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

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.

Study Overview

• Status: Unknown
• Conditions: Corona Virus Infection

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Le Kremlin-Bicêtre, Ile De France, France
      • Recruiting
      • Kremlin Bictre APHP
    • Paris, Ile De France, France
      • Recruiting
      • Cochin Aphp
    • Paris, Ile De France, France
      • Recruiting
      • Hegp Aphp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All adult patients with laboratory-confirmed SARS-CoV-2 infection

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Overall Survival	14 days
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
• Dal-Re R. COVID-19 drug research and the cohort multiple randomised controlled trial design. Eur Respir J. 2022 Sep 15;60(3):2200746. doi: 10.1183/13993003.00746-2022. Print 2022 Sep.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2020
• Primary Completion (Anticipated): March 27, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: APHP200375; 2020-001246-18 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No