Convalescent Plasma in Hospitalized COVID-19 Patients

NCT ID: NCT05157165

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

COVID-19

Interventions

Convalescent plasma

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Socio Sanitaria Territoriale di Mantova

OTHER

Sponsor Role: lead

Responsible Party

Massimo Franchini

Director Immunohematology and Transfusion Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

00001

Identifier Type: -

Identifier Source: org_study_id