COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04344288

Jean-François MORNEX

Vincent COTTIN, vincent.cottin@chu-lyon.fr (PI email not reported)

2020-04-14

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - age ≥ 18 years old, - hospitalization for covid-19 infection confirmed by rt-pcr or other virological method, - peripheral saturation by pulse oximeter spo2 ≤ 94% in ambient air measured twice at 5-15 min intervals, or pao2 / fio2 <300 mmhg, - abnormalities on the chest x-ray or ct scan suggestive of viral pneumonia, - signed informed consent by the patient.

- covid-19 infection with first symptoms lasting for more than 9 days according to the patient's interview; d1 of symptoms is defined by the first day with fever, cough, shortness of breath, and / or chills related to covid-19 infection; - patients with primary or secondary immune deficiency, including: hiv, chronic hematological disease, solid organ transplant, ongoing immunosuppressive therapy, - long-term corticosteroid therapy defined by a prescription of more than 10 mg/d (prednisone equivalent), - suspected or confirmed infection with bacteria, fungal agents or viruses (in addition to covid-19), - known contraindication to systemic corticosteroids, - systolic blood pressure <80 mmhg, - spo2 <90% under 5 l / min of oxygen using medium concentration mask, or higher oxygen requirements, - patient on long-term oxygen therapy, - ongoing mechanical ventilation, - ongoing septic shock ongoing, - ongoing multi-organ failure ongoing, - participating in other covid-19 therapeutic clinical trial - pregnant or breast-feeding woman (oral diagnosis), - no affiliation or beneficiary of health insurance,

2

Hospices Civils de Lyon

18

None

France

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

11

Number of patients with a theoretical respiratory indication for transfer to intensive care unit evaluated by a SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask.

None

Phase 2

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