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Hydroxychloroquine in COVID-19 Patients

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: NCT04394442
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Samah Lutfy, Zagazig University

Brief Summary:
Many reports argued about the possible beneficial effects of Hydroxychloroquine in treating COVID-19 patients and this study was designed to investigate this claim

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Hydroxychloroquine in Patients With COVID-19: A Randomized Controlled Clinical Trial
Actual Study Start Date : March 21, 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydroxycholoroquine group Drug: Hydroxychloroquine
400mg BD first day then 200 mg BD for 5 days

No Intervention: Control group



Primary Outcome Measures :
  1. time to viral clearance [ Time Frame: 21 days after patients randomization ]
    PCR will be done every 72 h day till 2 consecutive negative PCR tests(24h apart) which is the viral clearance.The time between randomization and viral clearance is the viral clearance time

  2. % of mortality [ Time Frame: 60 days after randomization ]
    total number of deaths divided by total number of the group


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: 60 days after randomization ]
    time from patients randomization till discharge

  2. time to be afebrile [ Time Frame: 60 days after randomization ]
    time from randomization till day of fever subsiding

  3. need for mechanical ventilation [ Time Frame: 60 days after randomization ]
    %of deteriorated patients necessitates mechanical ventilation



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 to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Confirmed cases of SARS-CoV-2 by PCR

Exclusion Criteria:

less than 18 years old known hypersensitivity to the drug


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): NCT04394442


Contacts
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Contact: Samah M Lutfy, MD +966581244415 omar1star2008@yahoo.com

Locations
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Saudi Arabia
SNH Recruiting
Mecca, Saudi Arabia
Contact: Samah Lutfy, MD    +966581244415    omar1star2008@yahoo.com   
Sponsors and Collaborators
Samah Lutfy
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Responsible Party: Samah Lutfy, Assistant professor of chest diseases, Zagazig University
ClinicalTrials.gov Identifier: NCT04394442    
Other Study ID Numbers: SNH1352020
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 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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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents