Biomarker-based Early Anti-inflammatory Therapy for severe COVID-19

Completed

• Conditions: Coronavirus infection; COVID-19; 10047438; 10024970

• Registration Number: NL-OMON55200
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 275

Inclusion Criteria

hospitalized patients
- Hospitalized patient with PCR confirmed COVID-19 infection
- Eighteen years or older
healthy volunteers
- Not-hospitalized
- Sixty years or older
- Sars-CoV-2 serology negative
mild infection
- Positive SARS-CoV-2 PCR test from the GGD
- No or limited symptoms of a viral airway infection (fever, cough, dyspnea,
rhinorroea, myalgia, anosmia) at the time of inclusion
- Age 18 years or older

Exclusion Criteria

Patients and healthy controls
- Not able to give consent by the healthy volunteer, or the patient or patients
representative

Healthy controls
- Symptoms of viral airway infection (e.g. fever, cough, rhinorroea,
dyspnea) at screening or inclusion

Group of infected individuals with little or no symptoms:
- Having received vaccination against SARS-CoV-2 or previous confirmed
infection with SARS-CoV-2.
- Not being able to come to LUMC by own transportation to donate samples.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is the identification of pro-inflammatory biomarkers in the<br /><br>development of acute severe lung injury and multi-organ failure in infection<br /><br>with SARS-CoV-2 </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>See protocol section 8.1.2 Secondary study parameters/endpoints</p><br>