AzTrials
AzTrials

SARS-CoV-2Phase 2CORIMUNO19-ECUNCT04346797

CORIMUNO19-ECU: Trial Evaluating Efficacy and Safety of Eculizumab (Soliris) in Patients With COVID-19 Infection, Nested in the CORIMUNO-19 Cohort

A Phase 2 study testing Eculizumab in people with SARS-CoV-2 and COVID19, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The overall objective of the study is to determine the therapeutic effect and tolerance of Eculizumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
SARS-CoV-2, COVID19
What is being tested?
Eculizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesFrance
Study dates
16 Apr 2020to 31 Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients between 18 and 675 years old included in the CORIMUNO-19 cohort
  • Patients belonging to one of the 2 following groups
  • Group 1: 60 patients not requiring ICU at admission with moderate and severe pneumopathy according to the WHO Criteria of severity of COVID pneumopathy, meeting all of the 2 following criteria:
  • Respiratory symptoms with radiological findings of pneumonia
  • Severe pneumonia requiring ≥ 5L/min of oxygen to maintain SpO2 >97%
  • Group 2: 60 patients requiring ICU based on Criteria of severity of COVID pneumopathy.
Show all 12Show fewer
  • Respiratory failure and requiring mechanical ventilation
  • Vasopressive support
  • Vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating Eculizumab to reduce the risk of meningococcal infection (N meningitidis) [(Bexsero® (2 injections with a minimum of 1 month interval) + Menveo@ or Niminrex® ) and daily antibiotics (Oracilline®)]. If vaccination cannot be confirmed or if the patient cannot receive it, the participant should receive prophylactic antibiotics against meningococcal infection prior to initiating Eculizumab treatment and for at least 3 months from the last infusion of Eculizumab.
  • Female patients of childbearing potential and male patients with female partners of childbearing potential must follow protocol-specified guidance for avoiding pregnancy while on treatment and for 8 months after last dose of Eculizumab.
  • 5- Body weight ≥40 kg
  • 6-Patient and/or alternatively by next-of-kin must be willing and able to give written informed consent according to the applicable regulations including emergency and intensive care contexts

Who cannot join

  • Patients with exclusion criteria to the CORIMUNO-19 cohort.
  • Age ≥ 70 years
  • Pregnancy or lactation
  • History or unresolved Neisseria meningiditis infection
  • Ongoing sepsis, presence or suspicion of active and untreated systemic bacterial infection prior study screening and untreated with antibiotics,
  • Hypersensitivity to any ingredient contained in Eculizumab, including hypersensitivity to murine proteins.

Trial locations and contacts

3 sites in 1 country.

Régis Peffault de Latour, MD PhD contact

1 42 49 96 39 ext. +33

regis.peffaultdelatour@aphp.fr

France3 sites, 3 recruiting

  • Réanimation médicale

    Paris, 75010

    Elie Azoulay, MD PhD

    Recruiting

  • saint Louis

    Paris, 75010

    R Peffault de la Tour, MD, 33(1)42494949

    Regis Peffault de la Tour, MD

    Recruiting

  • Saint Louis

    Paris, Île-de-France Region, 75010

    Anne Bergeron-Lafaurie, MD PhD, +33 1 42 49 41 66, anne.bergeron-lafaurie@aphp.fr

    Anne bergeron-Lafaurie, MD PhD

    Recruiting

Other trials in France

About this study

The overall objective of the study is to determine the therapeutic effect and tolerance of Eculizumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Eculizumab is a terminal complement inhibitor that has been investigated for more than 10 years in numerous complement-mediated diseases. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Eculizumab administration to patients enrolled in the CORIMUNO-19 cohort. Eculizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Eculizumab will receive standard of care. Outcomes of Eculizumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.

Conditions
SARS-CoV-2, COVID19
Being tested
Eculizumab
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EculizumabDrug

    Intravenous administration as follows:

    Induction dosage regimen at 1200 mg on Days 1, 4, 8 then 1200 mg or 900 mg on Day 12 depending on the monitoring of Eculizumab Plasma Level and CH5O and sC5B9 and maintenance doses of 900 mg on Days 15, 18 and 22

Study groups in NCT04346797
Study groupRoleWhat they receive
EculizumabExperimentalEculizumab
Receives: Drug: Eculizumab
Standard of CareNo interventionBest standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival without needs of intubation at day 14

    Survival without needs of intubation, events considered are intubation or death

    Measured: 14 days

  2. Change in organ failure at day 3

    Change in organ failure at day 3, defined by the relative variation in Sequential Organ Failure Assessment score

    Measured: 3 days

Secondary outcomes (14)

  1. Intubation free survival at day 14

    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

    Measured: Day 14

  2. WHO progression scale at days 4, 7 and 14

    WHO progression scale:

    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

    Measured: 4, 7 and 14 days

  3. Survival at 14, 28 and 90 days

    Overall survival

    Measured: 14, 28 and 90 days

  4. Time to discharge

    Time between inclusion and hospital discharge

    Measured: 90 days

  5. Time to oxygen supply independency

    Time between inclusion and oxygen supply independency

    Measured: 90 days

  6. Time to negative viral excretion

    Time between inclusion and negative viral excretion

    Measured: 90 days

  7. Incidence of secondary infections

    Incidence of secondary infections (acquired pneumonia)

    Measured: 90 days

  8. Vasopressor-free survival

    Vasopressor-free survival

    Measured: 90 days

  9. Ventilator-free survival

    Ventilator-free survival

    Measured: 90 days

  10. 28-day ventilator-free days

    Number of ventilator-free days alive up to day 28

    Measured: 28 days

  11. Incidence of dialysis

    Incidence of dialysis (renal replacement therapy)

    Measured: 90 days

  12. PaO2/FiO2 ratio

    PaO2/FiO2 ratio

    Measured: days 4, 7, 14

  13. Rate of respiratory acidosis at day 4

    Number of patients with arterial blood pH of <7.25, with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours

    Measured: 4 days

  14. Time to ICU discharge

    Time to ICU discharge

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2020
  2. Study start16 Apr 2020
  3. Primary completion30 Sep 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Bayesian open labelled randomized clinical trial
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04346797
Sponsor's protocol ID
APHP200375-4
Acronym
CORIMUNO19-ECU
Status last verified
Apr 2020
First submitted
6 Apr 2020
Last updated
27 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eculizumab in people with SARS-CoV-2 and COVID19, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Régis Peffault de Latour, MD PhD (1 42 49 96 39 ext. +33, regis.peffaultdelatour@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival without needs of intubation at day 14 (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04346797.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in