Convalescent Plasma in COVID-19 Elderly Patients

COVID-19 Clinical Trial

— RESCUE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04569188
• Other study ID #: Asstmantova
• Status: Completed
• Phase: Phase 2
• Start date: May 15, 2020
• Est. completion date: September 3, 2020

Study information

• Verified date: September 2020
• Source: Azienda Socio Sanitaria Territoriale di Mantova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 3, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Convalescent plasma
COVID-19 elderly patients treated with convalescent plasma

Locations

Country	Name	City	State
Italy	Transfusion Service	Mantova

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Socio Sanitaria Territoriale di Mantova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Death from any cause	15 days
Secondary	Viral load	Naso-pharyngeal swab	7 days