Informations générales (source: ClinicalTrials.gov)
Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients (CORIMUNO-19)
Observational
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mars 2020
décembre 2021
26 octobre 2024
The overall objective of the study is to determine which treatments (e.g. immune
modulator drugs) have the most favorable benefit-risk in adult patients hospitalized with
COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical
ventilation or critical pneumonia requiring mechanical ventilation.
The specific aims of this Covid19 cohort are to collect observational data at regular
intervals on an ongoing basis in order to embed a series of randomized controlled trials
evaluating a various set of interventions for patients with COVID-19 pneumonia. The study
has a cohort multiple Randomized Controlled Trials (cmRCT) design.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Jean-Marie MICHOT | 21/06/2024 07:03:11 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| HOPITAL FOCH | jeudi 19 juin 2025 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hegp Aphp - Paris - Ile De France - France | Contact (sur clinicalTrials) | ||||
| Kremlin Bictre APHP - Le Kremlin-Bicêtre - Ile De France - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial
or public health assay in any specimen < 72 hours and/or CT Scan prior to
randomization (Following typical radiological findings (ground glass abnormalities,
and absence of lymphadenopathy, pleural effusion, pulmonary nodules, lung
cavitation)
- Hospitalized patients
- Illness of any duration and severity (mild, moderate, severe, critical, see annexe
1), with symptoms (fever, cough, respiratory difficulties, shortness of breath), and
at least one of the following:
- Radiographic infiltrates by imaging (CT scan)
- Clinical assessment (evidence of rales/crackles on exam or respiratory rate >25/min)
AND SpO2≤94% on room air
- SpO2≤97 % with O2 > 5L/min or Respiratory rate>=30/min
- Requiring mechanical ventilation
- With any comorbidities (TBD such as acute kidney injury, cardiovascular condition,
pulmonary disease, obesity, high blood pressure, diabetes, chronic kidney diseases,
haematological diseases, sickle cell diseases, autoimmune and auto-inflammatory,
pregnant women, HIV infected, etc)
- Male or female adult ≥ 18 years of age at time of enrolment
- Patients must be able and willing to comply with study visits and procedures.
- Patient agrees to the collection of oropharyngeal and nasal swabs and venous blood
per protocol Written informed consent provided by the patient or alternatively by
next-of-kin prior to any protocol-specific procedures.
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial
or public health assay in any specimen < 72 hours and/or CT Scan prior to
randomization (Following typical radiological findings (ground glass abnormalities,
and absence of lymphadenopathy, pleural effusion, pulmonary nodules, lung
cavitation)
- Hospitalized patients
- Illness of any duration and severity (mild, moderate, severe, critical, see annexe
1), with symptoms (fever, cough, respiratory difficulties, shortness of breath), and
at least one of the following:
- Radiographic infiltrates by imaging (CT scan)
- Clinical assessment (evidence of rales/crackles on exam or respiratory rate >25/min)
AND SpO2≤94% on room air
- SpO2≤97 % with O2 > 5L/min or Respiratory rate>=30/min
- Requiring mechanical ventilation
- With any comorbidities (TBD such as acute kidney injury, cardiovascular condition,
pulmonary disease, obesity, high blood pressure, diabetes, chronic kidney diseases,
haematological diseases, sickle cell diseases, autoimmune and auto-inflammatory,
pregnant women, HIV infected, etc)
- Male or female adult ≥ 18 years of age at time of enrolment
- Patients must be able and willing to comply with study visits and procedures.
- Patient agrees to the collection of oropharyngeal and nasal swabs and venous blood
per protocol Written informed consent provided by the patient or alternatively by
next-of-kin prior to any protocol-specific procedures.
- Patients with any condition that the physician judges could be detrimental to the
patient participating in this study; including any clinically important deviations
from normal clinical laboratory values or concurrent medical conditions (active
infection diseases such as severe bacterial infections, aspergillosis, tuberculosis,
depending on the tested medication).
- Absence of Health Insurance
- Subject protected by law under guardianship or curatorship