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.
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.
Exclusion Criteria:
- 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
Kremlin Bictre APHP
Le Kremlin-Bicêtre, Ile De France, France
Cochin Aphp
Paris, Ile De France, France
Hegp Aphp
Paris, Ile De France, France
Olivier HERMINE, MD-PhD
603707920 - +33
ohermine@gmail.com
Matthieu RESCHE-RIGON, MD PhD
685740240 - +33
matthieu.resche-rigon@u-paris.fr