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Convalescent Plasma in Hospitalized COVID-19 Patients

Sponsor
Azienda Socio Sanitaria Territoriale di Mantova (Other)
Overall Status
Available
CT.gov ID
NCT05157165
Collaborator
(none)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Convalescent plasma

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.

Study Design

Study Type:
Expanded Access
Official Title:
Convalescent Plasma in Hospitalized COVID-19 Patients: a Single Center Experience

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Azienda Socio Sanitaria Territoriale di Mantova

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Massimo Franchini, Director Immunohematology and Transfusion Center, Azienda Socio Sanitaria Territoriale di Mantova
    ClinicalTrials.gov Identifier:
    NCT05157165
    Other Study ID Numbers:
    • 00001
    First Posted:
    Dec 14, 2021
    Last Update Posted:
    Dec 14, 2021
    Last Verified:
    Dec 1, 2021
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Dec 14, 2021