COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04402203

Ahmedul Kabir, MBBS, FCPS, FACP, FRCP

ahmedul_986@yahoo.com

2020-05-26

Unknown

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: age: male or female patients 18 -65 years old respiratory samples tested positive for the novel coronavirus. initial symptoms will within 7 days nonpregnant women (confirmed by urine human chorionic gonadotropin (hcg) test prior to enrollment)

severe clinical condition (meeting one of the following criteria: a resting respiratory rate greater than 30 per minute, oxygen saturation below 93%, oxygenation index (oi) < 300 mmhg (1 mmhg = 133.3 pa), respiratory failure, shock, and/or combined failure of other organs that required icu monitoring and treatment). chronic liver and kidney disease and reaching end stage. (serum aspartate aminotransferase (ast) and serum alanine aminotransferase (alt) will be elevated over 5 times of normal upper range will excluded). (normal upper limit of serum ast = 40 units /l, alt = 56 units /l) serum uric acid >7.0 mg/dl in male and serum uric acid >6.0 mg/dl in female will excluded icu patient previous history of allergic reactions to favipiravir. pregnant or lactating women women of a childbearing age with a positive pregnancy test. miscarriage, or within 2 weeks after delivery hypertensive patients, who are taking calcium channel blockers

2

Bangladesh Medical Research Council (BMRC)

18

65

Bangladesh

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

50

Number of participants with lung condition change assessed with X-ray.;Number of participants negative by RT-PCR for the virus at 4-10 days after initiation of therapy.

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]