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.
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.
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
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
SMIT, Saint Antoine hospital
Paris, France
Karine LACOMBE, PU-PH, Principal Investigator
Assistance Publique - Hôpitaux de Paris