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Covid19Phase 2CORIPLASMNCT04345991

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

A Phase 2 study testing Transfusion of COVID-19 convalescent plasma in people with Covid19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Transfusion of COVID-19 convalescent plasma
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteFrance
Study dates
15 Apr 2020to 28 May 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • SMIT, Saint Antoine hospital

    Paris, 75012

Other trials in France

About this study

Official title: 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

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.

Read the 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
Being tested
Transfusion of COVID-19 convalescent plasma
Keywords
COVID 19, Convalescent plasma
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transfusion of COVID-19 convalescent plasmaDrug

    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 groups in NCT04345991
Study groupRoleWhat they receive
COVID-19 convalescent plasmaExperimentalA plasma unit provided by a COVID-19 convalescent pathogen-reduced plasma will be used for the treatment of the patients.
Receives: Drug: Transfusion of COVID-19 convalescent plasma
Control patientsNo interventionControl patients will receive the best standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At day 14 after randomization

  2. WHO progression scale ≥6

    WHO progression scale ≥6 at day 4 of randomization

    Measured: at day 4 of randomization

Secondary outcomes (7)

  1. Severe adverse events

    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.

    Measured: up to 28 days

  2. WHO progression scale

    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

    Measured: at 4, 7 and 14 days after randomization

  3. Overall survival

    Measured: at 14 and 28 days after randomization

  4. Time from randomization to discharge

    Measured: Time until discharge up to 28 days

  5. Time to oxygen supply independency

    Measured: Time until oxygen supply independency up to 28 days

  6. Survival without needs of ventilator utilization

    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.

    Measured: At day 14 after randomization

  7. Survival without use of immunomodulatory drugs

    Survival without use of immunomodulatory drugs at day 14 of randomization (WHO score < 6). Thus, events considered are use of immunomodulatory drugs, or death.

    Measured: At day 14 after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2020
  2. Study start15 Apr 2020
  3. Primary completion28 May 2021
  4. Study completion28 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04345991
Sponsor's protocol ID
APHP200375-10
Other IDs
2020-001246-18
Acronym
CORIPLASM
Status last verified
Jun 2024
First submitted
10 Apr 2020
Last updated
7 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37920150

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Transfusion of COVID-19 convalescent plasma in people with Covid19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival without needs of ventilator utilization or use of immunomodulatory drugs (other than steroids) (time frame: At day 14 after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04345991, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.

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