COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04370015

Saira Burney, FRCP (Edin)

dr_syra@hotmail.com

2020-04-30

Unknown

RCT

Randomized

Parallel

Blind label

unclear

Prevention

inclusion criteria: - adult healthcare workers all genders ≥ 18 to ≤ 60 years of age upon study consent. - healthcare workers (doctors and nurses) at services hospital, lahore considered work at high-risk of sars-cov-2 exposure (defined below): - healthcare workers in corona triage areas. - healthcare workers in corona isolation units. - healthcare workers in corona icus. - healthcare workers in general medical wards. - healthcare workers in general surgical wards. - healthcare workers in other units not directly dealing with suspected corona patients e.g. endocrinology department - afebrile with no constitutional symptoms. - no household contact with confirmed active sars-cov-2 infection in the last 3 weeks. - negative pcr at visit 0. - willing and able to comply with scheduled visits, treatment plan, and other study procedures. - willing to not take any other medicines especially fluoroquinolones and macrolides for the duration of study. - signed informed consent, demonstrating that the subject understands the interventions required for the study and the purpose of the study.

- participation in other investigational clinical trials for the treatment or prevention of sars-cov-2 infection within 30days. - subjects unwilling to practice at least one highly effective method of birth control for the duration of the study. - having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia or prior history of glucose-6-phosphate dehydrogenase (g-6-pd) deficiency. - having h/o skin disorders e.g. dermatitis, psoriasis or porphyria. - taking any of the following medication: - anti-arrythmic agents including digoxin. - gi drugs including antacids, proton-pump inhibitors, cimetidine. - anti-cancer treatment including methotrexate, cyclosporin. - anti-diabetic agents including insulin. - corticosteroids. - drugs causing qt interval prolongation especially antidepressants, anti-epileptics and macrolides. - drugs affecting electrolyte balance including diuretics, laxatives. - drug allergies: 4-aminoquinolines. - pre-existing retinopathy/maculopathy of the eye. - known chronic liver disease or cirrhosis, including hepatitis b and/or untreated hepatitis. - previous history of severe hypoglycaemia. - known case of renal disease. - untreated or uncontrolled active bacterial, fungal infection. - known or suspected active drug or alcohol abuse. - women who are pregnant or breastfeeding. - known hypersensitivity to any component of the study drug. - a known history of prolonged qt syndrome or history of additional risk factors for arrythmias (e.g., heart failure, family history of long qt syndrome). - known h/o respiratory disorders e.g. asthma, chronic obstructive pulmonary disease.

2

Services Institute of Medical Sciences, Pakistan

18

60

None

Health workers

N/A

374

Prevention of SARS-CoV-2 as determined by negative RT-PCR at the end of 12 week study period;Safety as determined by presence or absence of any adverse event related with hydroxychloroquine treatment

None

Not reported

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