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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04374526
Recruitment Status : Completed
First Posted : May 5, 2020
Last Update Posted : May 28, 2021
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)
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

Resource links provided by the National Library of Medicine


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


Locations
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Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, Italy, 00168
Ospedale SS Annunziata
Chieti, Italy, 66100
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
Rome, Italy, 00149
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 28, 2021
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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COVID-19
Disease Progression
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes