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Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program

Primary Purpose

COVID-19

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Convalescent Plasma
Sponsored by
University of Arkansas
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Male or Female
  • 18 years of age or older
  • Laboratory confirmed COVID-19 via SARS-CoV-2 RT-PCR testing

  • Patients currently hospitalized with severe or life-threatening COVID-19 or patients the treating physician deems to be at high-risk for progressing to severe or life-threatening COVID-19.

    • Severe disease, defined as one or more of the following:

      • 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 disease, defined as one or more of the following:

      • respiratory failure,
      • septic shock, and/or
      • multiple organ dysfunction or failure
  • Patients or their legally authorized representative must provide informed consent.

Exclusion Criteria:

  • Female patients with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
  • Patients who have received pooled immunoglobulin in past 30 days
  • Contraindication to transfusions or history of prior reactions to transfusion blood products

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 23, 2020
    Last Updated
    March 1, 2023
    Sponsor
    University of Arkansas
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04363034
    Brief Title
    Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program
    Official Title
    Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Arkansas

    4. Oversight

    5. Study Description

    Brief Summary
    This is an expanded access treatment protocol to treat up to 100 patients with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma.
    Detailed Description
    This is an expanded access treatment protocol to treat up to 100 subjects with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma. Subjects will receive 1-2 units (200-400 mL per unit, not to exceed 550 mL total) of ABO compatible, low isohemagglutinin titer, COVID-19 convalescent plasma. Plasma will be administered one unit per day for up to two days. The duration of infusion will usually take 1 to 2 hours (rate of 100 to 250 mL/hr). The infusion should not exceed 4 hours. Plasma infusions will be administered following standard institutional procedures, including the use of premedications (e.g. acetaminophen, diphenhydramine, etc.) as necessary.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    Convalescent Plasma
    Intervention Description
    1-2 units (200-400 mL per unit, not to exceed 550 mL total) of ABO compatible, low isohemagglutinin titer, COVID-19 convalescent plasma

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Male or Female 18 years of age or older Laboratory confirmed COVID-19 via SARS-CoV-2 RT-PCR testing Patients currently hospitalized with severe or life-threatening COVID-19 or patients the treating physician deems to be at high-risk for progressing to severe or life-threatening COVID-19. Severe disease, defined as one or more of the following: 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 disease, defined as one or more of the following: respiratory failure, septic shock, and/or multiple organ dysfunction or failure Patients or their legally authorized representative must provide informed consent. Exclusion Criteria: Female patients with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period. Patients who have received pooled immunoglobulin in past 30 days Contraindication to transfusions or history of prior reactions to transfusion blood products

    12. IPD Sharing Statement

    Learn more about this trial

    Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program

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