Convalescent Plasma in COVID-19 Elderly Patients (RESCUE)

Azienda Socio Sanitaria Territoriale di Mantova

Status and phase

Completed

Phase 2

Conditions

COVID-19

Treatments

Biological: Convalescent plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT04569188

Asstmantova

Details and patient eligibility

About

The trend of the spread of the COVID-19 pandemic demonstrates in Lombardy, starting from 28.03.2020, a slowdown in the exponential phase of infections and the probable reaching of a plateau phase.

However, a marked increase in infections was observed in the so-called "protected structures" such as nursing homes (RSA), both in health staff and in the residents of such facilities. The observed percentage of lethality, according to the more recent data provided by the National Institute of Health, is very high especially among residents.

For these reasons, the city Hospital (ASST) of Mantua , already involved in the use of hyperimmune plasma as a therapy for COVID-19, designed this study in order to evaluate RSA patients and to identify the cases eligible for this treatment.

Full description

For a detailed description of the study, see the attached protocol

Enrollment

21 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Elderly patients (> 65 years old) with SARS-CoV-2 RT-PCR positivity on nasal swab or score higher than 5 with the following characteristics:
- New onset or worsening of recently onset respiratory symptoms (<10 days);
- Radiological imaging (CT, X-ray, Ultrasound) of bilateral pulmonary opacities not fully explained by pleural effusion, pulmonary or lobar atelectasis, pulmonary nodules;
- Respiratory failure (SpO2 <95%) not fully explained by heart failure or water overload (after excluding hydrostatic causes of edema in the absence of risk factors by objective assessment, for example ultrasound);
Patients who have signed informed consent.

Exclusion criteria

New onset or worsening of respiratory symptoms that began more than 10 days ago;
Patients with proven hypersensitivity or allergic reaction to plasma, blood products or immunoglobulins;
Manifest desire not to be included in the research protocol.