Study Stopped
Trial not started due to accumulating evidence against HCQ for COVID
Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This is a multi-center, randomized controlled, superiority, open label trial. The objective of this trial is to evaluate the efficacy of HCQ in patients with newly diagnosed COVID-19 who have mild to moderate disease or at risk for complications. We aim to demonstrate decrease in progression to severe pneumonia and hospital related complications among patients who are treated with HCQ compared to patients who are not.
Trial Health
Trial Health Score
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Started Apr 2020
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2020
CompletedFirst Posted
Study publicly available on registry
March 26, 2020
CompletedStudy Start
First participant enrolled
April 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedJune 30, 2020
June 1, 2020
Same day
March 25, 2020
June 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number patients developing severe infection or death
Number patients developing severe infection or death
within 28 days
Study Arms (2)
The intervention group
EXPERIMENTALThe intervention group will receive oral hydroxychloroquine. In the first day 400 mg twice daily, followed by 200mg twice daily on days 2-10 (continued after discharge if discharged before day 10).
The control group
OTHERThe control group will not receive hydroxychloroquine.
Interventions
The control group will not receive hydroxychloroquine
Eligibility Criteria
You may qualify if:
- Adult patients (\>18 years)
- Confirmed COVID-19 infection by real-time PCR from a respiratory or other body sample within 48 hours of testing.
You may not qualify if:
- Informed consent from patient or legal representative.
- Severe infection, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support.
- Unable to take oral medication
- Known allergy to HCQ or chloroquine
- Prolonged QT, defined as QTc ≥450 milliseconds for men and as QTc ≥470 for women
- Severely reduced LV function (Ejection fraction\<30%)
- Retinopathy
- Pregnancy or breast feeding
- Concomitant treatment with azithromycin, flecainide, amiodarone, digoxin, procainamide, propafenone, thioridazine, pimozide.
- Chronic chloroquine/ HCQ treatment (within 1 month)
- Need for hemodialysis
- Participating in another RCT for treatment of COVID-19
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rambam Health Care Campuslead
- Rabin Medical Centercollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul
Rambam MC
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2020
First Posted
March 26, 2020
Study Start
April 30, 2020
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
June 30, 2020
Record last verified: 2020-06