Study Testing Convalescent Plasma vs Best Supportive Care | NCT04333251

Studies
Study Testing Convalescent Plasma vs Best Supportive Care

NCT04333251

Sponsor

Baylor Research Institute

Status

Withdrawn

Last Update Posted

Jan 26, 2026Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Pneumonia, Interstitial

Interventions

high-titer anti-Sars-CoV-2 plasma
oxygen therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding was not obtained and study was not activated

Expanded Access Info

Start Date

Apr 17, 2020Actual

Primary Completion Date

Sep 7, 2021Actual

Completion Date

Sep 7, 2021Actual

First Submitted Date

Mar 27, 2020

First Submission Date that Met QC Criteria

Apr 2, 2020

First Posted Date

Apr 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2026

Last Update Posted Date

Jan 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
high-titer anti-Sars-CoV-2 plasma	Biological	Recipients will receive 1-2 units of ABO matched donor plasma at neutralization antibody titer >1:64 vs best supportive care	convalescent plasma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduction in oxygen and ventilation support	reduction in oxygen and ventilation support	through study completion, an average of 4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria Donor:

18 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

Inclusion Criteria Recipient:

18 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

Exclusion Criteria:

18 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D018011	Chalcogens
D004602	Elements
D007287	Inorganic Chemicals
D005740	Gases