Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

Study Overview
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Brief Summary
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To determinate feasibility, safety and outcome with convalescent plasma in patients with severe COVID-19 penumonia

Detailed Description
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COVID-19 convalescent plasma will be infused to patients with severe COVID-19 pneumonia to determine feasibility, safety and clinical outcome efficacy by survival at-28 days. Data will be compared with match control arm patients without plasma infusion

Official Title
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Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

Conditions
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Covid19 Pneumonia

Intervention / Treatment
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* Biological: COVID19 convalescent plasma infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients ≥18, and non-pregnant women Severe or critical COVID-19 disease define by one or more of the following: blood oxygen saturation ≤ 94% on supplemental oxygen by nasal cannula at least 3 L/min, non-rebreathing mask (NRO2-mask) or on noninvasive ventilation; and pulmonary infiltrates with >50% increase within 24 to 48 hours in chest-X-ray or chest CT. Life-threatening disease was defined as one or more of the following: respiratory failure on mechanical ventilation with PaO2 / FiO2 less than 300 mm Hg, septic shock, and/or multiple organ dysfunction. 10 days from the onset of symptoms or ≤ 7 days on mechanical ventilation. - Exclusion Criteria: More than 10 days from symptoms onset or more than 7 days on mechanical ventilation Pregnancy Contraindication for plasma infusion because anaphylaxis history Patients with high risk of circulatory overload Limitation of therapeutic efforts Refractory shock define by norepinephrine dose more than 1 ug/k/min SOFA score more than 15 points at the moment of the protocol inclusion i Coagulopathy with requirements of plasma infusion

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: patients with severe COVID19 pneumonia will be recruited to a single arm therapy group with convalescent plasma from recovered patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: severe pneumonia arm<br>patients with severe COVID19 pneumonia defined by: spontaneous breathing patients with respiratory failure requiring O2 nasal cannula more than 3 L/min or reservoir oxygen mask and SaO2 less than 95% or patients with critical pneumonia define by mechanical ventilation with less than 300 mmHg PaO2/FiO2 or shock or multi-organic dysfunction | Biological: COVID19 convalescent plasma infusion<br>* intravenous infusion of 300-600 mL of convalescent plasma with an antibody title more than 3 according to chemiluminescent microparticle immunoassay (Architect Plus Abbott)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 days survival | number of subjects surviving at 28 days from plasma infusion | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of plasma infusion according to antibodies levels in the infuse bags | comparison of clinical efficacy according antibodies levels | 28 days | 
| clinical efficacy of plasma infusion according to frame time from symptoms onset and hospitalization | we will search if clinical efficacy is better when the earlier the infusion is decided | 28 days | 
| change in clinical WHO ordinal scale from 1 to 10 points | WHO clinical scale is a measure of patient progression through the health-care system with 1 point asymptomatic patient and 10 patient dead | 14 days |