COVID positive patients with respiratory impairment MedDRA version: 23.1 Level: LLT Classification code 10084437 Term: COVID-19 PCR test positive System Organ Class: 100000004848 MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: BERINERT
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
INN or Proposed INN: C1-esterase inhibitor, human
Other descriptive name: C1 ESTERASE INHIBITOR (H
Sponsors
Groupement de Coopération Sanitaire Ramsay Générale de Santé pour l’Enseignement et la Recherche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient over 18 years of age, having read and signed the informed consent form for participation in the study after a reflection period (= 15 minutes) - Patient screened for COVID+ by RT-PCR on nasopharyngeal swab - Patient with at least three of the following respiratory signs: o Temperature >38° C o Non-productive dry cough o Presence of crackling rales at auscultation o Respiratory discomfort felt by the patient o Heart rate > 90/min o Respiratory rate >20/min o 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
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 - Patient pregnant or likely to become pregnant (woman of childbearing age without effective contraception and without HCG dosage) - Patient unable to understand information and/or give written informed consent: dementia, psychosis, consciousness disorders, non-French speaking patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of human C1 inhibitor, administered alone or in combination with icatibant (specific bradykinin B2 receptor antagonist) on the pulmonary manifestations of COVID-19 infections.;Secondary Objective: -Describe the effect of treatments on C1 inhibitor activity and kinin metabolism -Describe the effect of treatment on the cytokine imbalance induced by the infection. -Evaluate individual factors and genetic enzyme factors that may be considered predictive of a therapeutic response. -Evaluate the tolerance of the study products;Primary end point(s): Therapeutic success will be assessed at each evaluation. It is defined by the presence of all of the following 4 criteria during two successive examinations with stable results at 72 hours: Absence of respiratory discomfort + Heart rate between 60 and 90 /min + Respiratory rate less than 20/min + Saturation without external O2 greater than 95%. Failure to meet one of the above criteria at h72 and/or h96 defines a therapeutic failure, and imposes a change in medical care.;Timepoint(s) of evaluation of this end point: total number of evaluations = 11 (H0, H4, H12, H24, H36, H48, H60, H72 and H96, follow up: D7 and D10) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Assessment of functional activity of C1 inhibitor -Assessment of kinin metabolism -Examination of enzymatic genetic polymorphism (at inclusion) -Collection of adverse events;Timepoint(s) of evaluation of this end point: -Assessment of functional activity of C1 inhibitor -Assessment of kinin metabolism Total number of evaluations = 11 (H0, H4, H12, H24, H36, H48, H60, H72 and H96, follow up: D7 and D10) -For the examination of enzymatic genetic polymorphism: only at inclusion. -Continuous collection of adverse events | — |
Countries
France
Contacts
Public ContactSAHBANE
VIVACTIS M2RESEARCH
Outcome results
None listed