No specific therapeutic agents or vaccines for COVID-19 are available. Several therapies, are under investigation, but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma was recommended as an empirical treatment during outbreaks of Ebola virus in 2014, and a protocol for treatment of Middle East respiratory syndrome coronavirus with convalescent plasma was established in 2015. Accordingly, we hypothesized that use of convalescent plasma transfusion could be beneficial in patients infected with SARS-CoV-2. This is a multicenter prospective randomized clinical trial to evaluate safety and efficacy of early use of convalescent plasma in patients with SARS-CoV2 pneumonia. Primary endpoint will be the efficacy, evaluated as the need of invasive mechanical ventilation defined by PaO2/FiO2 ratio
This is a multicenter prospective randomized open-label clinical trials. Patients with
pneumonia due to SARS-CoV-2 will be included and randomized to receive or not convalescent
plasma.
Convalescent plasma will be collected by cured patients with previous diagnosis of COVID-19.
More specifically, inclusion and exclusion criteria for donors will be the following.
Inclusion criteria for donors:
- age > 18 and <60 years
- confirmed diagnosis of COVID-19: PCR on nasopharynx swab or positive IgG
- presence of 2 negative nasopharynx swabs for patients with previous positive swab and
presence of 1 negative nasopharynx swab for patients with positive IgG
Exclusion criteria for donors:
- age < 18 ys or >60 ys
- other conditions that controindicate blood donation
Collected plasma will undergo all procedures for blood preparation. Plasma will be tested
with enzyme-linked immunosorbent assay (ELISA) and neutralizing antibody titers.
Patients eligible for the study will be selected among hospitalized patients with SARS-CoV2
pneumonia. More specifically, the following criteria will used for inclusion in the study.
Inclusion criteria for recipients:
- age >18 ys
- confirmed diagnosis of SARS-CoV2 pneumonia
- PaO2/FiO2 200-350
Exclusion criteria for recipients:
- PaO2/FiO2 <200
- need of non invasive or invasive mechanical ventilation
Patients will be randomized 1:1 to receive or not convalescent plasma. All patients will be
followed-up for 30 days after randomization.
Primary endpoint will be the need of mechanical ventilation, defined as PaO2/FiO2 <150.
Biological: CONVALESCENT PLASMA
Convalescent plasma will be collected by healthy donors, cured by COVID-19 and, after standard preparation and dosage of neutralizing antibodies, will be administered to patients with SARS-CoV2 pneumonia
Inclusion Criteria:
- Any gender
- Age > 18 years on day of signing informed consent
- Informed written consent for participation in the study
- Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
- Hospitalized due to clinical instrumental diagnosis of pneumonia
- PaO2/FiO2 ratio 200-350
Exclusion Criteria:
- mechanical ventilation (both invasive and non-invasive)
- PaO2/FiO2<200
- known hypersensitivity to immunoglobulin or blood components
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Francesco Menichetti, Principal Investigator
Azienda Ospedaliero, Universitaria Pisana