Convalescent Plasma Therapy from Recovered Patients to Treat COVID-19 Early in SARS-CoV-2 Disease

Phase 3

Recruiting

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

• Registration Number: NL-OMON49795
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 690

Inclusion Criteria

• PCR-confirmed COVID-19
• Symptomatic (e.g but not limited to fatigue, fever, cough, dyspnoe, loss of
taste or smell, diarrhea, falls or confusion)
• 70 years or older OR 50-69 years and 1 or more of the risk factors described
in table 1

Table 1:
1. A/ Medical history
• Obesity with BMI 35 or higher
• Born as a male person
• History of cardiac or pulmonary disease (e.g. but not limited to atrial
fibrillation, coronary artery disease, heart failure, COPD, asthma)
• History of neurological disease (e.g. a history of stroke or any other
chronic debilitating neurological disease)
• Diabetes for which medical therapy is needed
• Chronic kidney disease with GFR <60 ml/min
• Reumatic disease (e.g. reumatoid arthritis, Systemic lupus erythematosus,
psoriatric artritis)
• Immunodeficiency (e.g. organ or allogeneic transplantation, systemic
immunosuppressive drugs)
• Cancer not in complete remission for >1 year (excluding baso -or
spinocellular skin cancers)
• Untreated HIV and CD4 T-cells <200/microliter
• Chronic liver disease, liver cirrhosis

1. B/ Lab results (if available)
• CRP > 30
• SARS-CoV-2 RT-PCR Ct value <25

Exclusion Criteria

• Life expectancy <28 days in the opinion of the treating physician
• Patient or legal representative is unable to provide written informed consent
• Symptomatic for 8 days or more
• Being admitted to the hospital at the informed consent procedure
• Known previous history of transfusion-related acute lung injury
• Known IgA deficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Highest disease status on the 5-point ordinal disease severity scale in the<br /><br>28 days following transfusion of convP versus FFP.<br /><br><br /><br>Disease status is measured with a 5-point ordinal scale in which<br /><br>1 = Fully recovered (no symptoms) within 7 days after transfusion<br /><br>2 = Continued symptoms attributable to COVID-19 on day 7 after transfusion<br /><br>3 = Admitted to hospital but no invasive ventilation needed<br /><br>4 = Admitted to hospital and invasive ventilation needed<br /><br>5 = Death</p><br>