Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients

Corona Virus Infection Clinical Trial

— CORIMUNO-19  

Official title:

Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04324047
• Other study ID #: APHP200375
• Secondary ID: 2020-001246-18
• Status: Recruiting
• Start date: March 27, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Olivier HERMINE, MD-PhD
• Phone: 603707920
• Email: ohermine[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2021
• Est. primary completion date: March 27, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Severe Acute Respiratory Syndrome
• Virus Diseases

Locations

Country	Name	City	State
France	Kremlin Bictre APHP	Le Kremlin-Bicêtre	Ile De France
France	Cochin Aphp	Paris	Ile De France
France	Hegp Aphp	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Overall Survival	14 days
Primary	WHO progression scale COVID 19	Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10	14 days