Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study). (AntagoBrad)
Covid19
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
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
Sites / Locations
- Hôpital Privé de Parly II
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
standard care + C1 inhibitor
standard care + Icatibant + C1 inhibitor
standard care + placebo
The C1 inhibitor will be used at a dose of 1000 units per slow infusion (two hours). Two infusions will be given 24 hours apart. These doses correspond to the usual doses used in the treatment of conditions in which the C1-Inhibitor is indicated.
The C1 inhibitor will be used at a dose of 1000 units per slow infusion (two hours). Two infusions will be given 24 hours apart. These doses correspond to the usual doses used in the treatment of conditions in which the C1-Inhibitor is indicated. The icatibant will be used in a single injection of 30 mg subcutaneously, preferably in the abdominal region. These doses correspond to the doses usually used in the treatment of conditions in which icatibant is indicated.