Phase 2 Randomized Study of Convalescent Plasma from Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Subjects with Early COVID-19 Infection
Abstract
The novel coronavirus, SARS-CoV-2, is currently causing a worldwide pandemic with over 8,979,539 cases as of June 22nd, 2020. There is currently no therapy for SARS-CoV-2, and the need for therapeutic options is urgent. The virus appears to cause multiorgan failure through several mechanisms, including a severe inflammatory response leading to acute respiratory distress syndrome. We are currently accruing patients on study under our IND 19824 of hospitalized patients with COVID-19 infections. With 47/55 patients accrued on this study, we have found that most patients (87%) are showing anti-SARS-CoV2 titer 1:100 by the time of plasma request as very few patients are hospitalized during their first week of symptoms. Conceptually, the use of convalescent plasma is to prevent further viral invasion pending adaptive immunity. Early viral neutralization may prevent the ensuing inflammatory and coagulation cascade. The purpose of this phase 2 one-year trial is to intervene in the early phase of viral infection (within 96 hours of first symptoms) to prevent hospitalization and mortality in the high-risk population.
Document Details
- Document Type
- Technical Report
- Publication Date
- Mar 01, 2022
- Accession Number
- AD1174949
Entities
People
- Michele Donato
Organizations
- Hackensack University Medical Center