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
- Interventions
- Biological: COVID-19 convalescent plasma
- 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
- Arm && Interventions
Group Intervention Description Early COVID-19 convalescent plasma COVID-19 convalescent plasma COVID-19 convalescent plasma 200 ml day 1 and 2 at admission after confirmation of eligibility COVID-19 convalescent plasma COVID-19 convalescent plasma COVID-19 convalescent plasma 200 ml day 1 and 2 only if worsening of respiratory function or persistence of COVID symptoms for \>7 days after enrolment
- Primary Outcome Measures
Name Time Method Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization 1 year follow up
- Secondary Outcome Measures
Name Time Method 30-day mortality (percentage) 1 year follow up Hospital mortality rate (percentage) 1 year follow up Median duration of fever 1 year Days
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
Readmission rate (percentage) 1 year follow up Median length of viral clearance 1 year follow up days
Trial Locations
- Locations (1)
Hospital Clínico Universidad Católica
🇨🇱Santiago, Chile