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

NCT ID: NCT04346797

Last Updated: 2020-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-16
• Study Completion Date: 2020-12-31

Brief 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). 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eculizumab

Eculizumab

Group Type: EXPERIMENTAL

Eculizumab

Intervention Type: DRUG

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

Standard of Care

Best standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Eculizumab

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients between 18 and 675 years old included in the CORIMUNO-19 cohort

2. 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.

• Respiratory failure and requiring mechanical ventilation
• Vasopressive support

3. 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.

4. 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Réanimation médicale

Paris, , France

Site Status: RECRUITING

saint Louis

Paris, , France

Site Status: RECRUITING

Saint Louis

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Régis Peffault de Latour, MD PhD

Role: CONTACT

regis.peffaultdelatour@aphp.fr

1 42 49 96 39 ext. +33

Facility Contacts

Elie Azoulay, MD PhD

Role: primary

R Peffault de la Tour, MD

Role: primary

33(1)42494949

Anne Bergeron-Lafaurie, MD PhD

Role: primary

anne.bergeron-lafaurie@aphp.fr

+33 1 42 49 41 66

Other Identifiers

APHP200375-4

Identifier Type: -

Identifier Source: org_study_id