Hydroxychloroquine in COVID-19 Patients

Phase 2

• Conditions: COVID-19
• Interventions: Drug: Hydroxychloroquine

• Registration Number: NCT04394442
• Lead Sponsor: Samah Lutfy

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-21
• Status Verified: 2020-05
• Study First Submitted: 2020-05-17
• Study First Submitted QC: 2020-05-18
• Last Update Submitted: 2020-05-18
• Study First Posted: 2020-05-19
• Last Update Posted: 2020-05-19
• Primary Completion: 2020-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Confirmed cases of SARS-CoV-2 by PCR

Exclusion Criteria

less than 18 years old known hypersensitivity to the drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydroxycholoroquine group	Hydroxychloroquine	-

Primary Outcome Measures

Name	Time	Method
time to viral clearance	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
% of mortality	60 days after randomization	total number of deaths divided by total number of the group

Secondary Outcome Measures

Name	Time	Method
need for mechanical ventilation	60 days after randomization	%of deteriorated patients necessitates mechanical ventilation
Length of stay	60 days after randomization	time from patients randomization till discharge
time to be afebrile	60 days after randomization	time from randomization till day of fever subsiding

Trial Locations

Locations (1)

SNH; 🇸🇦 Mecca, Saudi Arabia