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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Withdrawn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
Texas Cardiac Arrhythmia Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Months - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 29, 2020
    Last Updated
    June 1, 2020
    Sponsor
    Texas Cardiac Arrhythmia Research Foundation
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    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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