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

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ClinicalTrials.gov Identifier: NCT04374526
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 )COVID-19) Biological: COVID-19 Convalescent Plasma Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 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
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : June 30, 2021

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 Name: CCP

No Intervention: Standard therapy
Patients receive standard therapy alone



Primary Outcome Measures :
  1. Rate of COVID-19 progression [ Time Frame: 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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374526


Contacts
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Contact: Raffaele Landolfi, Prof. 06 30154435 ext +39 raffaele.landolfi@unicatt.it
Contact: Luciana Teofili, Prof. 06 30154180 ext +39 luciana.teofili@unicatt.it

Locations
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Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS Recruiting
Roma, RM, Italy, 00168
Contact: Raffaele Landolfi, Prof.    0630154335 ext +39    raffaele.landolfi@unicatt.it   
Sub-Investigator: Luciana Teofili         
Sub-Investigator: Antonella Cingolani         
Sub-Investigator: Maurizio Sanguinetti         
Ospedale SS Annunziata Not yet recruiting
Chieti, Italy, 66100
Contact: Jacopo Vecchiet, Prof.    0871 357217 ext +39    jacopo.vecchiet@unichi.it   
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani Not yet recruiting
Rome, Italy, 00149
Contact: Andrea Antinori, Prof.    06 55170348 ext +39    andrea.antinori@inmi.it   
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT04374526    
Other Study ID Numbers: 3205
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes