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Hydroxychloroquine in patients with mild COVID-19 illness with risk factors for severe disease

An open label randomised controlled trial to assess the efficacy of Hydroxychloroquine in patients with mild COVID -19 illness with risk factors for severe disease.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025022
Enrollment
166
Registered
2020-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Tab Hydroxycholoroquine on day 1 followed by 400 mg OD for 5 days: the efficacy of HCQ as treatment for mild COVID-19 with high risk will be elucidated. the safety of HCQ as treatment f

Sponsors

AIIMS Department of Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with RT-PCR confirmed mild COVID-19 illness with high risk factors 2. Age > 18 years 3. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients without any of the high risk factors for severe illness 2. Pregnant women 3. Known hypersensitivity to HCQ 4. Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency

Design outcomes

Primary

MeasureTime frame
Progression to moderate- severe diseaseTimepoint: 6 month

Secondary

MeasureTime frame
1.Time to clinical resolution of symptoms 2.Incidence of adverse events Timepoint: 6 months-Analysis and final report of results

Countries

India

Contacts

Public ContactDr Manish Soneja

AIIMS

manishsoneja@gmail.com9013074717

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026