Convalescent Plasma for Treatment of COVID-19

NCT ID: NCT04649879

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-03
• Study Completion Date: 2022-01-26

Brief Summary

Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicate that it is safe for treatment of COVID-19. We found that viremia upon admission identifies patients at 7 fold increased risk of admission to intensive care and 8 fold increased risk of death. CP treatment appeared to result in rapid viral clearance in a small case series. CP appeared to be well tolerated in a phase I study in which patients only received one dose of CP and a phase II study in which CP was given until viremia disappeared (unpublished data).

Randomised controlled studies assessing the efficacy of CP are lacking and thus the efficacy of CP is unknown. Preliminary data indicate that treatment should be given early, prior to development of severe illness. Detection of viremia upon admission identifies a group at high risk of severe disease and death that has the most to benefit from CP. Phase II study data indicates that treatment should be given until SARS-CoV-2 is no longer detected in serum and the donor antibody neutralization titres should be ≥1/640. A randomised controlled trial in which viremic patients are treated with CP with the equivalent of an antibody titre ≥1/640 is thus required to determine if CP can be an effective COVID-19 treatment.

Conditions

Covid19

Study Design

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

Study Groups

Convalescent plasma treatment

• Participants will receive 200 ml convalescent plasma daily until SARS-CoV-2 is no longer detectable in the blood up to a maximum of 10 CP infusions.
• If steroid therapy has not already been initiated, betamethasone 3 mg daily will be given concomitantly with steroid therapy or longer if clinically indicated but for a maximum of 10 days.

Group Type: EXPERIMENTAL

SARS-CoV-2 convalescent plasma

Intervention Type: BIOLOGICAL

Participants will receive 200 ml convalescent plasma daily until SARS-CoV-2 is no longer detectable in the blood up to a maximum of 10 CP infusions. CP will be given as a slow infusion over 2 hours. CP neutralization titre of ≥ 1/640 or an ELISA reactivity against the Spike protein of SARS-CoV-2 by the Euroimmun commercial assay \>9 is desired. New antibody tests are under development and can be used instead if equivalence to neutralization or Euroimmun ELISA is demonstrated.

Control

Standard of care for COVID-19 patients.

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: OTHER

Standard of care as determined by hospital practices for COVID-19 patients.

Interventions

SARS-CoV-2 convalescent plasma

Participants will receive 200 ml convalescent plasma daily until SARS-CoV-2 is no longer detectable in the blood up to a maximum of 10 CP infusions. CP will be given as a slow infusion over 2 hours. CP neutralization titre of ≥ 1/640 or an ELISA reactivity against the Spike protein of SARS-CoV-2 by the Euroimmun commercial assay \>9 is desired. New antibody tests are under development and can be used instead if equivalence to neutralization or Euroimmun ELISA is demonstrated.

Intervention Type: BIOLOGICAL

Standard of care

Standard of care as determined by hospital practices for COVID-19 patients.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age greater than or equal to 18
• Admitted to a study hospital
• Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples and blood
• Negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential
• Written informed consent after meeting with a study physician and ability and willingness to complete follow up

Exclusion Criteria

• No matching plasma donor (Exact matching in the ABO system is required)
• Unavailability of plasma
• Estimated glomerular filtration rate <30 (kidney failure stage III or more)
• Pregnancy (urinary-hcg)
• Breast feeding
• Inability to give informed consent

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

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Danderyd Hospital

OTHER

Sponsor Role: collaborator

Falu Hospital

OTHER

Sponsor Role: collaborator

Joakim Dillner

OTHER

Sponsor Role: lead

Responsible Party

Joakim Dillner

Professor of Infectious Disease Epidemiology; Director of R&D

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Infectious Disease, Falu Hospital

Falun, Dalarn, Sweden

Department of Geriatrics, Karolinska University Hospital

Stockholm, , Sweden

Danderyd Hospital

Stockholm, , Sweden

Countries

Sweden

References

Dillner J, Ursing J. Convalescent plasma for treatment of COVID-19: study protocol for an open randomised controlled trial in Sweden. BMJ Open. 2021 Dec 8;11(12):e048337. doi: 10.1136/bmjopen-2020-048337.

Reference Type: DERIVED

PMID: 34880010 (View on PubMed)

Other Identifiers

CP3

Identifier Type: -

Identifier Source: org_study_id