Status:
COMPLETED
A Preventive Treatment for Migrant Workers at High-risk of COVID-19
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Covid-19
Eligibility:
MALE
21-60 years
Phase:
PHASE3
Brief Summary
In December 2019, a novel coronavirus, now called COVID-19, emerged as a global health threat from Wuhan, China. Within weeks, the contagious virus spread within and between communities, causing a low...
Detailed Description
This is a pragmatic, open-label, randomised study with 4 interventional and 1 control arms. Individuals will be recruited from migrant worker dormitories, and written informed consent taken prior to e...
Eligibility Criteria
Inclusion
- Subjects must meet all the of following criteria to be included in this study:
- Men residing in dormitory aged 21-60 years
- Willing and able to give informed consent
- Able to understand instructions and consume study medications according to the study protocol.
- Weight more than 40kg
- Owns a mobile phone (with wireless fidelity and/or 3G connection and able to fill in online forms.
Exclusion
- Subjects who have any of the following criteria at baseline will be excluded from participating in this study:
- Symptoms of acute respiratory illness (e.g. fever, runny nose, sore throat, cough, breathlessness, loss of smell and loss of taste) for the past 30 days
- Known current or history of SARS-CoV-2 infection
- Unable to read English or any of the available local languages used for this clinical trial
- History of cardiac or neurological diseases
- History of retinal diseases
- History of diabetes on insulin treatment
- History of depression
- History of chronic alcohol use
- History of renal or hepatic dysfunction
- History of glucose-6-phosphate dehydrogenase deficiency
- History of anaemia, after exposure to any given medications
- History of thyroid disorder, hyperthyroidism, or sensitivity to iodine
- History of allergies with systemic presentation to any given medication (e.g.: swelling of the face, throat, eyes and lips, respiratory disturbances, asthmatic attacks, widespread skin blistering or urticaria (hives))
- Concomitant medication that may lead to cardiac arrhythmia (azithromycin, amitriptyline, cimetidine, citalopram, nortriptyline, pantoprazole, quetiapine etc).
- Unwilling to comply with study dosing, instructions or restrictions.
Key Trial Info
Start Date :
May 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
4257 Patients enrolled
Trial Details
Trial ID
NCT04446104
Start Date
May 13 2020
End Date
August 31 2020
Last Update
October 19 2020
Active Locations (1)
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1
Tuas South Dormitory
Singapore, Singapore