Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04323631|
Recruitment Status : Withdrawn (Trial not started due to accumulating evidence against HCQ for COVID)
First Posted : March 26, 2020
Last Update Posted : June 30, 2020
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Hydroxychloroquine Other: The control group will not receive hydroxychloroquine||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death|
|Actual Study Start Date :||April 30, 2020|
|Actual Primary Completion Date :||April 30, 2020|
|Actual Study Completion Date :||April 30, 2020|
Experimental: The intervention group
The 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
The control group will not receive hydroxychloroquine.
Other: The control group will not receive hydroxychloroquine
The control group will not receive hydroxychloroquine
- Number patients developing severe infection or death [ Time Frame: within 28 days ]Number patients developing severe infection or death
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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%)
- 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
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): NCT04323631
|Principal Investigator:||Paul||Rambam MC|
|Responsible Party:||Rambam Health Care Campus|
|Other Study ID Numbers:||
|First Posted:||March 26, 2020 Key Record Dates|
|Last Update Posted:||June 30, 2020|
|Last Verified:||June 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action