Convalescent Plasma in COVID-19 Elderly Patients

NCT04569188 | Completed Phase 2 DMC

• 1 other identifier: Asstmantova
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Death

  Death from any cause

  15 days

Secondary Outcomes (1)

• Viral load

  7 days

Study Arms (1)

convalescent plasma

EXPERIMENTAL

Cohort of elderly patients treated with convalescent plasma

Biological: Convalescent plasma

Interventions

Convalescent plasma BIOLOGICAL

COVID-19 elderly patients treated with convalescent plasma

convalescent plasma

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale di Mantova: lead

Study Sites (1)

Transfusion Service

Mantova, 46100, Italy

Location

Related Publications (1)

• 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.

  PMID: 33585799 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Massimo Franchini

  ASST Mantova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Immunohematology and Transfusion Service

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 29, 2020
• Study Start: May 15, 2020
• Primary Completion: August 15, 2020
• Study Completion: September 3, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-09

Locations

IT (1)