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Convalescent Plasma for Treatment of COVID-19 Patients With Pneumonia

NCT04374565 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2022-04-01

Study results available
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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.

Conditions

  • Corona Virus Infection
  • SARS-CoV 2
  • SARS Pneumonia
  • Pneumonia

Interventions

DRUG

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

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.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-05
Primary Completion
2021-03-05
Completion
2021-03-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04374565 on ClinicalTrials.gov