Back to resultsEvaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study). (AntagoBrad)
Primary Purpose
Covid19
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
C1 Inhibitor Human
Icatibant Injection
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
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
Sites / Locations
- Hôpital Privé de Parly II
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
standard care + C1 inhibitor
standard care + Icatibant + C1 inhibitor
standard care + placebo
Arm Description
The C1 inhibitor will be used at a dose of 1000 units per slow infusion (two hours). Two infusions will be given 24 hours apart. These doses correspond to the usual doses used in the treatment of conditions in which the C1-Inhibitor is indicated.
The C1 inhibitor will be used at a dose of 1000 units per slow infusion (two hours). Two infusions will be given 24 hours apart. These doses correspond to the usual doses used in the treatment of conditions in which the C1-Inhibitor is indicated. The icatibant will be used in a single injection of 30 mg subcutaneously, preferably in the abdominal region. These doses correspond to the doses usually used in the treatment of conditions in which icatibant is indicated.
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Tolerance evaluation
The tolerance of the study products will be assessed by collecting adverse events that occurred during the study period.
Full Information
NCT ID
NCT05010876
First Posted
August 16, 2021
Last Updated
December 20, 2022
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT05010876
Brief Title
Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).
Acronym
AntagoBrad
Official Title
Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 4, 2021 (Actual)
Primary Completion Date
June 13, 2021 (Actual)
Study Completion Date
June 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, double-blind, multicentre, prospective study of three parallel groups of patients.
Masking
ParticipantInvestigator
Masking Description
Double blind
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard care + C1 inhibitor
Arm Type
Experimental
Arm Description
The C1 inhibitor will be used at a dose of 1000 units per slow infusion (two hours). Two infusions will be given 24 hours apart. These doses correspond to the usual doses used in the treatment of conditions in which the C1-Inhibitor is indicated.
Arm Title
standard care + Icatibant + C1 inhibitor
Arm Type
Experimental
Arm Description
The C1 inhibitor will be used at a dose of 1000 units per slow infusion (two hours). Two infusions will be given 24 hours apart. These doses correspond to the usual doses used in the treatment of conditions in which the C1-Inhibitor is indicated.
The icatibant will be used in a single injection of 30 mg subcutaneously, preferably in the abdominal region. These doses correspond to the doses usually used in the treatment of conditions in which icatibant is indicated.
Arm Title
standard care + placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
C1 Inhibitor Human
Intervention Description
standard care + 1000 units of C1 inhibitor during 2 slow infusions of 500 units
Intervention Type
Drug
Intervention Name(s)
Icatibant Injection
Intervention Description
a single injection of 30 mg subcutaneously
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo will be physiological serum presented in forms mimicking the C1-Inhibitor and the icatibant.
Primary Outcome Measure Information:
Title
Efficacy evaluation respiratory discomfort
Description
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
Time Frame
96 hours after the administration of treatment
Title
Efficacy evaluation heart rate between 60 and 90 /min
Description
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
Time Frame
96 hours after the administration of treatment
Title
Efficacy evaluation respiratory rate less than 20/min
Description
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
Time Frame
96 hours after the administration of treatment
Title
Efficacy evaluation O2 saturation greater than 94% without oxygen supply
Description
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
Time Frame
96 hours after the administration of treatment
Secondary Outcome Measure Information:
Title
Tolerance evaluation
Description
The tolerance of the study products will be assessed by collecting adverse events that occurred during the study period.
Time Frame
Day 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis VINCENT, MD PD
Organizational Affiliation
Médecine interne, Faculté de Montpellier
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Privé de Parly II
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).
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