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Convalescent Plasma in Hospitalized COVID-19 Patients

Primary Purpose

COVID-19

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Convalescent plasma
Sponsored by
Azienda Socio Sanitaria Territoriale di Mantova
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:

  • Adult patients admitted for severe COVID-19

Exclusion Criteria:

  • < 18 years
  • participation in any other clinical trial of an experimental treatment for COVID-19

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 10, 2021
    Last Updated
    July 19, 2023
    Sponsor
    Azienda Socio Sanitaria Territoriale di Mantova
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05157165
    Brief Title
    Convalescent Plasma in Hospitalized COVID-19 Patients
    Official Title
    Convalescent Plasma in Hospitalized COVID-19 Patients: a Single Center Experience
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    July 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
    Principal Investigator
    Name of the Sponsor
    Azienda Socio Sanitaria Territoriale di Mantova

    4. Oversight

    5. Study Description

    Brief Summary
    The study assesses the efficacy and safety of administration of hyperimmune plasma in hospitalized COVID-19 patients. Efficacy was measured as 28-day mortality following convalescent plasma transfusion. Safety was measured as the rate of adverse reactions. to plasma infusion.
    Detailed Description
    Inclusion criteria: Adult inpatients with a severe form of COVID-19 have been enrolled, with at least one of the following inclusion criteria: 1) tachypnea with respiratory rate (RR) > 30 breaths/min; 2) oxygen saturation (SpO2) ≤ 93% at rest and in room air; 3) partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤ 200 mmHg, 4) radiological picture and/or chest CT scan showing signs of interstitial disease and/or rapid progression of lung involvement. Primary outcome: Overall mortality at 28 days after hospitalization Secondary outcome: Adverse reaction to plasma transfusion.

    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
    Hyperimmune plasma from convalescent COVID-19 donors with titre 1:80 or more

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Adult patients admitted for severe COVID-19 Exclusion Criteria: < 18 years participation in any other clinical trial of an experimental treatment for COVID-19

    12. IPD Sharing Statement

    Learn more about this trial

    Convalescent Plasma in Hospitalized COVID-19 Patients

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