CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasmadrug
Likely dose
High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma 2 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04374565
NCT04374565Phase 2Completed
CompareCT.gov

Efficacy and Safety of High-Titer Anti-SARS-CoV-2 (COVID19) Convalescent Plasma for Hospitalized Patients With Infection Due to COVID-19 to Decrease Complications: A Phase II Trial

University of Virginia·interventional·Posted May 5, 2020·Updated Apr 1, 2022

In Brief

A Phase 2 clinical trial evaluating High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma for Corona Virus Infection and 3 related conditions. Completed, enrolled 29 participants across 2 sites.

Detailed Summary

This is a single arm phase II trial to assess efficacy and confirm safety of infusions of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms,with or without confirmed interstitial COVID-19 pneumonia by chest Xray or CT. A total of 29 eligible subjects will be enrolled to receive anti-SARS-CoV-2 plasma.Outcomes will be compared to hospitalized controls with confirmed COVID-19 disease through retrospective chart review.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCorona Virus Infection, SARS-CoV 2, SARS Pneumonia, Pneumonia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 5, 2020
Enrollment StartMay 5, 2020
Primary CompletionMar 5, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.2 years ago

Interventions

High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasmadrug

Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; \~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.