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 Details — Status: Completed

Administrative data

• NCT number: NCT04471051
• Other study ID #: 20-0986
• Status: Completed
• Start date: April 30, 2020
• Est. completion date: August 20, 2020

Study information

• Verified date: June 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: August 20, 2020
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Receipt of pooled immunoglobulin in past 30 days

• Contraindication to transfusion or history of prior reactions to transfusion blood products

Related Conditions & MeSH terms

• Covid19

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of Colorado Hospital	Aurora	Colorado
United States	UCHealth Memorial Hospital North	Colorado Springs	Colorado
United States	Denver Health Medical Center	Denver	Colorado
United States	UCHealth Poudre Valley Hospital	Fort Collins	Colorado
United States	UCHealth Highlands Ranch Hospital	Highlands Ranch	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inpatient Mortality	Overall Inpatient Mortality	Hospital admission up to Day 28 or discharge
Primary	Requirement for mechanical ventilation	Number of patients requiring mechanical ventilation	Hospital admission up to Day 28 or discharge
Primary	Transfer to ICU	Number of patients transferred to an Intensive Care Unit (ICU)	Hospital admission up to Day 28 or discharge
Primary	ICU Mortality		Hospital admission up to Day 28 or discharge
Primary	ICU Length of Stay (LOS)	LOS, measured in days	Hospital admission up to Day 28 or discharge
Primary	Hospital Mortality		Hospital admission up to Day 28 or discharge
Primary	Hospital Length of Stay (LOS)	LOS, measured in days	Hospital admission up to Day 28 or discharge