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An Observational Cohort Trial of Outcomes and Antibody Responses Following Treatment With COVID19 Convalescent Plasma in Hospitalized COVID-19 Patients

Covid19 Clinical Trial

Official title:
An Observational Cohort Trial of Outcomes and Antibody Responses Following Treatment With COVID19 Convalescent Plasma in Hospitalized COVID-19 Patients

Clinical Trial 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.

Clinical Trial Description

This a prospective, observational cohort trial to evaluate safety, clinical outcomes, and SARS-CoV2 antibody responses in patients who were treated with anti-SARS-CoV-2 convalescent plasma under Expanded Access protocol, NCT04372368. Hospitalized patients with acute respiratory symptoms with or without confirmed interstitial COVID-19 pneumonia will be enrolled. The investigators anticipate that a minimum of 150 eligible subjects will be enrolled to receive COVID19 convalescent plasma over the 12 month period for the FDA IND expanded access protocol, NCT04372368, to provide COVID19 convalescent serum, which is a separate treatment trial. 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. Additionally, the investigators will use Compass data with identifiers to pull information on hospitalized control COVID19+ patients from hospital admission date 4/20 to current for comparison. This protocol is limited to data collection using the EMR to evaluate outcomes following COVID19 convalescent plasma treatment. Patient-linked specimens will not be obtained and analyzed outside of the expanded access protocol for distribution of COVID19 convalescent plasma. For this protocol, only de-identified, discarded samples may be obtained during routine patient care. Thus, consent will only be obtained from patients/subjects for participation in data abstraction/analysis from the electronic medical record. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04471051
Study type Observational
Source University of Colorado, Denver
Contact
Status Completed
Phase
Start date April 30, 2020
Completion date August 20, 2020
View Details
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