening of symptoms in COVID-19 patients requiring artificial ventilation during the study period
Full Information
NCT ID
NCT04371926
First Posted
April 29, 2020
Last Updated
June 1, 2020
Sponsor
Texas Cardiac Arrhythmia Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04371926
Brief Title
Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Concerned about the adverse effects of HCQ
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Cardiac Arrhythmia Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HCQ arm
Arm Type
Active Comparator
Arm 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
Arm Title
No-HCQ arm
Arm Type
No Intervention
Arm Description
Will receive standard treatment as needed, but no HCQ
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine Sulfate
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to reach normal body temperature
Description
Time to reach normal body temperature (TNBT), ≤37.50 C
Time Frame
1 month
Title
Development of COVID-19 symptoms during HCQ preventive therapy in staff
Description
Development of fever and/or other symptoms of COVID-19 during the 1 month of the HCQ therapy
Time Frame
1 month
Secondary Outcome Measure Information:
Title
COVID-19 test result at follow-up in patients
Description
Viral RNA test results at day 6 will be compared between the HCQ vs no-HCQ group
Time Frame
6 days
Title
Worsening of symptoms in COVID-19 patients
Description
Worsening of symptoms in COVID-19 patients requiring artificial ventilation during the study period
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
St. David's Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk
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