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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. 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: NCT04323631
Recruitment Status : Not yet recruiting
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Rabin Medical Center
Information provided by (Responsible Party):
Rambam Health Care Campus

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Other: The control group will not receive hydroxychloroquine Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1116 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Drug: Hydroxychloroquine
Oral

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




Primary Outcome Measures :
  1. Number patients developing severe infection or death [ Time Frame: within 28 days ]
    Number patients developing severe infection or death



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 Criteria:

  • 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

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): NCT04323631


Contacts
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Contact: Paul +972-50-2062140 M_paul@rambam.health.gov.il

Sponsors and Collaborators
Rambam Health Care Campus
Rabin Medical Center
Investigators
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Principal Investigator: Paul Rambam MC
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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT04323631    
Other Study ID Numbers: 0154-20-RMB
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020

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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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Infection
Disease Progression
Disease Attributes
Pathologic Processes
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents