Convalescent Plasma in Hospitalized COVID-19 Patients

Azienda Socio Sanitaria Territoriale di Mantova

Status

Conditions: COVID-19

Treatments: Biological: Convalescent plasma

Study type: Expanded Access

Funder types: Other

Identifiers

NCT05157165

00001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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