Covid19
Conditions
Brief summary
The main objective of this study is to evaluate the efficacy of human C1 inhibitor, administered alone or in combination with icatibant (a specific bradykinin B2 receptor antagonist) on the pulmonary manifestations of COVID-19 infections.
Detailed description
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.
Interventions
DRUGC1 Inhibitor Human
standard care + 1000 units of C1 inhibitor during 2 slow infusions of 500 units
DRUGIcatibant Injection
a single injection of 30 mg subcutaneously
OTHERPlacebo
The placebo will be physiological serum presented in forms mimicking the C1-Inhibitor and the icatibant.
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blind
Intervention model description
Prospective, randomized, double-blind, multicentre, prospective study of three parallel groups of patients.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy evaluation respiratory discomfort | 96 hours after the administration of treatment | To evaluate the efficacy of human C1 inhibitor, administered alone or in combination with icatibant (a specific bradykinin B2 receptor antagonist) on the pulmonary manifestations of COVID-19 infections. The evaluation of the treatment efficacy of the study is based on the clinical monitoring of the patient and particularly on the following combination of criteria as experienced by the patient : * no respiratory discomfort * heart rate between 60 and 90 /min * respiratory rate less than 20/min * O2 saturation greater than 94% without oxygen supply |
| Efficacy evaluation heart rate between 60 and 90 /min | 96 hours after the administration of treatment | To evaluate the efficacy of human C1 inhibitor, administered alone or in combination with icatibant (a specific bradykinin B2 receptor antagonist) on the pulmonary manifestations of COVID-19 infections. The evaluation of the treatment efficacy of the study is based on the clinical monitoring of the patient and particularly on the following combination of criteria as experienced by the patient : * no respiratory discomfort * heart rate between 60 and 90 /min * respiratory rate less than 20/min * O2 saturation greater than 94% without oxygen supply |
| Efficacy evaluation respiratory rate less than 20/min | 96 hours after the administration of treatment | To evaluate the efficacy of human C1 inhibitor, administered alone or in combination with icatibant (a specific bradykinin B2 receptor antagonist) on the pulmonary manifestations of COVID-19 infections. The evaluation of the treatment efficacy of the study is based on the clinical monitoring of the patient and particularly on the following combination of criteria as experienced by the patient : * no respiratory discomfort * heart rate between 60 and 90 /min * respiratory rate less than 20/min * O2 saturation greater than 94% without oxygen supply |
| Efficacy evaluation O2 saturation greater than 94% without oxygen supply | 96 hours after the administration of treatment | To evaluate the efficacy of human C1 inhibitor, administered alone or in combination with icatibant (a specific bradykinin B2 receptor antagonist) on the pulmonary manifestations of COVID-19 infections. The evaluation of the treatment efficacy of the study is based on the clinical monitoring of the patient and particularly on the following combination of criteria as experienced by the patient : * no respiratory discomfort * heart rate between 60 and 90 /min * respiratory rate less than 20/min * O2 saturation greater than 94% without oxygen supply |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance evaluation | Day 10 | The tolerance of the study products will be assessed by collecting adverse events that occurred during the study period. |
Countries
France
Outcome results
None listed