Status:
COMPLETED
A Study of COVID 19 Convalescent Plasma in High Risk Patients With COVID 19 Infection
Lead Sponsor:
TriHealth Inc.
Conditions:
Coronavirus
COVID-19
Eligibility:
All Genders
16+ years
Phase:
PHASE2
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,...
Detailed Description
Hypothesis or Research Question • Is convalescent plasma from patients previously infected with COVID-19 an effective treatment option for high risk patients through the utilization of passive immunit...
Eligibility Criteria
Inclusion
- • Eligibility Criteria
- Participants will be 16 years or older.
- COVID-19 infection demonstrated via SARS-CoV-2 PCR testing.
- Admitted to the hospital for treatment of Covid 19.
- Patients must have severe/high risk disease as defined by the presence of any one of the following:
- Respiratory frequency ≥ 25/minute Oxygen saturation ≤ 93% on room air Partial pressure of arterial oxygen to fraction of inspired oxygen ration \< 300, or pulse oximetric saturation to fraction of inspired oxygen ratio \< 315.
- Lung infiltrates \> 50% within 24-48 hours of admission on Chest X-Ray or, Ferritin \> 1000 or absolute lymphocyte count \< 600 or D-Dimer \> 1.00
- ABO Blood Type available.
- Pregnant women will be permitted to participate in this study.
- • Exclusion criteria
- Previous history of life threatening or severe adverse reactions to transfusion blood products..
Exclusion
Key Trial Info
Start Date :
May 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2021
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT04392232
Start Date
May 5 2020
End Date
September 21 2021
Last Update
December 7 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
2
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242