Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).

Prospective, prospective, multicentre, double-blind, randomised, multi-centre study of three parallel groups of patients:

• Group 1 (n=15): standard of care + C1 inhibitor
• Group 2 (n=15): standard care + icatibant + C1 inhibitor
• Group 3 (n=15): standard support + placebo

The study has two parts:

• A 4-day (96-hour) therapeutic part during which the patient will be evaluated nine times (H0, H4, H12, H24, H36, H48, H60, H72 and H96).
• A follow-up part of 6 days with at least two assessments (D7 and D10).

The maximum duration of patient participation in the study will be 10 days.

Inclusion criteria

• Patient over 18 years of age, having read and signed the consent form for participation in the study after the reflection period (≤ 15 minutes)
• Patient screened for COVID+ by RT-PCR on nasopharyngeal swab
• Patient with at least three of the following respiratory signs:

• Temperature >38° C
• Non-productive dry cough
• Presence of crackling rales on auscultation
• Respiratory discomfort felt by the patient
• Heart rate > 90/min
• Respiratory rate >20/min
• O2 saturation ≤ 93%
• Patient whose clinical condition, in the opinion of the investigator, requires hospital monitoring.
• Patient who would have been monitored and treated outside of study participation, including prevention of thromboembolic risk with LMWH.

Exclusion criteria

• Patient with pre-existing respiratory disease (cancer, COPD, asthma, emphysema) or smoking history of > 25 years)
• Patient with a known allergy to one of the study products
• Patient treated with anti TNF, IL1 or IL6
• Patient requiring immediate intubation
• Patient on a low sodium diet
• Patient under protective custody, guardianship or trusteeship
• Patient not affiliated to the French social security system
• Patient participating in another therapeutic protocol
• Pregnant or likely to become pregnant (woman of childbearing age without effective contraception and without HCG dosage)
• Patient unable to understand informed information and/or give written informed consent: dementia, psychosis, consciousness disorders, non-French speaking patient