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| Name | Class |
|---|---|
| Innate Pharma | INDUSTRY |
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The primary objective of this trial is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (ARDS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| avdoralimab | Experimental | Biological/Vaccine: avdoralimab intravenous administration of avdoralimab Other Names: • IPH5401 |
|
| Placebo | Placebo Comparator | intravenous administration of Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| avdoralimab | Biological | intravenous administration of avdoralimab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement using WHO ordinal scale | improvement of WHO ordinal scale | day 28 |
| Number of ventilator-free days at Day 28 (VFD28) | Number of days without mechanical ventilation at Day 28 for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) Patients hospitalized in ICU | day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emilie Garrido-Pradalie | Assistance Publique Hôpitaux de Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Marseille | Marseille | 13354 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36218354 | Derived | Carvelli J, Meziani F, Dellamonica J, Cordier PY, Allardet-Servent J, Fraisse M, Velly L, Barbar SD, Lehingue S, Guervilly C, Desgrouas M, Camou F, Piperoglou C, Vely F, Demaria O, Karakunnel J, Fares J, Batista L, Rotolo F, Viotti J, Boyer-Chammard A, Lacombe K, Le Dault E, Carles M, Schleinitz N, Vivier E; FOR COVID Elimination (FORCE) Study Group. Avdoralimab (Anti-C5aR1 mAb) Versus Placebo in Patients With Severe COVID-19: Results From a Randomized Controlled Trial (FOR COVID Elimination [FORCE]). Crit Care Med. 2022 Dec 1;50(12):1788-1798. doi: 10.1097/CCM.0000000000005683. Epub 2022 Oct 10. | |
| 34473343 |
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| ID | Term |
|---|---|
| C000711668 | avdoralimab |
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Parallel Assignment
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Double (Participant, Investigator)
| Placebo | Other | intravenous administration of placebo |
|
| Derived |
| Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |