Clinical trial NCT04491994: Clearing the Fog: Is Hydroxychloroquine Effective in Reducing COVID-19 Progression
Official title: Clearing the Fog: Is HCQ Effective in Reducing COVID-19 progression-a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Progression
Keywords: COVID-19
viral clearance
, mild infection
disease progression
trial
HCQ
Lead sponsor: UNICEF
Sponsor class: OTHER
Collaborators: name: Pak Emirates Military Hospital
First posted: 2020-07-30
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization rules were designed by Dr. Wasim Alamgir together with principal investigators and implemented by an independent statistician who was not involved in data analysis. Stratified random sampling was applied to stratify all eligible patients according to age, gender and comorbidities. Computerized random number generator was used and allocation was done in 2:1 sequence. Cards with each group assignment number randomly generated by computer were placed in sequentially numbered envelopes that were opened as the patients were enrolled
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Progression
timeFrame: 5 days
Secondary outcomes:
measure: Viral Clearance
timeFrame: 14 days
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pak Emirates Military Hospital
state: Punjab
Study officials:
affiliation: Pak Emirates Military Hospital (PEMH) Rawalpindi
name: Imran m Fazal, FCPS
role: STUDY_DIRECTOR
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