CClinicalTrials.gg
Status unknownNCT04324047CORIMUNO-19Updated Apr 1, 2020

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

An observational study in Corona Virus Infection, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-01.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Corona Virus Infection
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In context

Coronavirus Infections

929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 300 across 334 observational studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Survival

    Overall Survival

    Time frame: 14 days

  2. 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

    Time frame: 14 days

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Study locations

3 of 3 sites recruiting
  • Kremlin Bictre APHP
    Le Kremlin-Bicêtre, Ile De France, France
    Recruiting
  • Cochin Aphp
    Paris, Ile De France, France
    Recruiting
  • Hegp Aphp
    Paris, Ile De France, France
    Recruiting
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References and documents

Publications

  • 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. PubMed 35896204 ↗
  • 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. PubMed 34473343 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04324047
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Mar 27, 2020
Start date
Mar 27, 2020
Primary completion
Mar 27, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Apr 1, 2020

Study contacts

Olivier HERMINE, MD-PhD
Contact
ohermine@gmail.com
603707920 ext. +33
Matthieu RESCHE-RIGON, MD PhD
Contact
matthieu.resche-rigon@u-paris.fr
685740240 ext. +33

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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