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A study to estimate drug levels in health care workers on COVID infection prophylaxis

Measurement of Hydroxychloroquine in blood in asymptomatic healthcare workers on prophylactic regimen for COVID-19 infection - An observational study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/05/025466
Enrollment
24
Registered
2020-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Nil.: Nil. Control Intervention1: Nil.: Nil.

Sponsors

Norwich Clinical Services PvtLtd
Lead Sponsor
Division of Clinical Research and Training St Johns Research Institute
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: a. Able to give voluntary informed consent for collection of blood samples and relevant data for analysis and publication. b. Either gender, aged above 18 years.

Exclusion criteria

Exclusion criteria: a. Volunteers who are already on hydroxychloroquine prophylaxis and have less than 5 weeks remaining out of 8 weeks of hydroxychloroquine prophylaxis for COVID-19 infection. b. Volunteers who are already on hydroxychloroquine prophylaxis and develop any adverse drug reaction (ADR) to hydroxychloroquine leading to hospitalization or discontinuation at any time.

Design outcomes

Primary

MeasureTime frame
To determine the peak and trough values achieved in blood over the course of the prophylactic drug administration.Timepoint: The estimated concentration for the sampling time points (hr) 0.00, 4.00, 168.00, 336.00, 340.00, 504.00, 672.00, 676.00, 840.00, 1008.00 and 1176.00 will be reported with descriptive statistical analysis.—

Secondary

MeasureTime frame
Hydroxychloroquine levels achieved in blood will be compared with literature values of EC 50.Timepoint: The estimated concentration for the sampling time points (hr) 0.00, 4.00, 168.00, 336.00, 340.00, 504.00, 672.00, 676.00, 840.00, 1008.00 and 1176.00 will be reported with descriptive statistical analysis.—

Countries

India

Contacts

Public ContactDr Rajeev M Patil

Norwich Clinical Services Pvt. Ltd.

rajeev.patil@norwichclinical.com91-94825-72525

Outcome results

None listed

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