COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04653831

Not reported

Not reported

2020-12-04

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - men and women between the ages 18-80 years - diagnosis of covid19 with severe ards (pao2/fio2 <150mmhg) - admission to the icu and in need of mechanical ventilation - able to give informed consent according to local regulations. if the patient is unable to give written informed consent, the form will be read to them and their verbal consent will be documented. if the patient is sedated, an impartial icu physician will approve eligibility.

- previous use of nintedanib or pirfenidone - administration of fluvoxamine 7 days prior to admission to icu - severe hepatic impairment (liver enzymes and bilirubin>2 of normal upper limit, at day 0) or end stage liver disease - severe renal impairment (crcl <30 ml/min) or end stage renal disease requiring dialysis - pregnancy - participation in any other clinical trial 30 days prior to enrollment

2

Soroka University Medical Center

18

80

Israel

Critical disease at enrollment

8: Critical disease at enrollment

26

Ventilation free days to day 28 (VFD28);Severe adverse events (SAEs) rate

None

Not reported

[{"arm_notes": "", "treatment_id": 995, "treatment_name": "Pirfenidone", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]