None listed
Conditions
Interventions
Intervention1: Hydroxychloroquine sulphate: Oral tablet 400 mg twice a day on Day 1, followed by 400 mg once weekly for next 7 weeks to be taken with meals
Control Intervention1: Not applicable: Singl
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Asymptomatic Health Care workers (HCWs) of any gender and conditions as follows: age 18 -65 years (HCW who are actively on duty and not any who have retired) on prophylaxis with HCQ against COVID-19 infection â?? Group 1 without comorbiditie age 18 -65 years (HCW who are actively on duty and not any who have retired) who are to be initiated on prophylaxis â?? Group 2 without comorbidities age 18 -65 years (HCW who are actively on duty and not any who have retired) on prophylaxis with HCQ against COVID-19 infection with comorbidities (HT, Diabetes) â?? Group3 age 18 -65 years (HCW who are actively on duty and not any who have retired) who are to be initiated on prophylaxis â?? Group 2 with comorbidities (HT, Diabetes)
Exclusion criteria
Exclusion criteria: Health care workers who show symptoms suggestive of COVID-19 or are positive for COVID-19 Women of child bearing potential who are not willing for adequate contraception during the time of blood collection / who were not practicing adequate contraception in the last 28 days Women who are pregnant or breast feeding Participants who are not determined to be fit by the investigator Participants who are prescribed HCQ for any other indication / history of taking HCQ in the last one year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The modelling will help assess which of the variables including the presence of comorbidities (if any) would have the greatest impact on the drug concentrations in an Indian population. It would also help us understand if COVID-19 infection alters the pharmacokinetics of HCQ.Timepoint: 2-8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| It would also help us understand the concentrations of HCQ in lung fluid using PBPK modellingTimepoint: 2-8 weeks | — |
Countries
India
Contacts
Public ContactDr Nithya Gogtay
Department of Clinical Pharmacology Seth GSMC and KEM Hospital
Outcome results
None listed