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Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program

Sponsor
University of Arkansas (Other)
Overall Status
No longer available
CT.gov ID
NCT04363034
Collaborator
(none)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: 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.

Study Design

Study Type:
Expanded Access
Official Title:
Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Arkansas

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Arkansas
    ClinicalTrials.gov Identifier:
    NCT04363034
    Other Study ID Numbers:
    • 260944
    First Posted:
    Apr 27, 2020
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Mar 29, 2022