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NCT04394442 Clinical Trial

Hydroxychloroquine in COVID-19 Patients

COVID-19 Clinical Trial

Official title:
Use of Hydroxychloroquine in Patients With COVID-19: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04394442
Other study ID # SNH1352020
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 21, 2020
Est. completion date August 2020

Study information
Verified date May 2020
Source Zagazig University
Contact Samah M Lutfy, MD
Phone +966581244415
Email omar1star2008@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

Confirmed cases of SARS-CoV-2 by PCR

Exclusion Criteria:

less than 18 years old known hypersensitivity to the drug

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Hydroxychloroquine
400mg BD first day then 200 mg BD for 5 days

Locations
Country Name City State
Saudi Arabia SNH Mecca

Sponsors (1)
Lead Sponsor Collaborator
Samah Lutfy

Country where clinical trial is conducted

Saudi Arabia, 

Outcome
Type Measure Description Time frame Safety issue
Primary time to viral clearance 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 21 days after patients randomization
Primary % of mortality total number of deaths divided by total number of the group 60 days after randomization
Secondary Length of stay time from patients randomization till discharge 60 days after randomization
Secondary time to be afebrile time from randomization till day of fever subsiding 60 days after randomization
Secondary need for mechanical ventilation %of deteriorated patients necessitates mechanical ventilation 60 days after randomization
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