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CompletedNCT04569188RESCUEUpdated Oct 5, 2020

Convalescent Plasma in COVID-19 Elderly Patients

A Phase 2 interventional study of Convalescent plasma in COVID-19, sponsored by Azienda Socio Sanitaria Territoriale di Mantova. Completed at 1 site in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-10-05.

Sponsored by Azienda Socio Sanitaria Territoriale di Mantova · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2020, registered Sep 2020).
Phase
Phase 2
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • COVID-19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 21 is below the median of 100 across 4,098 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Azienda Socio Sanitaria Territoriale di Mantova is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    convalescent plasma

    Cohort of elderly patients treated with convalescent plasma

    Biological: Convalescent plasma

Interventions

  • BiologicalConvalescent plasma

    COVID-19 elderly patients treated with convalescent plasma

06

What researchers measure

Primary outcomes

  1. Death

    Death from any cause

    Time frame: 15 days

Secondary outcomes

  1. Viral load

    Naso-pharyngeal swab

    Time frame: 7 days

07

Study locations

1 site
  • Transfusion Service
    Mantova, 46100, Italy
08

References and documents

Publications

  • 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. PubMed 33585799 ↗

Study documents

  • Study protocol · May 15, 2020

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04569188
Lead sponsor
Azienda Socio Sanitaria Territoriale di Mantova
Responsible party
Massimo Franchini (Director Immunohematology and Transfusion Service, Azienda Socio Sanitaria Territoriale di Mantova) — Principal investigator
First posted
Sep 29, 2020
Start date
May 15, 2020
Primary completion
Aug 15, 2020
Completion
Sep 3, 2020
Last update
Oct 5, 2020

Study contacts

Massimo Franchini
principal investigator · ASST Mantova

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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