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Convalescent Plasma in COVID-19 Elderly Patients (RESCUE)

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Convalescent plasma
Sponsored by
Azienda Socio Sanitaria Territoriale di Mantova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Transfusion Service

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

convalescent plasma

Arm Description

Cohort of elderly patients treated with convalescent plasma

Outcomes

Primary Outcome Measures

Death
Death from any cause

Secondary Outcome Measures

Viral load
Naso-pharyngeal swab

Full Information

First Posted
September 4, 2020
Last Updated
September 30, 2020
Sponsor
Azienda Socio Sanitaria Territoriale di Mantova
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1. Study Identification

Unique Protocol Identification Number
NCT04569188
Brief Title
Convalescent Plasma in COVID-19 Elderly Patients
Acronym
RESCUE
Official Title
Real-time Evaluation of Safety and Efficacy of Convalescent Plasma Units Transfused to Elderly Patients With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
August 15, 2020 (Actual)
Study Completion Date
September 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale di Mantova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
convalescent plasma
Arm Type
Experimental
Arm Description
Cohort of elderly patients treated with convalescent plasma
Intervention Type
Biological
Intervention Name(s)
Convalescent plasma
Intervention Description
COVID-19 elderly patients treated with convalescent plasma
Primary Outcome Measure Information:
Title
Death
Description
Death from any cause
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Viral load
Description
Naso-pharyngeal swab
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Franchini
Organizational Affiliation
ASST Mantova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Transfusion Service
City
Mantova
ZIP/Postal Code
46100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
33585799
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.
Results Reference
derived

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Convalescent Plasma in COVID-19 Elderly Patients

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