COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04469491

Jean-Philippe Lanoix

Not reported

2020-07-14

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - age ≥ 18 years old - patient with laboratory-confirmed sars-cov-2 infection as determined by pcr < 96 h (at initial diagnosis or persistent carriage <96 h) - hospitalized patient with covid-19 requiring oxygen therapy and targeting in phase b : - patients under oxygen therapy such as nasal cannula/mask or non-invasive ventilation with pao2/fio2 > 200 mmhg. - patients hospitalized for less than 7 days. - patients with symptoms for less than 10 days or rt-pcr (<96h) with cycle treshold < 25. - social security coverage - signed informed consent (by patient or their legally authorized representative)

- hypersensitivity to natural or recombinant interferon-ß - hypersensitivity to human albumin or mannitol - recent suicide attempt - decompensation of liver failure - age < 18 years - pregnant or nursing. - patients managed on an outpatient basis (i.e. not initially hospitalized). - parenteral ifn treatment. in periode b, addition of new exclusion criteria - patients with kidney transplant - immunocompromised patients - patients with severe systemic disease constantly threatening their vital prognosis (asa ≥ iv: e.g. severe arf, advanced cancer pathology, recent myocardial idm, severe valvular dysfunction, dependence on parenteral nutrition on central line, shock, sepsis, trauma, ...). - patients in septic shock. - patients with documented fungal infection. - patients on mechanical ventilation. - patients hospitalized for covid-19 for more than 7 days.

2

Centre Hospitalier Universitaire, Amiens

18

100

France

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

75

oxygen requirement score at day 0;Variation oxygen requirement score between day 0 and day15;oxygen requirement score at day 15

None

Phase 2

[{"arm_notes": "", "treatment_id": 1324, "treatment_name": "Type 1 interferon", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]