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

Coronavirus Disease 2019 )COVID-19) Clinical Trial

— LIFESAVER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04374526
• Other study ID #: 3205
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 27, 2020
• Est. completion date: May 26, 2021

Study information

• Verified date: May 2020
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 26, 2021
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Disease 2019 )COVID-19)
• Disease Progression

Intervention

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).

Locations

Country	Name	City	State
Italy	Ospedale SS Annunziata	Chieti
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma	RM
Italy	Istituto Nazionale Malattie Infettive Lazzaro Spallanzani	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.