B342 Coronavirus infection, unspecified site Coronavirus infection, unspecified site
Conditions
Interventions
None listed
Sponsors
ONCOSALUD S.A.C.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients of both sexes = 18 years - Patient with a confirmed diagnosis of COVID-19 using moderately classified nasal and pharyngeal swab PCR tests, with some of the following symptoms: Dyspnea or respiratory distress Respiratory rate> 22 breaths / min Arterial oxygen saturation <95% in ambient air Alteration of the level of consciousness Low blood pressure or shock Clinical and / or radiological signs of pneumonia Lymphocyte count less than 1000 cel / uL - Acceptance of participation by signing an informed consent. - That it is not participating in another interventional study for COVID-19.
Exclusion criteria
Exclusion criteria: - Patients with a history of previous transfusion allergic reaction. - Pregnant or lactating women (since there are no studies demonstrating their safety in pregnant and / or lactating women). - Patients who have received other types of immunoglobulin therapy in the previous 30 days. - Pediatric patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease progression towards severe COVID 19 (ICU admission) up to 14 days after the first plasma administration. Progression to severe phase will be considered as any person with acute respiratory infection, with two or more of the following criteria: - Respiratory rate> 22 breaths per minute or PaCO2 2 mosm / L. NAME OF THE RESULT: Moderate phase progression to severe phase PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Up to 14 days after the first plasma administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease progression towards severe COVID 19 (ICU admission) up to 14 days after the first plasma administration. Progression to severe phase will be considered as any person with acute respiratory infection, with two or more of the following criteria: - Respiratory rate> 22 breaths per minute or PaCO2 2 mosm / L. NAME OF THE RESULT: Moderate phase progression to severe phase PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Up to 14 days after the first plasma administration.;Defined as the number of days elapsed from the first dose to discharge. NAME OF THE RESULT: Discharge time. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Defined as the number of days elapsed from the first dose to discharge.;Defined as the absence or presence of dyspnea NAME OF THE RESULT: Dyspnoea PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From the first dose to discharge or 60 days from the administration of the first dose of the investigational product.;Defined as the presence of the following criteria: Absence of dyspnea or respiratory distress Respiratory rate from 16 to 22 resp / min Arterial oxygen saturation = 95% Absence of altered level of consciousness Absence of low blood pressure or shock, Absence of clinical and / or radiological signs of pneumonia Lymphocyte count = 1000 cel / u. NAME OF THE RESULT: Recovery PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: After the administration of the first dose until discharge or 60 days from the administration of the first dose of the investigational product.;Defined as the number of days elapsed from the first dose to withdrawal of the oxygen supply for clinical improvement. NAME OF THE RESULT: Dependency time of oxygen administration PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OB | — |
Countries
Peru
Outcome results
None listed