PHASE 2 STUDY OF EFFICACY AND SAFETY OF PLASMA FROM CONVALESCENT PATIENTS WITH COVID-19 IN PATIENTS WITH MODERATE DISEASE (AUNA 20-01)

Not Applicable

Conditions: -B342 Coronavirus infection, unspecified site
Coronavirus infection, unspecified site
B342

Registration Number: PER-031-20

Lead Sponsor: ONCOSALUD S.A.C.,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 0

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Disease progression towards severe COVID 19 (ICU admission) up to 14 days after the first plasma administration.<br>Progression to severe phase will be considered as any person with acute respiratory infection, with two or more of the following criteria:<br>- Respiratory rate> 22 breaths per minute or PaCO2 <32mmHg.<br>-Alteration of the level of consciousness<br>- Systolic blood pressure less than 100 mmHg or MAP <65 mmHg.<br>- PaO2 <60 mmHg or PaFi <300.<br>- Clinical signs of muscle fatigue: nasal flutter, use of accessory muscles, toro-abdominal imbalance.<br>- Serum lactate> 2 mosm / L.<br>Measure:Moderate phase progression to severe phase<br>Timepoints:Up to 14 days after the first plasma administration.<br>

Secondary Outcome Measures