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Convalescent Plasma for Treatment of COVID-19: An Open Randomised Controlled Trial
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in which patients only received one dose of CP and a phase II study in which CP was given until viremia disappeared (unpublished data).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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Department of Infectious Disease, Falu Hospital
Falun, Dalarn, Sweden
Department of Geriatrics, Karolinska University Hospital
Stockholm, Sweden
Danderyd Hospital
Stockholm, Sweden
Start Date
December 3, 2020
Primary Completion Date
January 26, 2022
Completion Date
January 26, 2022
Last Updated
February 9, 2022
59
ACTUAL participants
SARS-CoV-2 convalescent plasma
BIOLOGICAL
Standard of care
OTHER
Lead Sponsor
Joakim Dillner
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06355232