Status:
UNKNOWN
CORIMUNO19-ECU: Trial Evaluating Efficacy and Safety of Eculizumab (Soliris) in Patients With COVID-19 Infection, Nested in the CORIMUNO-19 Cohort
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
SARS-CoV-2
COVID19
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 dise...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
April 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04346797
Start Date
April 16 2020
End Date
December 31 2020
Last Update
April 27 2020
Active Locations (3)
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1
Réanimation médicale
Paris, France, 75010
2
saint Louis
Paris, France, 75010
3
Saint Louis
Paris, Île-de-France Region, France, 75010