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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.
Prospective, prospective, multicentre, double-blind, randomised, multi-centre study of three parallel groups of patients:
The study has two parts:
The maximum duration of patient participation in the study will be 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard care + C1 inhibitor | Experimental | 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. |
|
| standard care + Icatibant + C1 inhibitor | Experimental | 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. |
|
| standard care + placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C1 Inhibitor Human | Drug | standard care + 1000 units of C1 inhibitor during 2 slow infusions of 500 units |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 :
| 96 hours after the administration of treatment |
| 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 :
| 96 hours after the administration of treatment |
| 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 :
| 96 hours after the administration of treatment |
| Efficacy evaluation O2 saturation greater than 94% without oxygen supply |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance evaluation | The tolerance of the study products will be assessed by collecting adverse events that occurred during the study period. | Day 10 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Denis VINCENT, MD PD | Médecine interne, Faculté de Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé de Parly II | Le Chesnay | 78150 | France |
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Prospective, randomized, double-blind, multicentre, prospective study of three parallel groups of patients.
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Double blind
| Icatibant Injection | Drug | a single injection of 30 mg subcutaneously |
|
| Placebo | Other | The placebo will be physiological serum presented in forms mimicking the C1-Inhibitor and the icatibant. |
|
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 :
| 96 hours after the administration of treatment |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D050718 | Complement C1 Inhibitor Protein |
| C065679 | icatibant |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D003174 | Complement C1 Inactivator Proteins |
| D015843 | Serpins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003169 | Complement Inactivator Proteins |
| D003165 | Complement System Proteins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
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