Early transfusIon of Convalescent Plasma in Elderly COVID-19 Patients. to Prevent Disease Progression. (LIFESAVER)

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Coronavirus Disease 2019 )COVID-19)

Treatments

Biological: COVID-19 Convalescent Plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT04374526

3205

Details and patient eligibility

About

Older age is an independent poor outcome predictor among COVID-19 hospitalized patients . Among 72,314 COVID-19 cases, case fatality rate (CFR) was 2.3% in total population, 8% in people aged 70 to 79, and 14.8% in those aged 80 and older. In the whole population, CFR was higher in people with comorbidities, ranging from 5-6% in persons with hypertension, chronic respiratory disease, diabetes or cancer, up to 10% in those with cardiovascular diseases. Sars-CoV-2 seems to be able to induce a functional exhaustion of specified T and NK lymphocyte subpopulations, breaking down antiviral immunity. One possible explanation is that the immune system of elderly people, might be exhausted by chronic stimulation associated with comorbidities and more susceptible to this Sars-CoV-2 effect. As a result, in these patients, the activation of the innate immune system might fail to produce an adequate adaptive response (i.e., virus-specific CD8+ T-cells). This results in persistent self-induced inflammation that eventually causes mortality.

The investigators hypothesize that transfusing convalescent plasma (containing neutralizing antibodies) at an early phase of COVID-19 infection could prevent or switch off the persistent inflammatory response elicited by the virus.

The objective of this study are:

To demonstrate the superiority of COVID-19 convalescent plasma (CCP) plus standard therapy (ST) over ST alone
To prevent progression of pneumonia in COVID-19 patients aged ≥65 with chronic comorbidities
To decrease viral load
To raise anti-SARS-CoV-2 antibody titer in recipients

Enrollment

29 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 65
pneumonia at CT scan
PaO2/FiO2 ≥300 mmHg
Presence of one or more comorbidities (consider the list provided in Appendix A)
Signed informed consent

Exclusion criteria

Age < 65
PaO2/FiO2 < 300 mmHg
pending cardiopulmonary arrest
refusal to blood product transfusions
Severe IgA deficiency
any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion