COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04357457

Yonathan FREUND

yonathman@gmail.com

2020-04-22

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - adults patients aged 80 years or less - covid-19 diagnosis defined as either positive rt-pcr for sars-cov-2 or covid-19 compatible or typical chest ct pattern or positive serology for covid-19 antibodies - hypoxemic acute respiratory failure with the following criteria: oxygen saturation level of 92% or less, as measured by pulsed oximetry (spo2) under oxygen therapy with an oxygen rate of 6l/min or more. - hospital admission for covid-19 within 14 days - patients affiliated

- hypersensitivity to the active substance or to any of the excipients - pregnancy or breastfeeding woman - known hepatic failure (pt <50%, factor v < 50%) - last known plasma total bilirubin > 21 μmol/l - lactate level > 4 mmol/l - alt and ast levels greater than 3 times the upper limit - pulmonary hypertension (paps ≥37 mmhg and/or vmaxit ≥ 2,9 m/s) or right ventricular dysfunction - history of pulmonary embolism - diagnosis of pulmonary embolism during the current hospitalization or on-going anticoagulant therapy at curative dose for thromboembolism when hospitalized - paco2 > 45 mmhg - exacerbation of asthma or chronic respiratory failure - cardiogenic pulmonary oedema - systolic blood pressure of 90 mmhg or less, or use of vasopressors - urgent need for endotracheal intubation at the discretion of the treating physician - do-not-intubate order or estimated life expectancy less than 6 months - participation in another interventional research

2

Assistance Publique - Hôpitaux de Paris

18

75

France

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

181

Rate of endotracheal intubation

None

Phase 3

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 68, "treatment_name": "Almitrine", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}]