NCT04333251

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2020

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

April 17, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2021

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

March 27, 2020

Last Update Submit

January 22, 2026

Conditions

Pneumonia, Interstitial

Outcome Measures

Primary Outcomes (1)

  • reduction in oxygen and ventilation support

    reduction in oxygen and ventilation support

    through study completion, an average of 4 weeks

Study Arms (2)

convalescent plasma

EXPERIMENTAL

This arm will receive convalescent plasma

Biological: high-titer anti-Sars-CoV-2 plasma

best supportive care

PLACEBO COMPARATOR

Oxygen therapy

Other: oxygen therapy

Interventions

high-titer anti-Sars-CoV-2 plasmaBIOLOGICAL

Recipients will receive 1-2 units of ABO matched donor plasma at neutralization antibody titer \>1:64 vs best supportive care

convalescent plasma
oxygen therapyOTHER

oxygen therapy

best supportive care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • must have been hospitalized w/COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing but are now PCR negative by 2 nasopharyngeal testing
  • females of child-bearing potential must have a negative serum pregnancy test
  • subject and/or LAR willing to provide informed consent
  • patient agrees to storage of specimens for future testing
  • years or older
  • must have been hospitalized w/COVID-19 respiratory symptoms within 3 to 7 days from the beginning of illness
  • subject and/or LAR willing to provide informed consent
  • patient agrees to storage of specimens for future testing

You may not qualify if:

  • years or older
  • receipt of pooled immunoglobulin in past 30 days
  • contraindication to transfusion or history of prior reactions to transfusion blood products
  • females who are identified as donors must not be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2020

First Posted

April 3, 2020

Study Start

April 17, 2020

Primary Completion

September 7, 2021

Study Completion

September 7, 2021

Last Updated

January 26, 2026

Record last verified: 2026-01