Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determinate feasibility, safety and outcome with convalescent plasma in patients with severe COVID-19 penumonia
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| severe pneumonia arm | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID19 convalescent plasma infusion | Biological | intravenous infusion of 300-600 mL of convalescent plasma with an antibody title more than 3 according to chemiluminescent microparticle immunoassay (Architect Plus Abbott) |
| Measure | Description | Time Frame |
|---|---|---|
| 28 days survival | number of subjects surviving at 28 days from plasma infusion | 28 days |
| 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 |
Not provided
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Educación Médica e Investigaciones Clínicas | Buenos Aires | 1425 | Argentina |
we will to share results to compare data with other studies with convalescent plasma infusion in COVID 19 patients after finishing our study
Not provided
Not provided
Not provided
Not provided
Not provided
patients with severe COVID19 pneumonia will be recruited to a single arm therapy group with convalescent plasma from recovered patients
Not provided
Not provided
Not provided
Not provided
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 |