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

NCT04374526 | Completed Phase 2

• 1 other identifier: 3205
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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)

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Convalescent plasma

EXPERIMENTAL

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

Biological: COVID-19 Convalescent Plasma

Standard therapy

NO INTERVENTION

Patients receive standard therapy alone

Interventions

COVID-19 Convalescent Plasma BIOLOGICAL

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

Also known as: CCP

Convalescent plasma

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 65
• PaO2/FiO2 \< 300 mmHg
• pending cardiopulmonary arrest
• refusal to blood product transfusions
• Severe IgA deficiency

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (3)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

Location

Ospedale SS Annunziata

Chieti, 66100, Italy

Location

Istituto Nazionale Malattie Infettive Lazzaro Spallanzani

Rome, 00149, Italy

Location

Related Publications (1)

• 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.

  PMID: 33092632 DERIVED

MeSH Terms

Interventions

COVID-19 Serotherapy

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 5, 2020
• Study Start: May 27, 2020
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: May 28, 2021

Record last verified: 2020-05

Locations

IT (3)