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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05010876
Study type Interventional
Source GCS Ramsay Santé pour l'Enseignement et la Recherche
Contact
Status Completed
Phase Phase 2
Start date February 4, 2021
Completion date June 21, 2021

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