Status:
UNKNOWN
Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Corona Virus Infection
Eligibility:
All Genders
18+ years
Brief Summary
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04324047
Start Date
March 27 2020
End Date
December 31 2021
Last Update
April 1 2020
Active Locations (3)
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1
Kremlin Bictre APHP
Le Kremlin-Bicêtre, Île-de-France Region, France
2
Cochin Aphp
Paris, Île-de-France Region, France
3
Hegp Aphp
Paris, Île-de-France Region, France