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OpenTrials
Completed

NCT Number: NCT04569188

Convalescent Plasma in COVID-19 Elderly Patients

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Transfusion Service

Mantua, 46100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Convalescent Plasma

Biological

COVID-19 elderly patients treated with convalescent plasma

Primary outcomes

  1. Death

    Time frame: 15 days

    Death from any cause

Secondary outcomes

  1. Viral load

    Time frame: 7 days

    Naso-pharyngeal swab

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale di Mantova

Other

Registry information

Official study title

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

Acronym: RESCUE

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 29, 2020
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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