Clinical trial NCT04374526: Early transfusIon of Convalescent Plasma in Elderly COVID-19 Patients. to Prevent Disease Progression.
Official title: Early transfusIon of COVID-19 Convalescent Plasma in Elderly COVID-19 Patients to Prevent Disease Progression.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronavirus Disease 2019 )COVID-19)
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 29
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Rate of COVID-19 progression
timeFrame: days 1 to 14.
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
city: Chieti
country: Italy
facility: Ospedale SS Annunziata
city: Rome
country: Italy
facility: Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
Study officials:
References:
citation: 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.