Severe Acute Respiratory Syndrome Coronavirus 2
Conditions
Keywords
Plasma, COVID-19, severe acute respiratory syndrome coronavirus 2
Brief summary
Currently there is no standard treatment for SARS-CoV-2 infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including SARS-CoV-1 , MERS-CoV and Hantavirus infection. This study is an open-label randomized trial in which patients with high risk of COVID19-associated respiratory failure will be randomized to early treatment with convalescent plasma (≤ 7 days from symptoms start) or at early signs of respiratory failure or prolonged hospitalization. COVID-19 convalescent plasma will be collected from individuals according to the institutional protocol.
Interventions
BIOLOGICALCOVID-19 convalescent plasma
COVID-19 convalescent plasma
Sponsors
Fundacion Arturo Lopez Perez
Pontificia Universidad Catolica de Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient older than 18 years * CALL score ≥ 9 (progression risk score) * PCR-confirmed COVID-19 infection with equal or less than 7 days of symptoms (or imaging consistent with COVID-19 pneumonia and confirmed COVID-19 contact) * Any symptoms of COVID-19 infection * Admission due to COVID-19 infection * Signed informed consent * ECOG before COVID-19 infection 0-2
Exclusion criteria
* PaFi \<200 or mechanical ventilation indication * Clinically relevant co-infection at admission * Pregnancy or lactation * IgA deficiency or IgA nephropathy * Immunoglobulin or plasma administration in the last 60 days * Contraindication to transfusion or previous allergy to blood-derived products * Do-not-resuscitate status * Patients receiving other investigational drug for COVID-19 in a clinical trial * Any condition, that in opinion of the investigator may increase the risk associated with study participation or interfere with the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization | 1 year follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median duration of mechanical ventilation | 1 year follow up | Days |
| Median length of ICU stay | 1 year follow up | Days |
| Median length of admission | 1 year follow up | Days |
| Median duration of fever | 1 year | Days |
| 30-day mortality (percentage) | 1 year follow up | — |
| Readmission rate (percentage) | 1 year follow up | — |
| Median length of viral clearance | 1 year follow up | days |
| Hospital mortality rate (percentage) | 1 year follow up | — |
Countries
Chile
Outcome results
None listed