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Efficacy of Convalescent Plasma to Treat COVID-19 Patients, a Nested Trial in the CORIMUNO-19 Cohort (CORIPLASM)

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ClinicalTrials.gov Identifier: NCT04345991
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
Etablissement Français du Sang
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE April 10, 2020
First Posted Date  ICMJE April 15, 2020
Last Update Posted Date May 20, 2020
Actual Study Start Date  ICMJE April 15, 2020
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • Survival without needs of ventilator utilization or use of immunomodulatory drugs [ Time Frame: At day 14 after randomization ]
    Survival without needs of ventilator utilization (including non- invasive ventilation, NIV) or use of immunomodulatory drugs at day 14 of randomization (WHO score < 6). Thus, events considered are the need of ventilator use (including non invasive ventilation, NIV, or use of immunomodulatory drugs), or death.
  • WHO progression scale ≥6 [ Time Frame: at day 4 of randomization ]
    WHO progression scale ≥6 at day 4 of randomization
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • Severe adverse events [ Time Frame: up to 28 days ]
    Occurrence of severe adverse events known to be associated with plasma transfusion such as transfusion associated circulatory overload (TACO), transfusion related acute lung injury (TRALI), and severe allergy will be reported. Occurrence of systemic and/or local (lungs) inflammation associated with convalescent plasma transfusion will also be reported.
  • WHO progression scale [ Time Frame: at 4, 7 and 14 days after randomization ]
    WHO progression scale at 4, 7 and 14 days after randomization (from stage 4-5 to stage 6 to 10) 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
  • Overall survival [ Time Frame: at 14 and 28 days after randomization ]
  • Time from randomization to discharge [ Time Frame: Time until discharge up to 28 days ]
  • Time to oxygen supply independency [ Time Frame: Time until oxygen supply independency up to 28 days ]
  • Survival without needs of ventilator utilization [ Time Frame: At day 14 after randomization ]
    Survival without needs of ventilator utilization (including non- invasive ventilation, NIV) at day 14 of randomization (WHO score < 6). Thus, events considered are the need of ventilator use (including non invasive ventilation, NIV), or death.
  • Survival without use of immunomodulatory drugs [ Time Frame: At day 14 after randomization ]
    Survival without use of immunomodulatory drugs at day 14 of randomization (WHO score < 6). Thus, events considered are use of immunomodulatory drugs, or death.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Convalescent Plasma to Treat COVID-19 Patients, a Nested Trial in the CORIMUNO-19 Cohort
Official Title  ICMJE Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - CORIMUNO-CORIPLASM : EFFICACY OF CONVALESCENT PLASMA TO TREAT SARS-COV2 INFECTED PATIENTS
Brief Summary

The coronavirus disease 2019 (COVID-19) viral pneumonia is now a worldwide pandemic caused by the Severe acute respiratory virus coronavirus 2 (SARS-CoV-2). The number of cases, and associated mortality has increased dramatically since the first cases in Wuhan, China in December 2019 . To date, no specific treatment has been proven to be effective for COVID-19. Treatment is currently mainly supportive, with in particular mechanical ventilation for the critically ill patients (6.1% in a series of 1099 cases in China). Novel therapeutic approaches are in acute need. In this context, the therapeutic potential associated with convalescent plasma needs to be explored.

The objective of COVIPLASM trial (a nested trial in the CORIMUNO-19 COHORT) is to study the efficacy of convalescent plasma to treat SARS-COV2 infected patients.

Detailed Description

Hypothesize: early administration of convalescent plasma containing polyclonal neutralizing Abs may inhibit viral entry and replication (as recently suggested in vitro) and consequently blunt an early pro-inflammatory pathogenic endogenous Ab response.

Potential donors of convalescent plasma will be identified through various means, including hospitals taking care of such patient, practitioners treating outpatients or specific social messaging. Convalescent patients at least 14 to 28 days (per at date regulation regarding blood donation) after the symptoms resolution will be invited to undergo plasma apheresis, pending general eligibility such as an age between 18 and 65 years old and weight not less than 50 kg.

Two convalescent plasma units of 200 to 220 ml each will be transfused i.v. as early as possible and no later than 10 days after onset of clinical symptoms. In the absence of acute unforeseen adverse events in the first 3 patients, an additional 2 plasma units of 200/220 ml each will be transfused 24 hours after first 2 units: a total of 4 units / patient. Transfusion monitoring, treatment and reporting of adverse events will be performed per ANSM hemovigilance regulation regarding transfusion of labile blood products as well as through the specific clinical trial vigilance.

An average of 120 participants will be expected (60 participants in each arm). Availability of ABO compatible plasma will be checked by investigator when a Corimmuno patients is eligible. If so, randomization will be undertaken and patient will be offered to participate in this nested trial if he is allocated to the experimental arm.

An interim analysis is performed at mid-trial, but inclusions are not frozen to wait for the interim analysis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE Drug: Transfusion of COVID-19 convalescent plasma
Two convalescent plasma units of 200 to 220 ml each will be transfused i.v. as early as possible and no later than 10 days after onset of clinical symptoms. In the absence of acute unforeseen adverse events in the first 3 patients, an additional 2 plasma units of 200/220 ml each will be transfused 24 hours after first 2 units: a total of 4 units / patient
Study Arms  ICMJE
  • Experimental: COVID-19 convalescent plasma
    A plasma unit provided by a COVID-19 convalescent pathogen-reduced plasma will be used for the treatment of the patients.
    Intervention: Drug: Transfusion of COVID-19 convalescent plasma
  • No Intervention: Control patients
    Control patients will receive the best standard of care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients included in the CORIMUNO-19 cohort
  • Onset of COVID19 functional signs <8 days (plasma transfusion may occur up to day 10 of onset)
  • Mild severity as described in the WHO scale

Exclusion Criteria:

  • Pregnancy
  • Current documented and uncontrolled bacterial infection.
  • Prior severe (grade 3) allergic reactions to plasma transfusion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karine LACOMBE, PU-PH +33 149283196 karine.lacombe2@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04345991
Other Study ID Numbers  ICMJE APHP200375-10
2020-001246-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Etablissement Français du Sang
Investigators  ICMJE
Principal Investigator: Karine LACOMBE, PU-PH Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP