Clearing the Fog: Is Hydroxychloroquine Effective in Reducing COVID-19 Progression

Phase 3

Completed

• Conditions: Covid19; Progression
• Interventions: Drug: HCQ

• Registration Number: NCT04491994
• Lead Sponsor: UNICEF

Brief Summary

Brief Summary: Purpose of this study is to evaluate efficacy of hydroxychloroquine (HCQ) in reducing progression of Corona Virus Disease 2019 (COVID - 19) and achieving viral clearance.

Condition or disease :I COVID-19 ntervention/treatment :Drug: Hydroxychloroquine Sulfate Phase: Phase III

Detailed Description

This study explores efficacy of HCQ (400mg BD on D0 and 200mg BD D1-D5) in reducing progression of Mild Covid-19 patients and decreasing viral load.

Participants of study will be randomized 2:1 to receive either Active drug or standard of care (SOC) treatment respectively. We aim to demonstrate reduced COVID-19 progression and early viral clearance in individuals on HCQ therapy.

Study Timeline

• Study Start: 2020-04-10
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-30
• Results First Submitted: 2020-07-31
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Results First Posted: 2020-08-21
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

• Mild Corona virus disease (COVID-19)
• PCR confirmed infection
• Hospital admitted patients

Exclusion Criteria

• Moderate, severe and critical COVID-19
• day 0 CRP greater than 6mg/dl, ALC < 1000 or evidence of infiltrates on X-ray chest
• comorbidity with life expectancy less than 6 months
• Contraindications to HCQ therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCQ arm	HCQ	Patients selected in experimental arm will be given Tab HCQ (400mg BD on D0 followed by 200mg BD D1-D5) in addition to supportive treatment

Primary Outcome Measures

Name	Time	Method
Number of Participants With Progression	5 days	After start of treatment, development of fever \> 101 F for \> 72 hours, shortness of breath by minimal exertion (10-Step walk test), derangement of basic lab parameters (ALC \< 1000 or raised CRP) or appearance of infiltrates on CXR during course of treatment was labeled as progression irrespective of PCR status

Secondary Outcome Measures

Name	Time	Method
Viral Clearance	14 days	PCR negativity on day 7 and 14 after admission

Trial Locations

Locations (1)

Pak Emirates Military Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan