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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT04332094
Eligibility Criteria:
Inclusion Criteria:
* Subject (or authorized legal representative) who can provide written informed consent before beginning any study procedure.
* Understand and agree to abide by the study procedures.
* Adult #18 years of age at the time of inclusion in the study.
* Confirmation of SARS-CoV-2 infection by a microbiological test performed before randomization, no longer than 72 hours.
* Severity 3-4 according to the WHO 7-point ordinal scale.
Exclusion Criteria:
* ALT / AST\> 5 times the normal limit
* Stage 4 chronic kidney disease (GFR \<30) or requiring dialysis.
* Presence of comorbidities that imply a poor prognosis (according to clinical judgment).
* Advanced dementia.
* Pregnancy or breastfeeding.
* Anticipation of transfer to another center in the 12 hours at the beginning of the study.
* Allergy to study medication.
* Serious or active bacterial infections or documented sepsis by pathogens other than SARS-CoV-2.
* Streptococcus pneumoniae antigenuria positive before study start.
* Neutropenia \<500 / mm3.
* Thrombocytopenia \<100,000 / mm3.
* History of diverticulosis.
* Ongoing skin infection (eg, pyodermitis).
* Transplanted patient under immunosuppressive treatment.
* Previous evidence of latent untreated tuberculosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04332094
Study Brief:
Protocol Section:
NCT04332094