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

A

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed
Phase 2

Conditions

Covid19

Treatments

Drug: Transfusion of COVID-19 convalescent plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT04345991
2020-001246-18 (EudraCT Number)
APHP200375-10

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

COVID-19 convalescent plasma
Experimental group
Description:
A plasma unit provided by a COVID-19 convalescent pathogen-reduced plasma will be used for the treatment of the patients.
Treatment:
Drug: Transfusion of COVID-19 convalescent plasma
Control patients
No Intervention group
Description:
Control patients will receive the best standard of care

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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