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

NCT ID: NCT04374526

Last Updated: 2021-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-27
• Study Completion Date: 2021-05-26

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

Conditions

Coronavirus Disease 2019 )COVID-19)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Convalescent plasma

Patients receive COVID-19 Convalescent Plasma (CCP) in addition to standard therapy

Group Type: EXPERIMENTAL

COVID-19 Convalescent Plasma

Intervention Type: BIOLOGICAL

ABO matched pathogen-inactivated CCP is transfused at a dose of 200 ml/day for 3 days (days 1, 2, and 3).

Standard therapy

Patients receive standard therapy alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BIOLOGICAL

Other Intervention Names

CCP

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy

Ospedale SS Annunziata

Chieti, , Italy

Istituto Nazionale Malattie Infettive Lazzaro Spallanzani

Rome, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 33092632 (View on PubMed)

Other Identifiers

3205

Identifier Type: -

Identifier Source: org_study_id