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

NCT04346797 | Unknown Phase 2 DMC

• 1 other identifier: APHP200375-4
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Survival without needs of intubation at day 14

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

  14 days

• 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

  3 days

Secondary Outcomes (14)

• Intubation free survival at day 14

  Day 14

• WHO progression scale at days 4, 7 and 14

  4, 7 and 14 days

• Survival at 14, 28 and 90 days

  14, 28 and 90 days

• Time to discharge

  90 days

• Time to oxygen supply independency

  90 days

Study Arms (2)

Eculizumab

EXPERIMENTAL

Eculizumab

Drug: Eculizumab

Standard of Care

NO INTERVENTION

Best standard of care

Interventions

Eculizumab 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

Eculizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Body weight ≥40 kg
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Réanimation médicale

Paris, 75010, France

RECRUITING

saint Louis

Paris, 75010, France

RECRUITING

Saint Louis

Paris, Île-de-France Region, 75010, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

eculizumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Régis Peffault de Latour, MD PhD

CONTACT

1 42 49 96 39; regis.peffaultdelatour@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Bayesian open labelled randomized clinical trial

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 15, 2020
• Study Start: April 16, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: April 27, 2020

Record last verified: 2020-04

Locations

FR (3)