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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Completed
CT.gov ID
NCT04374526
Collaborator
(none)
29
Enrollment
3
Locations
2
Arms
12
Actual Duration (Months)
9.7
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Biological: COVID-19 Convalescent Plasma
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Early transfusIon of COVID-19 Convalescent Plasma in Elderly COVID-19 Patients to Prevent Disease Progression.
Actual Study Start Date :
May 27, 2020
Actual Primary Completion Date :
May 26, 2021
Actual Study Completion Date :
May 26, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione Policlinico Universitario A. Gemelli IRCCS Roma RM Italy 00168
    2 Ospedale SS Annunziata Chieti Italy 66100
    3 Istituto Nazionale Malattie Infettive Lazzaro Spallanzani Rome Italy 00149

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT04374526
    Other Study ID Numbers:
    • 3205
    First Posted:
    May 5, 2020
    Last Update Posted:
    May 28, 2021
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Disease Progression

    Study Results

    No Results Posted as of May 28, 2021