NCT04392232

Brief Summary

Purpose of Study • The purpose of this study to evaluate, the effectiveness of convalescent plasma in combatting the symptoms and effects of the coronavirus disease, COVID-19. Beyond supportive care, there are no proven treatment options for COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

May 5, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2021

Completed
Last Updated

December 7, 2021

Status Verified

December 1, 2021

Enrollment Period

1.4 years

First QC Date

May 15, 2020

Last Update Submit

December 3, 2021

Conditions

CoronavirusCOVID-19Convalescent Plasma

Outcome Measures

Primary Outcomes (1)

  • Survival Rate

    % patients who survived

    At 28 Days

Study Arms (1)

Convalescent Plasma

EXPERIMENTAL
Drug: Convalescent Plasma

Interventions

Convalescent PlasmaDRUG

• Investigational Product o COVID-19 convalescent plasma will be obtained from an FDA-registered blood establishment (Hoxworth) that follows donor eligibility criteria and donor qualifications as outlined in section III.C.I of the Investigational COVID-19 Convalescent Plasma Guidance for Industry.

Convalescent Plasma

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Previous history of life threatening or severe adverse reactions to transfusion blood products..

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Thomas E. Coyle, MD

    TriHealth Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Non-Randomized, single arm study of convalescent plasma treatment of covid 19.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 18, 2020

Study Start

May 5, 2020

Primary Completion

September 21, 2021

Study Completion

September 21, 2021

Last Updated

December 7, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)