Covid19 Pneumonia
Conditions
Brief summary
To determinate feasibility, safety and outcome with convalescent plasma in patients with severe COVID-19 penumonia
Detailed description
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
Interventions
BIOLOGICALCOVID19 convalescent plasma infusion
intravenous infusion of 300-600 mL of convalescent plasma with an antibody title more than 3 according to chemiluminescent microparticle immunoassay (Architect Plus Abbott)
Sponsors
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
patients with severe COVID19 pneumonia will be recruited to a single arm therapy group with convalescent plasma from recovered patients
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28 days survival | 28 days | number of subjects surviving at 28 days from plasma infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of plasma infusion according to antibodies levels in the infuse bags | 28 days | comparison of clinical efficacy according antibodies levels |
| clinical efficacy of plasma infusion according to frame time from symptoms onset and hospitalization | 28 days | we will search if clinical efficacy is better when the earlier the infusion is decided |
| change in clinical WHO ordinal scale from 1 to 10 points | 14 days | WHO clinical scale is a measure of patient progression through the health-care system with 1 point asymptomatic patient and 10 patient dead |
Countries
Argentina
Outcome results
None listed