Status:
WITHDRAWN
Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death
Lead Sponsor:
Rambam Health Care Campus
Collaborating Sponsors:
Rabin Medical Center
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 ...
Detailed Description
Inclusion criteria: * Adult patients (\>18 years) * Confirmed COVID-19 infection by real-time PCR from a respiratory or other body sample within 48 hours of testing. * Mild to moderate infection or a...
Eligibility Criteria
Inclusion
- Adult patients (\>18 years)
- Confirmed COVID-19 infection by real-time PCR from a respiratory or other body sample within 48 hours of testing.
- Mild to moderate infection or asymptomatic patients with comorbidities: Symptomatic patients with fever \>37.9ºC or cough or dyspnea or chest pain, not fulfilling severity exclusion criteria. We will include patients regardless of time since symptom onset. In addition, we will include asymptomatic patients with comorbidities including cardiac, pulmonary, diabetes, chronic renal failure or liver disease hospitalized for observation.
- Informed consent from patient or legal representative.
Exclusion
- 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
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04323631
Start Date
April 30 2020
End Date
April 30 2020
Last Update
June 30 2020
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