None listed
Conditions
Interventions
None listed
Sponsors
AIIMS Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: 1.Any Asymptomatic Medical professional (MP) of either sex (including pregnant and lactating female), >18 years of age and > 45 kg of weight, based in a primary, secondary or tertiary healthcare setting, who is already taking or willing to take chloroquine prophylaxis in anticipation of high risk of developing COVID-19 due to his/her potential exposure to patients with SARS-CoV-2 infection or having risk of this infection. 2.Special inclusion of MPs for case control arm will be: a.Those who are reluctant to take any prophylaxis b.MP with history of the following conditions: Retinopathy or retinal disease; Cardiomyopathy; Cardiac arrhythmia; Prolonged QTc; Psoriasis; Porphyria cutanea tarda; Epilepsy; Myasthenia gravis; Myopathy of any cause; Serious hepatic or renal disease; Glucose-6-phosphate dehydrogenase deficiency (G6PD); Severe depression which prevent chloroquine use c.Self-reported current use of medication with known serious hepatotoxic effects or known interaction with chloroquine/ hydroxychloroquine as listed in appendix 3 which prevent chloroquine use.
Exclusion criteria
Exclusion criteria: 1.Weight outside range 45 kg â?? 150 kg (99 lbs â?? 330 lbs). 2.Prior enrolment into this observational study. 3.Self-reported or diagnosed infection with SARS-CoV-2 or previous COVID-19 diagnosis within the last 6 months. 4.Self-reported current acute respiratory infection 5.Inability or unwillingness to be followed up for the trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Incidence of Symptomatic COVID-19 in each one of 4 arms; Clinical diagnosis of COVID-19 with virology confirmation, with limitation of activities (WHO Severity Scale 2-8) over the study enrolment period. (2) Incidence of Peak severity of COVID-19 over the study period in COVID-19 positive MPs Timepoint: at multiple intervals over 3months | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)The incidence of: pneumonia; respiratory failure requiring intubation; acute respiratory distress syndrome; delirium; shock requiring vasopressor medications; sepsis; acute kidney injury; acute liver injury; death. Case definitions will be decided a priori. (2)Duration of intensive care unit stay, hospital day. (3)Population pharmacokinetic evaluation based on sparse sampling methodology if possible. Timepoint: 30days | — |
Countries
India
Contacts
Public ContactPrasan Kumar Panda
AIIMS Rishikesh
Outcome results
None listed