Convalescent Plasma in COVID-19 Elderly Patients

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Biological: Convalescent plasma

• Registration Number: NCT04569188
• Lead Sponsor: Azienda Socio Sanitaria Territoriale di Mantova

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

Study Timeline

• Study Start: 2020-05-15
• Primary Completion: 2020-08-15
• Status Verified: 2020-09
• Study Completion: 2020-09-03
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-28
• Study First Posted: 2020-09-29
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
convalescent plasma	Convalescent plasma	Cohort of elderly patients treated with convalescent plasma

Primary Outcome Measures

Name	Time	Method
Death	15 days	Death from any cause

Secondary Outcome Measures

Name	Time	Method
Viral load	7 days	Naso-pharyngeal swab

Trial Locations

Locations (1)

Transfusion Service; 🇮🇹 Mantova, Italy