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Completed

NCT Number: NCT04471051

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Inpatient Mortality

    Time frame: Hospital admission up to Day 28 or discharge

    Overall Inpatient Mortality

  2. Requirement for mechanical ventilation

    Time frame: Hospital admission up to Day 28 or discharge

    Number of patients requiring mechanical ventilation

  3. Transfer to ICU

    Time frame: Hospital admission up to Day 28 or discharge

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

  4. ICU Mortality

    Time frame: Hospital admission up to Day 28 or discharge

  5. ICU Length of Stay (LOS)

    Time frame: Hospital admission up to Day 28 or discharge

    LOS, measured in days

  6. Hospital Mortality

    Time frame: Hospital admission up to Day 28 or discharge

  7. Hospital Length of Stay (LOS)

    Time frame: Hospital admission up to Day 28 or discharge

    LOS, measured in days

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 14, 2020
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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