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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-10

Study Completion Date

2020-05-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Covid19 Progression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Neither patients, nor investigators, nor statisticians were masked to treatment assignment. Lab staff who performed sampling for PCR, basic blood tests and other routine measurement were unaware of treatment information.

Study Groups

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Standard of Care (SOC)

Patients selected in supportive arm will be given daily standard doses of oral Vit C (2g), Vit D (alfacalcidiol 1µg), Zinc (50mg) and paracetamol (as required).

Group Type NO_INTERVENTION

No interventions assigned to this group

HCQ arm

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

Group Type EXPERIMENTAL

HCQ

Intervention Type DRUG

Tab HCQ 400mg 12 hourly day 0 followed by tab HCQ 200mg 12 hrly for next 5 days

Interventions

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HCQ

Tab HCQ 400mg 12 hourly day 0 followed by tab HCQ 200mg 12 hrly for next 5 days

Intervention Type DRUG

Other Intervention Names

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HCQ + Standard of Care (SOC)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No