Convalescent Plasma in COVID-19 Elderly Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2020-09-03

Brief Summary

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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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Detailed Description

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

Conditions

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COVID-19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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convalescent plasma

Cohort of elderly patients treated with convalescent plasma

Group Type EXPERIMENTAL

Convalescent plasma

Intervention Type BIOLOGICAL

COVID-19 elderly patients treated with convalescent plasma

Interventions

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Convalescent plasma

COVID-19 elderly patients treated with convalescent plasma

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No