NCT04333251

Study Testing Convalescent Plasma vs Best Supportive Care

Evaluating Convalescent Plasma to Decrease Coronavirus Associated Complications. A Phase I Study Comparing the Efficacy and Safety of High-titer Anti-Sars-CoV-2 Plasma vs Best Supportive Care in Hospitalized Patients With Interstitial Pneumonia Due to COVID-19

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Currently there are no proven treatment option for COVID-19. Human convalescent plasma is an option for COVID-19 treatment and could be available from people who have recovered and can donate plasma.

Detailed description

Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1 shows that convalescent plasma contains neutralizing antibodies to the relevant virus. In the case of SARS-CoV-2, the anticipated mechanism of action by which passive antibody therapy would mediate protection is viral neutralization. The only antibody type that is currently available for immediate use is that found in human convalescent plasma. As more individuals contract COVID-19 and recover, the number of potential donors will continue to increase. The investigators seek to treat participants who are sick enough to warrant hospitalization prior to the onset of overwhelming disease.

Conditions

• Pneumonia, Interstitial

Interventions

Type	Name	Description
BIOLOGICAL	high-titer anti-Sars-CoV-2 plasma	Recipients will receive 1-2 units of ABO matched donor plasma at neutralization antibody titer \>1:64 vs best supportive care
OTHER	oxygen therapy	oxygen therapy

Timeline

• Start date: 2020-04-17
• Primary completion: 2021-09-07
• Completion: 2021-09-07
• First posted: 2020-04-03
• Last updated: 2026-01-26