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

Covid19 Clinical Trial

— AntagoBrad  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05010876
• Other study ID #: 2020-002225-29
• Status: Completed
• Phase: Phase 2
• Start date: February 4, 2021
• Est. completion date: June 21, 2021

Study information

• Verified date: August 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 21, 2021
• Est. primary completion date: June 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• C1 Inhibitor Human
standard care + 1000 units of C1 inhibitor during 2 slow infusions of 500 units
• 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.

Locations

Country	Name	City	State
France	Hôpital Privé de Parly II	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy evaluation respiratory discomfort	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.; The evaluation of the treatment efficacy of the study is based on the clinical monitoring of the patient and particularly on the following combination of criteria as experienced by the patient : no respiratory discomfort; heart rate between 60 and 90 /min; respiratory rate less than 20/min; O2 saturation greater than 94% without oxygen supply	96 hours after the administration of treatment
Primary	Efficacy evaluation heart rate between 60 and 90 /min	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.; The evaluation of the treatment efficacy of the study is based on the clinical monitoring of the patient and particularly on the following combination of criteria as experienced by the patient : no respiratory discomfort; heart rate between 60 and 90 /min; respiratory rate less than 20/min; O2 saturation greater than 94% without oxygen supply	96 hours after the administration of treatment
Primary	Efficacy evaluation respiratory rate less than 20/min	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.; The evaluation of the treatment efficacy of the study is based on the clinical monitoring of the patient and particularly on the following combination of criteria as experienced by the patient : no respiratory discomfort; heart rate between 60 and 90 /min; respiratory rate less than 20/min; O2 saturation greater than 94% without oxygen supply	96 hours after the administration of treatment
Primary	Efficacy evaluation O2 saturation greater than 94% without oxygen supply	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.; The evaluation of the treatment efficacy of the study is based on the clinical monitoring of the patient and particularly on the following combination of criteria as experienced by the patient : no respiratory discomfort; heart rate between 60 and 90 /min; respiratory rate less than 20/min; O2 saturation greater than 94% without oxygen supply	96 hours after the administration of treatment
Secondary	Tolerance evaluation	The tolerance of the study products will be assessed by collecting adverse events that occurred during the study period.	Day 10