Clinical trial NCT05010876: Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).
Official title: Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, double-blind, multicentre, prospective study of three parallel groups of patients.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Efficacy evaluation respiratory discomfort
timeFrame: 96 hours after the administration of treatment
measure: Efficacy evaluation heart rate between 60 and 90 /min
timeFrame: 96 hours after the administration of treatment
measure: Efficacy evaluation respiratory rate less than 20/min
timeFrame: 96 hours after the administration of treatment
measure: Efficacy evaluation O2 saturation greater than 94% without oxygen supply
timeFrame: 96 hours after the administration of treatment
Secondary outcomes:
measure: Tolerance evaluation
timeFrame: Day 10
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Hôpital Privé de Parly II
Study officials:
affiliation: Médecine interne, Faculté de Montpellier
name: Denis VINCENT, MD PD
role: STUDY_DIRECTOR
References: