Convalescent Plasma for Treatment of COVID-19: An Open Randomised Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Joakim Dillner
- Enrollment
- 59
- Locations
- 3
- Primary Endpoint
- COVID-19 related mortality within 28 days
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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in which patients only received one dose of CP and a phase II study in which CP was given until viremia disappeared (unpublished data).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.
Investigators
Joakim Dillner
Professor of Infectious Disease Epidemiology; Director of R&D
Karolinska University Hospital
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
Outcomes
Primary Outcomes
COVID-19 related mortality within 28 days
Time Frame: Measured 28 days after inclusion into the study.
Death of a study participant within 28 days.
Secondary Outcomes
- Requirement of invasive ventilation or Pao2/FiO2 ≤ 70 for ≥ 12 hours in the case of patients not eligible for intensive care(Until discharged from the hospital, up to 2 months)
- Time to clearance of viremia(Until discharged from the hospital, up to 2 months)
- Adverse events(The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.)
- COVID-19 related mortality within 60 days(Measured 60 days after inclusion into the study.)
- Dose of plasma needed to clear viremia(28 days)