An Observational Cohort Trial of Outcomes and Antibody Responses Following Treatment With COVID19 Convalescent Plasma in Hospitalized COVID-19 Patients
1 other identifier
observational
255
1 country
6
Brief Summary
This is an observational study designed to learn more about how COVID19 convalescent plasma works in patients with COVID19 compared to those patients who did not receive convalescent plasma treatment. Information about patient recovery will be collected from participants' electronic medical records to evaluate safety, clinical outcomes, and SARS-CoV2 antibody responses in patients who were treated with convalescent plasma under a separate expanded access protocol, NCT04372368.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 30, 2020
CompletedFirst Submitted
Initial submission to the registry
July 13, 2020
CompletedFirst Posted
Study publicly available on registry
July 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2020
CompletedJune 9, 2021
June 1, 2021
4 months
July 13, 2020
June 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Inpatient Mortality
Overall Inpatient Mortality
Hospital admission up to Day 28 or discharge
Requirement for mechanical ventilation
Number of patients requiring mechanical ventilation
Hospital admission up to Day 28 or discharge
Transfer to ICU
Number of patients transferred to an Intensive Care Unit (ICU)
Hospital admission up to Day 28 or discharge
ICU Mortality
Hospital admission up to Day 28 or discharge
ICU Length of Stay (LOS)
LOS, measured in days
Hospital admission up to Day 28 or discharge
Hospital Mortality
Hospital admission up to Day 28 or discharge
Hospital Length of Stay (LOS)
LOS, measured in days
Hospital admission up to Day 28 or discharge
Study Arms (1)
COVID19 Convalescent Plasma Treatment
Hospitalized COVID19 patients who receive COVID19 Convalescent Plasma under Expanded Access protocol NCT04372368.
Eligibility Criteria
Hospitalized patients treated with anti-SARS-CoV-2 convalescent plasma under the Expanded Access protocol NCT04372368. Patients with acute respiratory symptoms with or without confirmed interstitial COVID-19 pneumonia will be enrolled. This observational protocol will co-enroll patients in parallel with the expanded access protocol and expects to enroll approximately the same number of patients but no treatment will be provided as part of this protocol.
You may qualify if:
- Age 18 years or older
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing.
- Patient treated with COVID19 convalescent plasma.
- Patient or surrogate designated decision maker is willing and able to provide written informed consent.
You may not qualify if:
- Receipt of pooled immunoglobulin in past 30 days
- Contraindication to transfusion or history of prior reactions to transfusion blood products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
UCHealth Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
UCHealth Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John D Beckham, MD
University of Colorado, Denver
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2020
First Posted
July 14, 2020
Study Start
April 30, 2020
Primary Completion
August 20, 2020
Study Completion
August 20, 2020
Last Updated
June 9, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share