Convalescent Plasma for Treatment of COVID-19

NCT04649879 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2022-02-09

No results posted yet for this study

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in which patients only received one dose of CP and a phase II study in which CP was given until viremia disappeared (unpublished data).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

Interventions

BIOLOGICAL

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.

OTHER

Standard of care

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

Sponsors & Collaborators

Karolinska Institutet
collaborator OTHER
Danderyd Hospital
collaborator OTHER
Falu Hospital
collaborator OTHER
Joakim Dillner
lead OTHER

Study Design

Allocation: RANDOMIZED
Purpose: TREATMENT
Masking: NONE
Model: PARALLEL

Eligibility

Min Age: 18 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2020-12-03
Primary Completion: 2022-01-26
Completion: 2022-01-26

Countries

Sweden

Study Locations

More Related Trials

Entities

Companies

Karolinska Institutet