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Efficacy and Safety of Early COVID-19 Convalescent Plasma in Patients Admitted for COVID-19 Infection

Phase 2
Completed
Conditions
Severe Acute Respiratory Syndrome Coronavirus 2
Registration Number
NCT04375098
Lead Sponsor
Pontificia Universidad Catolica de Chile
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
58
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization1 year follow up
Secondary Outcome Measures
NameTimeMethod
30-day mortality (percentage)1 year follow up
Hospital mortality rate (percentage)1 year follow up
Median duration of fever1 year

Days

Median duration of mechanical ventilation1 year follow up

Days

Median length of ICU stay1 year follow up

Days

Median length of admission1 year follow up

Days

Readmission rate (percentage)1 year follow up
Median length of viral clearance1 year follow up

days

Trial Locations

Locations (1)

Hospital Clínico Universidad Católica

🇨🇱

Santiago, Chile

Hospital Clínico Universidad Católica
🇨🇱Santiago, Chile

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