Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT04577534
Eligibility Criteria:
Inclusion Criteria:
* written informed consaent obtained
* hospitalized with COVID-19 disease
* Age \>/= 18 years
* SARS CoV-2 NhO posit
* Sp=2 \</93% on ambient air or respiratory rate \>30 /min
* Any 2 of the 4: P-IL-6 \> 2 x ULN / P-ferritin \> 2 x ULN / P-FIDD \>1.5 mg/l / P- CRP \>40 mg/l without obvious presence of bacterial infection (normal values: P -IL-6 \<5.9 ng/l; P-ferritin, men 30-400 mikrog/l, women 13-150 mikrog/l ; P-FIDD (Fibrin degradation products, D-dimer) \<0.5 mg/l; P-CRP \<10 mg/l)
Exclusion Criteria:
* Known severe allergic reactions to monoclonal antibodies
* Active confirmed tuberculosis with ongoing treatment or obvious tuberculosis or obvious other bacterial, fungal or viral infection (besides COVID-19)
* In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
* Long-term oral anti-rejection or immunomodulatory drugs (including corticosteroids equivalent to methylprednison 15mg/day)
* Pregnant or lactating women. If needed, exclusion of pregnancy should be performed by laboratory test (U-hCG-O).
* Participating in other drug clinical trials
* Absolute neutrophil count \< 1 x10E9/l
* Platelet count \<50 x10E9/l
* ALAT \>10x ULN
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04577534
Study Brief:
Protocol Section:
NCT04577534