COVID-19 Convalescent Plasma
BiologicalABO matched pathogen-inactivated CCP is transfused at a dose of 200 ml/day for 3 days (days 1, 2, and 3).
Other names: CCP
NCT Number: NCT04374526
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
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Notify Me65 year and older
All sexes
Interventional
Phase 2 / Phase 3
Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, RM, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ABO matched pathogen-inactivated CCP is transfused at a dose of 200 ml/day for 3 days (days 1, 2, and 3).
Other names: CCP
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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Early transfusIon of COVID-19 Convalescent Plasma in Elderly COVID-19 Patients to Prevent Disease Progression.
Acronym: LIFESAVER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.