Back to resultsHydroxychloroquine in COVID-19 Patients
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Hydroxychloroquine
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
Confirmed cases of SARS-CoV-2 by PCR
Exclusion Criteria:
less than 18 years old known hypersensitivity to the drug
Sites / Locations
- SNHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hydroxycholoroquine group
Control group
Arm Description
Outcomes
Primary Outcome Measures
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
% of mortality
total number of deaths divided by total number of the group
Secondary Outcome Measures
Length of stay
time from patients randomization till discharge
time to be afebrile
time from randomization till day of fever subsiding
need for mechanical ventilation
%of deteriorated patients necessitates mechanical ventilation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04394442
Brief Title
Hydroxychloroquine in COVID-19 Patients
Official Title
Use of Hydroxychloroquine in Patients With COVID-19: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 21, 2020 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Samah Lutfy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydroxycholoroquine group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
400mg BD first day then 200 mg BD for 5 days
Primary Outcome Measure Information:
Title
time to viral clearance
Description
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
Time Frame
21 days after patients randomization
Title
% of mortality
Description
total number of deaths divided by total number of the group
Time Frame
60 days after randomization
Secondary Outcome Measure Information:
Title
Length of stay
Description
time from patients randomization till discharge
Time Frame
60 days after randomization
Title
time to be afebrile
Description
time from randomization till day of fever subsiding
Time Frame
60 days after randomization
Title
need for mechanical ventilation
Description
%of deteriorated patients necessitates mechanical ventilation
Time Frame
60 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed cases of SARS-CoV-2 by PCR
Exclusion Criteria:
less than 18 years old known hypersensitivity to the drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samah M Lutfy, MD
Phone
+966581244415
Email
omar1star2008@yahoo.com
Facility Information:
Facility Name
SNH
City
Mecca
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samah Lutfy, MD
Phone
+966581244415
Email
omar1star2008@yahoo.com
12. IPD Sharing Statement
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Hydroxychloroquine in COVID-19 Patients
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