NCT05010876

Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-04
• Primary completion: 2021-06-13
• Completion: 2021-06-21
• First posted: 2021-08-18
• Last updated: 2022-12-22

Locations

1 site across 1 country: France