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

NCT ID: NCT04345991

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-15
• Study Completion Date: 2021-05-28

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Transfusion of COVID-19 convalescent plasma

Intervention Type: DRUG

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

Control patients

Control patients will receive the best standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Etablissement Français du Sang

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karine LACOMBE, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

SMIT, Saint Antoine hospital

Paris, , France

Countries

France

References

Lacombe K, Hueso T, Porcher R, Mekinian A, Chiarabini T, Georgin-Lavialle S, Ader F, Saison J, Martin-Blondel G, De Castro N, Bonnet F, Cazanave C, Francois A, Morel P, Hermine O, Pourcher V, Michel M, Lescure X, Soussi N, Brun P, Pommeret F, Sellier P, Rousset S, Piroth L, Michot JM, Baron G, de Lamballerie X, Mariette X, Tharaux PL, Resche-Rigon M, Ravaud P, Simon T, Tiberghien P. Use of covid-19 convalescent plasma to treat patients admitted to hospital for covid-19 with or without underlying immunodeficiency: open label, randomised clinical trial. BMJ Med. 2023 Oct 27;2(1):e000427. doi: 10.1136/bmjmed-2022-000427. eCollection 2023.

Reference Type: RESULT

PMID: 37920150 (View on PubMed)

Other Identifiers

2020-001246-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

APHP200375-10

Identifier Type: -

Identifier Source: org_study_id