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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT04471051
Collaborator
(none)
255
6
3.7
42.5
11.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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

    Study Type:
    Observational
    Actual Enrollment :
    255 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Observational Cohort Trial of Outcomes and Antibody Responses Following Treatment With COVID19 Convalescent Plasma in Hospitalized COVID-19 Patients
    Actual Study Start Date :
    Apr 30, 2020
    Actual Primary Completion Date :
    Aug 20, 2020
    Actual Study Completion Date :
    Aug 20, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    COVID19 Convalescent Plasma Treatment

    Hospitalized COVID19 patients who receive COVID19 Convalescent Plasma under Expanded Access protocol NCT04372368.

    Outcome Measures

    Primary Outcome Measures

    1. Inpatient Mortality [Hospital admission up to Day 28 or discharge]

      Overall Inpatient Mortality

    2. Requirement for mechanical ventilation [Hospital admission up to Day 28 or discharge]

      Number of patients requiring mechanical ventilation

    3. Transfer to ICU [Hospital admission up to Day 28 or discharge]

      Number of patients transferred to an Intensive Care Unit (ICU)

    4. ICU Mortality [Hospital admission up to Day 28 or discharge]

    5. ICU Length of Stay (LOS) [Hospital admission up to Day 28 or discharge]

      LOS, measured in days

    6. Hospital Mortality [Hospital admission up to Day 28 or discharge]

    7. Hospital Length of Stay (LOS) [Hospital admission up to Day 28 or discharge]

      LOS, measured in days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital Colorado Aurora Colorado United States 80045
    2 University of Colorado Hospital Aurora Colorado United States 80045
    3 UCHealth Memorial Hospital North Colorado Springs Colorado United States 80920
    4 Denver Health Medical Center Denver Colorado United States 80204
    5 UCHealth Poudre Valley Hospital Fort Collins Colorado United States 80524
    6 UCHealth Highlands Ranch Hospital Highlands Ranch Colorado United States 80129

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

    • Principal Investigator: John D Beckham, MD, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT04471051
    Other Study ID Numbers:
    • 20-0986
    First Posted:
    Jul 14, 2020
    Last Update Posted:
    Jun 9, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University of Colorado, Denver
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 9, 2021