Official Title
Efficacy and Safety of Early Anti-SARS-COV-2 Convalescent Plasma in Patients Admitted for COVID-19 Infection: a Randomized Phase II Trial
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.

Completed
Severe Acute Respiratory Syndrome Coronavirus 2

Biological: COVID-19 convalescent plasma

COVID-19 convalescent plasma

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Chile
Locations

Hospital Clínico Universidad Católica
Santiago, Chile

Maria Elvira Balcells, MD, Principal Investigator
ebalcells@uc.cl

Fundacion Arturo Lopez Perez
NCT Number
Keywords
plasma
Covid-19
Severe acute respiratory syndrome coronavirus 2
MeSH Terms
COVID-19
Coronavirus Infections
Severe Acute Respiratory Syndrome