Status:
COMPLETED
TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa in COVID-19 Patients
Lead Sponsor:
Istituto Superiore di Sanità
Collaborating Sponsors:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Agenzia Italiana del Farmaco
Conditions:
Covid19
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a multicenter open-label randomized study for the early treatment of pneumonia due to SARS-COV2 with transfusion of convalescent plasma. Patients with pneumonia due to SARS-CoV-2 will be rand...
Detailed Description
This is a multicenter open-label randomized study for the early treatment of pneumonia due to SARS-COV2 with transfusion of convalescent plasma. Patients with SARS-CoV2 pneumonia not requiring mechan...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- adult patients with positive RT-PCR test for SARS-CoV2 (nasal swabs or lower respiratory tract sample), diagnosed with pneumonia (\<= 10 days) according to the following definitions:
- Suggestive radiological imaging (CT, RX, ultrasound);
- Respiratory failure not fully explained by heart failure or fluid overload;
- PaO2/FiO2 200-350 mmHg;
- Signed informed consent
Exclusion
- need of non invasive or invasive mechanical ventilation at the time of randomization;
- PaO2/FiO2 \<200;
- patients with hypersensitivity or allergic reaction to blood products or immunoglobulins;
- patients who expressly refuse to adhere the clinical study;
- use of IL-6 Receptor inhibitors, IL-1 inhibitors, JAK inhibitors, TNF inhibitors;
- patients participating to other clinical trial.
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
474 Patients enrolled
Trial Details
Trial ID
NCT04716556
Start Date
July 16 2020
End Date
May 31 2021
Last Update
August 26 2021
Active Locations (48)
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1
SOD Clinica Malattie Infettive Tropicali, Parassitologia, Epatiti Croniche - AOU Ospedali Riuniti di Ancona
Ancona, Italy
2
Ospedale di Arezzo
Arezzo, Italy
3
Clinica Malattie Infettive, Università degli Studi di Bari
Bari, Italy
4
Ospedale Papa Giovanni XXIII-Dip. emergenza, Urgenza e area critica
Bergamo, Italy