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 proposed clinical Phase II trial addresses the FY20 PRMRP Focus Area Respiratory Health and the interest area of pharmacological and biologic interventions for COVID-19-induced complications, including acute respiratory distress syndrome and related sequelae. The novel coronavirus SARS-CoV-2 is currently causing a worldwide pandemic with over 8,979,539 cases as of June 22, 2020. The virus also poses a significant threat to Service members, their families, Veterans and DoD contractors. As of June 22, 2020, there were 14,073 cumulative cases among the DoD population and 18,794 among our Veterans. There continues to be significant risk of infection into the foreseeable future for all populations with a high cost to individuals impacted and to the DoD, VA, and civilian health systems. There is currently no proven effective therapy for coronavirus disease (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The virus appears to cause multiorgan failure through several mechanisms, including a severe inflammatory response leading to acute respiratory distress syndrome. Convalescent plasma has been successfully used for treatment of other viral infections and is actively being evaluated for the treatment of COVID-19. Plasma can be frozen and rapidly available. It has also been shown to be safe with few adverse events. Plasma from selected donors with a high level of neutralizing COVID-19 antibodies (>1:1000) will be collected and infused into patients with COVID-19 infections. We will evaluate the efficacy of this approach in preventing the progression of the disease and the hospitalization, morbidity, and mortality of these patients. This Phase II randomized study of convalescent plasma from selected recovered COVID-19 donors collected by plasmapheresis as treatment for subjects with early COVID-19 infection (less than 96 hours from the onset of symptoms) is anticipated to provide early viral neutralization, thus preventing the tissue damage and severe sequelae from uncontrolled viral infection. Since plasma can be frozen, this therapy can be immediately available to the DoD population and Veterans, in many diverse settings. If successful, it would significantly reduce COVID-19-associated hospitalization and deaths for the DoD and Veterans communities as well as the general population. Due to the broad availability, ease of procurement and relatively low cost of convalescent plasma, this therapy could be adopted rapidly and broadly.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110064
Entities
People
- Michele Donato
Organizations
- Hackensack University Medical Center
- United States Army