A double-blind, randomized study versus placebo of avdoralimab (IPH5401), an anti-C5aR antibody, in patients with COVID-19 induced pneumonia - FORCE (FOR COVID-19 Elimination)

ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE0 个研究点目标入组 168 人开始时间: 2020年4月14日最近更新: 2020年9月28日

适应症

试验速览

暂无简介。

•*patient over 18 years of age
•*Patient under 80 years of age
•*COVID-19 hypoxemic pneumonia (cohort 1)defined by :
•o Need for oxygen therapy = 5 l/min to maintain SpO2 > 93%(conventional oxygen therapy and / or high flow oxygen therapy)
•o PCR SARS-CoV-2 positive
•*For patients immediately included in intensive care : (cohort 2)
•o Patient under mechanical invasive ventilation with a PaO2/FiO2 ratio < 300 for more than 24 hours.
•o PCR SARS-CoV-2 positive and / or chest scanner in favor of the diagnosis of COVID-19
•Pour les patients inclus d’emblée en réanimation (cohort3):
•-Patient sous ventilation mécanique invasive depuis moins de 72h et avec un rapport PaO2/FiO2 inférieur ou égal à 200 et supérieur ou égal à 60 au moment de la randomisation
•-PCR SARS-CoV-2 positive
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 84
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 84

•-Pregnant or breastfeeding woman
•-Patient deprived of liberty
•-Patient refusal to participate in the study
•-Patient already included in another clinical trial or within 2 weeks prior to randomization
•-Patient for whom measures of therapeutic limitations have been issued for non-admission to intensive care units
•- Uncontrolled sepsis of bacterial or fungal origin
•Additional non-inclusion criteria for cohort 1:
•- Patients who have already been treated with high flow oxygen therapy and / or non-invasive ventilation if the patient is included on conventional oxygen therapy
•- Patient who received invasive mechanical ventilation prior to randomization
•Additional non-inclusion criteria for cohort 3:
•- Patients under invasive mechanical ventilation for more than 72 hours
•- Patients on ECMO at the time of randomization
•Additional non-inclusion criteria for cohorts 1 and 3
•-Treatment with chloroquine or hydroxychloroquine at the time of randomization
•- Patient decompensating a chronic pulmonary pathology: asthma, COPD, cystic fibrosis
•- Chronic dialysis patients or justifying extra-renal purification at the time of randomization
•- Organ transplants within 3 months prior to randomization
•- Patient with NYHA stage III-IV chronic congestive heart failure
•- Cirrhotic patients Child B-C
•- Patients who presented with cardiac arrest within 2 weeks prior to randomization

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