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A randomized controlled trial of hydroxychloroquine prophylaxis for Healthcare Workers exposed to COVID-19

A randomized controlled trial of hydroxychloroquine prophylaxis for Healthcare Workers exposed to COVID-19

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025067
Enrollment
6950
Registered
2020-05-06
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

None listed

Interventions

Intervention1: hydroxychloroquine along with Standard care Personal protective equipment: 800 mg of hydroxychloroquine on the day of enrollment and 400mg once a week after that for a total of 12 weeks

Sponsors

George Institute for Global Health India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All HCWs directly exposed to confirmed COVID-19 patients.

Exclusion criteria

Exclusion criteria: Participants who meet any of following criteria will be are excluded 1. have a proven diagnosis of COVID-19 infection 2. are currently taking chloroquine or HCQ 3. are pregnant 4. are breast feeding 5. known QT prolongation 6. history of serious cardiac dysrhythmias or cardiomyopathy 7. have maculopathy of the eye (a contra-indication to HCQ) 8. are immunocompromised because of a disease or therapy 9. pregnant women

Design outcomes

Primary

MeasureTime frame
Proportion of laboratory confirmed symptomatic COVID-19 cases between the groups at the end of 6 monthsTimepoint: Proportion of laboratory confirmed symptomatic COVID-19 cases between the groups at the end of 6 months

Secondary

MeasureTime frame
1. hospitalization due to suspected COVID-19 disease, 2. admission with suspected COVID-19 to either an ICU or HDU , 3. all-cause mortality, 4.organ failure 5. duration of ICU or HDU stay, 6. Need for vasopressors 7. Need for renal replacement 8. duration of hospitalization, 9. readmission to hospital 10.days off workTimepoint: From randomization till the study end

Countries

India

Contacts

Public ContactProfessor Vivekanand Jha

The George Institute for Global Health, India

vjha@georgeinstitute.org.in911141588091

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 26, 2026