Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).
NCT05010876 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2022-12-22
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.
Conditions
- Covid19
Interventions
- DRUG
-
C1 Inhibitor Human
standard care + 1000 units of C1 inhibitor during 2 slow infusions of 500 units
- DRUG
-
Icatibant Injection
a single injection of 30 mg subcutaneously
- OTHER
-
Placebo
The placebo will be physiological serum presented in forms mimicking the C1-Inhibitor and the icatibant.
Sponsors & Collaborators
-
GCS Ramsay Santé pour l'Enseignement et la Recherche
lead OTHER
Principal Investigators
-
Denis VINCENT, MD PD · Médecine interne, Faculté de Montpellier
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-04
- Primary Completion
- 2021-06-13
- Completion
- 2021-06-21
Countries
- France
Study Locations
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