A study to determine relative efficacy of hydroxy-chloroquine prophylaxis to healthcare-professionals for Covid-19 mitigatio
- Registration Number
- CTRI/2020/06/025593
- Lead Sponsor
- AIIMS Rishikesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Incidence of Symptomatic COVID-19 in each one of 4 arms; <br/ ><br>Clinical diagnosis of COVID-19 with virology confirmation, with limitation of activities (WHO Severity Scale 2-8) over the study enrolment period. <br/ ><br>(2) Incidence of Peak severity of COVID-19 over the study period in COVID-19 positive MPs <br/ ><br>Timepoint: at multiple intervals over 3months
- Secondary Outcome Measures
Name Time Method (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. <br/ ><br>(2)Duration of intensive care unit stay, hospital day. <br/ ><br>(3)Population pharmacokinetic evaluation based on sparse sampling methodology if possible. <br/ ><br>Timepoint: 30days