Clinical trial NCT04569188: Convalescent Plasma in COVID-19 Elderly Patients
Official title: Real-time Evaluation of Safety and Efficacy of Convalescent Plasma Units Transfused to Elderly Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Azienda Socio Sanitaria Territoriale di Mantova
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Death
timeFrame: 15 days
Secondary outcomes:
measure: Viral load
timeFrame: 7 days
Other outcomes:
Locations:
city: Mantova
country: Italy
facility: Transfusion Service
Study officials:
affiliation: ASST Mantova
name: Massimo Franchini
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franchini M, Glingani C, Morandi M, Corghi G, Cerzosimo S, Beduzzi G, Storti A, Di Stasi V, Rastrelli G, Vignozzi L, Mengoli C, Garuti M, Beccaria M, Inglese F, Caruso B, Petilino RA, Amato M, Nicchio M, Pagani M, Bellani A, Castelli G, Casari S, De Donno G. Safety and Efficacy of Convalescent Plasma in Elderly COVID-19 Patients: The RESCUE Trial. Mayo Clin Proc Innov Qual Outcomes. 2021 Apr;5(2):403-412. doi: 10.1016/j.mayocpiqo.2021.01.010. Epub 2021 Feb 8.