A Randomised Open-Label Trial of Early, Very High-Titre Convalescent Plasma Therapy in Clinically Vulnerable Individuals with Mild COVID-19

Phase 3

Completed

• Conditions: corona virus; COVID-19; SARS-CoV-2; 10027665; 10047438; 10024970

• Registration Number: NL-OMON51772
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-06-28
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Overall:
- SARS-CoV-2 RNA detected in a specimen, <= 7 days after onset of symptoms
- Symptoms of COVID-19
- Clinical status not requiring admission to hospital for COVID-19 disease and
oxygen support
- Ability to transfuse (per randomisation) within 7 days after onset of symptoms
- Signed written informed consent

Additional to cohort 1:
Men or women, 70 years or older OR under 70 years with significant
comorbidities resulting in a COVID-age of 70 years or more according to the
ALAMA risk calculator.

Additional to cohort 2:
Men or women, >=18 years of age with extremely high risk. Including patients
with acquired immune deficiencies OR primary lymphoid immune deficiencies OR
without detectable seroconversion >= 3 weeks after complete vaccination schedule
with an approved vaccine.

Exclusion Criteria

Overall:
- Age < 16 years
- Prior or concurrent treatment for COVID-19 (unless listed as authorized
specific treatment in protocol)
- History of documented SARS-CoV-2 infection in the last 90 days prior to
enrollment
- Contraindication to receiving convalescent plasma including previous history
of transfusion-related acute lung injury (TRALI) or moderate or severe allergic
reaction to blood components
- Known participant objection to receiving plasma products
- Refusal to participate expressed by patient or legally authorised
representative
- Pregnancy

Additional to cohort 1:
- Prior anti-SARS-CoV-2 immunization
- Primary or acquired immune deficiency listed below (see cohort 2)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of participants with (1) at least one overnight stay in hospital for<br /><br>progressive COVID-19 symptoms , or (2) who died, by day 28 after<br /><br>randomisation. </p><br>