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

Study Overview
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Brief Summary
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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

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

Conditions
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Coronavirus Disease 2019 )COVID-19)

Intervention / Treatment
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* Biological: COVID-19 Convalescent Plasma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Convalescent plasma<br>Patients receive COVID-19 Convalescent Plasma (CCP) in addition to standard therapy | Biological: COVID-19 Convalescent Plasma<br>* ABO matched pathogen-inactivated CCP is transfused at a dose of 200 ml/day for 3 days (days 1, 2, and 3).<br>* Other names: CCP;|
| No Intervention: Standard therapy<br>Patients receive standard therapy alone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |