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

Pontificia Universidad Catolica de Chile

Status and phase: Completed; Phase 2

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2

Treatments: Biological: COVID-19 convalescent plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04375098

200415015

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Early COVID-19 convalescent plasma

Experimental group

Description:

COVID-19 convalescent plasma 200 ml day 1 and 2 at admission after confirmation of eligibility

Treatment:

Biological: COVID-19 convalescent plasma

COVID-19 convalescent plasma

Experimental group

Description:

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

Treatment:

Biological: COVID-19 convalescent plasma