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

United Nations Children's Fund (UNICEF)

Status and phase: Completed; Phase 3

Conditions: Progression; Covid19

Treatments: Drug: HCQ

Study type: Interventional

Funder types: Other

Identifiers

NCT04491994

Sultan Mehmood Kamran 2

Details and patient eligibility

About

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

Full 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.

Enrollment: 540 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

540 participants in 2 patient groups

Standard of Care (SOC)

No Intervention group

Description:

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).

HCQ arm

Experimental group

Description:

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

Treatment:

Drug: HCQ