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Completed

NCT Number: NCT04340050

COVID-19 Convalescent Plasma

The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19.

Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma.

Hypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers.

Objective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.

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Key information

Conditions

Coronavirus 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

Interventional

Phase

Early Phase 1

Primary location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

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

Donor Inclusion Criteria:

  • Age greater or equal to 18
  • Able to donate blood per blood bank standard guidelines
  • Prior diagnosis of COVID-19 documented by a laboratory test (confirmed)
  • Complete resolution of symptoms at least 28 days prior to donation
  • Female donors who have never been pregnant, previously pregnant female donors negative for HLA antibodies (HLA screening), or male donors

Donor Exclusion Criteria:

  • Does not provide consent
  • Does not meet standard blood bank donation guidelines
  • Unsuccessful blood donation

Recipient Inclusion Criteria:

  • Patients must be 18 years of age or older
  • Must have laboratory-confirmed COVID-19
  • Must have severe or immediately life-threatening COVID-19
  • Severe defined as dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours
  • Life-threatening defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Lower priority should be given to patients with septic shock or multiple organ dysfunction or failure since their disease may have progressed to a point where they are not able to benefit from convalescent plasma therapy.
  • Must be less than 21 days from the start of illness
  • Patient is willing and able to provide written informed consent and comply with all protocol requirements. If the patient is not able to consent, we will obtain consent from the power of attorney or a health care proxy for the patient as determined by the Illinois Healthcare Surrogate Act
  • Patient, power of attorney or health care proxy agrees to storage of specimens for future testing.
  • Of note, eIND application for each recipient subject will need to be approved before administration of convalescent plasma

Recipient Exclusion Criteria:

  • Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
  • Receipt of pooled immunoglobulin in past 30 days
  • Contraindication to transfusion or history of prior reactions to transfusion blood products
  • Patients currently enrolled in other drug trials that preclude investigational treatment with anti-SARS-CoV-2 convalescent plasma

Treatment and study plan

anti-SARS-CoV-2 convalescent plasma

Biological

Infusion of one unit of anti-SARS-CoV-2 convalescent plasma ~300 mL over 4 hours

Primary outcomes

  1. Success of Administering Plasma

    Time frame: At time of administration

    Number of patients who receive convalescent plasma

  2. Type of Respiratory Support

    Time frame: Until discharge from hospital

    Levels of respiratory support will be graded (e.g. room air, high flow oxygen, intubation) to determine the change in type of respiratory support at 28 days.

Secondary outcomes

  1. Cardiac Arrest

    Time frame: 28 days after plasma administration

    Number of patients experiencing cardiac arrest.

  2. Transfer to ICU

    Time frame: 28 days

    Number of patients transferred to ICU

  3. ICU Mortality

    Time frame: Until discharge

    Number of patients dying in the ICU

  4. ICU Length of Stay

    Time frame: Up to 50 days

    This will be a continuous outcome defined by the amount of time between plasma administration and discharge from ICU. This will be treated as a time-to-event.

  5. Hospital Mortality

    Time frame: Until discharge

    Mortality during course of illness

  6. Hospital Length of Stay

    Time frame: Until discharge

    This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.

  7. Ventilator-free Days

    Time frame: 28 days

    This will be a continuous outcome defined by the amount of time between plasma administration and the transition from mechanical ventilation to non-invasive respiratory support.

  8. Overall Survival (28-day Mortality)

    Time frame: 28 days

    28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of plasma administration.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Pilot Study for Use of Convalescent Plasma Collected From Patients Recovered From COVID-19 Disease for Transfusion as an Empiric Treatment During the 2020 Pandemic at the University of Chicago Medical Center

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2020
Registry last updated
Feb 28, 2024

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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