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

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

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

Study Overview

• Status: Completed
• Conditions: Coronavirus Disease 2019 )COVID-19)
• Intervention / Treatment: Biological: COVID-19 Convalescent Plasma

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Italy
  • Chieti, Italy, 66100
    • Ospedale SS Annunziata
  • Rome, Italy, 00149
    • Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
  • RM
    • Roma, RM, Italy, 00168
      • Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Convalescent plasma; Patients receive COVID-19 Convalescent Plasma (CCP) in addition to standard therapy	Biological: COVID-19 Convalescent Plasma; ABO matched pathogen-inactivated CCP is transfused at a dose of 200 ml/day for 3 days (days 1, 2, and 3).; Other Names: CCP
No Intervention: Standard therapy; Patients receive standard therapy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of COVID-19 progression	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	days 1 to 14.

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

General Publications

• Teofili L, Landolfi R, Cingolani A, Antinori A, Vecchiet J, Sanguinetti M, Gasbarrini A, Pasciuto T, Orlando N, Lamonica S. "Early transfusion of convalescent plasma in older patients with COVID-19 to prevent disease progression: A structured summary of a study protocol for a randomised controlled trial". Trials. 2020 Oct 22;21(1):875. doi: 10.1186/s13063-020-04821-1.

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2020
• Primary Completion (Actual): May 26, 2021
• Study Completion (Actual): May 26, 2021

Study Registration Dates

• First Submitted: May 2, 2020
• First Submitted That Met QC Criteria: May 2, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Disease Progression
• Other Study ID Numbers: 3205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No