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

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ClinicalTrials.gov Identifier: NCT04346797
Recruitment Status : Unknown
Verified April 2020 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : April 15, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 COVID19 Drug: Eculizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Bayesian open labelled randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CORIMUNO19-ECU: Trial Evaluating Efficacy and Safety of Eculizumab (Soliris) in Patients With COVID-19 Infection, Nested in the CORIMUNO-19 Cohort
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Eculizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Eculizumab
Eculizumab
 Drug: 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
No Intervention: Standard of Care
Best standard of care


Outcome Measures
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Primary Outcome Measures :
  1. Survival without needs of intubation at day 14 [ Time Frame: 14 days ]
    Survival without needs of intubation, events considered are intubation or death

  2. Change in organ failure at day 3 [ Time Frame: 3 days ]
    Change in organ failure at day 3, defined by the relative variation in Sequential Organ Failure Assessment score


Secondary Outcome Measures :
  1. Intubation free survival at day 14 [ Time Frame: 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

  2. WHO progression scale at days 4, 7 and 14 [ Time Frame: 4, 7 and 14 days ]

    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


  3. Survival at 14, 28 and 90 days [ Time Frame: 14, 28 and 90 days ]
    Overall survival

  4. Time to discharge [ Time Frame: 90 days ]
    Time between inclusion and hospital discharge

  5. Time to oxygen supply independency [ Time Frame: 90 days ]
    Time between inclusion and oxygen supply independency

  6. Time to negative viral excretion [ Time Frame: 90 days ]
    Time between inclusion and negative viral excretion

  7. Incidence of secondary infections [ Time Frame: 90 days ]
    Incidence of secondary infections (acquired pneumonia)

  8. Vasopressor-free survival [ Time Frame: 90 days ]
    Vasopressor-free survival

  9. Ventilator-free survival [ Time Frame: 90 days ]
    Ventilator-free survival

  10. 28-day ventilator-free days [ Time Frame: 28 days ]
    Number of ventilator-free days alive up to day 28

  11. Incidence of dialysis [ Time Frame: 90 days ]
    Incidence of dialysis (renal replacement therapy)

  12. PaO2/FiO2 ratio [ Time Frame: days 4, 7, 14 ]
    PaO2/FiO2 ratio

  13. Rate of respiratory acidosis at day 4 [ Time Frame: 4 days ]
    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

  14. Time to ICU discharge [ Time Frame: 90 days ]
    Time to ICU discharge


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346797


Contacts
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Contact: Régis Peffault de Latour, MD PhD 1 42 49 96 39 ext +33 regis.peffaultdelatour@aphp.fr

Locations
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France
Saint Louis Recruiting
Paris, Ile De France, France, 75010
Contact: Anne Bergeron-Lafaurie, MD PhD    +33 1 42 49 41 66    anne.bergeron-lafaurie@aphp.fr   
Principal Investigator: Anne bergeron-Lafaurie, MD PhD         
Réanimation médicale Recruiting
Paris, France, 75010
Contact: Elie Azoulay, MD PhD         
saint Louis Recruiting
Paris, France, 75010
Contact: R Peffault de la Tour, MD    33(1)42494949      
Principal Investigator: Regis Peffault de la Tour, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04346797    
Other Study ID Numbers: APHP200375-4
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Eculizumab
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs