COVID-19 trials registries data warehouse

https://slctr.lk/trials/slctr-2020-011

Niriella MA

maduniln@yahoo.co.uk

2020-05-04

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

1. All consenting male and female adult Naval personnel (18-59.9 years of age) 2. Exposure to a patient with confirmed COVID-19 infection (rRT-PCR positive for SARS-CoV-2 virus) 3. The exposure should be for >30 mins within 2 meters of the infected individual and should be within ONE WEEK at the time of inclusion in the study 4. Recruited within 48 hours of admission to these centers 5. Willing to take study drug as directed for 5 days.

1. Pregnant females 2. Suspected or confirmed to have COVID-19 infection (i.e Navy personnel having positive rRT-PCR test for COVID-19 or presence of fever with cough, shortness of breath, sore throat, anosmia or diarrhoea at the time of recruitment) 3. Presence of pre-existing cardiovascular disease including being on medication for ischaemic heart disease 4. Presence of contraindication to the use of HCQ (on other medications predisposing to long QT or presence of long QT on baseline ECG) 5. Prior diagnosis of retinopathy, G6PD, malignancy or advanced kidney disease 6. Known sensitivity or allergy to Hydroxychloroquine

2

Department of Medicine; Faculty of Medicine; University of Kelaniya

18

60

Sri Lanka

Health workers

N/A

400200

Number of participants symptomatic for COVID-19. (Symptomatic illness will be defined as presence of fever with cough; shortness of breath; sore throat; anosmia or diarrhoea) [Time frame: from the time of recruitment until the completion of 14 days]Number of participants testing positive for SARS-CoV-2 virus using rRT-PCR [ Time frame: day 14 from the time of recruitment]

Phase 4

[{"arm_notes": "the website is unusual. ", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "the website is unusual. ", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]