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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371926
Recruitment Status : Not yet recruiting
First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Sulfate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
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

Masking: Single (Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Time to reach normal body temperature [ Time Frame: 1 month ]
    Time to reach normal body temperature (TNBT), ≤37.50 C

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Angel Mayedo, MD 512-544-7254 angel.mayedo@stdavids.com
Contact: Bryan MacDonald, MD 512-544-7252 bryan.macdonald@stdavids.com

Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
Investigators
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Principal Investigator: Andrea Natale, MD St. David`s Medical Center
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Responsible Party: Andrea Natale, Executive Medical Director, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT04371926    
Other Study ID Numbers: TCAI_PREVENT
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents