Early transfusIon of Convalescent Plasma in Elderly COVID-19 Patients. to Prevent Disease Progression.

Phase 2

Completed

• Conditions: Coronavirus Disease 2019 )COVID-19)
• Interventions: Biological: COVID-19 Convalescent Plasma

• Registration Number: NCT04374526
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

Older age is an independent poor outcome predictor among COVID-19 hospitalized patients . Among 72,314 COVID-19 cases, case fatality rate (CFR) was 2.3% in total population, 8% in people aged 70 to 79, and 14.8% in those aged 80 and older. In the whole population, CFR was higher in people with comorbidities, ranging from 5-6% in persons with hypertension, chronic respiratory disease, diabetes or cancer, up to 10% in those with cardiovascular diseases. Sars-CoV-2 seems to be able to induce a functional exhaustion of specified T and NK lymphocyte subpopulations, breaking down antiviral immunity. One possible explanation is that the immune system of elderly people, might be exhausted by chronic stimulation associated with comorbidities and more susceptible to this Sars-CoV-2 effect. As a result, in these patients, the activation of the innate immune system might fail to produce an adequate adaptive response (i.e., virus-specific CD8+ T-cells). This results in persistent self-induced inflammation that eventually causes mortality.

The investigators hypothesize that transfusing convalescent plasma (containing neutralizing antibodies) at an early phase of COVID-19 infection could prevent or switch off the persistent inflammatory response elicited by the virus.

The objective of this study are:

* To demonstrate the superiority of COVID-19 convalescent plasma (CCP) plus standard therapy (ST) over ST alone

* To prevent progression of pneumonia in COVID-19 patients aged ≥65 with chronic comorbidities

* To decrease viral load

* To raise anti-SARS-CoV-2 antibody titer in recipients

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-02
• Study First Submitted QC: 2020-05-02
• Study First Posted: 2020-05-05
• Study Start: 2020-05-27
• Primary Completion: 2021-05-26
• Study Completion: 2021-05-26
• Last Update Submitted: 2021-05-27
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Age ≥ 65
• pneumonia at CT scan
• PaO2/FiO2 ≥300 mmHg
• Presence of one or more comorbidities (consider the list provided in Appendix A)
• Signed informed consent

Exclusion Criteria

• Age < 65
• PaO2/FiO2 < 300 mmHg
• pending cardiopulmonary arrest
• refusal to blood product transfusions
• Severe IgA deficiency
• any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Convalescent plasma	COVID-19 Convalescent Plasma	Patients receive COVID-19 Convalescent Plasma (CCP) in addition to standard therapy

Primary Outcome Measures

Name	Time	Method
Rate of COVID-19 progression	days 1 to 14.	Proportion of patients without progression in severity of pulmonary disease defined as worsening of 2 points in the ordinal scale of WHO within day 14

Trial Locations

Locations (3)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, RM, Italy

Ospedale SS Annunziata; 🇮🇹 Chieti, Italy

Istituto Nazionale Malattie Infettive Lazzaro Spallanzani; 🇮🇹 Rome, Italy