Convalescent Plasma in COVID-19 Elderly Patients

Real-time Evaluation of Safety and Efficacy of Convalescent Plasma Units Transfused to Elderly Patients With COVID-19

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04569188

Acronym

RESCUE

Enrollment

Registered

2020-09-29

Start date

2020-05-15

Completion date

2020-09-03

Last updated

2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

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

Interventions

BIOLOGICALConvalescent plasma

COVID-19 elderly patients treated with convalescent plasma

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Death	15 days	Death from any cause

Secondary

Measure	Time frame	Description
Viral load	7 days	Naso-pharyngeal swab

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026