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

NCT04345991 | Completed Phase 2 DMC

• 2 other identifiers: APHP200375-102020-001246-18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

COVID 19; Convalescent plasma

Outcome Measures

Primary Outcomes (2)

• Survival without needs of ventilator utilization or use of immunomodulatory drugs (other than steroids)

  Survival without needs of ventilator utilization (including non- invasive ventilation, NIV) or use of immunomodulatory drugs at day 14 of randomization (WHO score \< 6) or additional immunomodulatory treatment (other than steroids). Thus, events considered are the need of ventilator use (including non invasive ventilation, NIV, or use of immunomodulatory drugs), or death.

  At day 14 after randomization

• WHO progression scale ≥6

  WHO progression scale ≥6 at day 4 of randomization

  at day 4 of randomization

Secondary Outcomes (7)

• Severe adverse events

  up to 28 days

• WHO progression scale

  at 4, 7 and 14 days after randomization

• Overall survival

  at 14 and 28 days after randomization

• Time from randomization to discharge

  Time until discharge up to 28 days

• Time to oxygen supply independency

  Time until oxygen supply independency up to 28 days

Study Arms (2)

COVID-19 convalescent plasma

EXPERIMENTAL

A plasma unit provided by a COVID-19 convalescent pathogen-reduced plasma will be used for the treatment of the patients.

Drug: Transfusion of COVID-19 convalescent plasma

Control patients

NO INTERVENTION

Control patients will receive the best standard of care

Interventions

Transfusion of COVID-19 convalescent plasma 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

COVID-19 convalescent plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Current documented and uncontrolled bacterial infection.
• Prior severe (grade 3) allergic reactions to plasma transfusion

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Etablissement Français du Sang: collaborator

Study Sites (1)

SMIT, Saint Antoine hospital

Paris, 75012, France

Location

Related Publications (1)

• 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.

  PMID: 37920150 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Karine LACOMBE, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 15, 2020
• Study Start: April 15, 2020
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

FR (1)