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:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT04431466
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of infection by SARS-CoV-2:
1. symptoms of acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath) and biomolecular diagnosis of SARS-CoV-2 infection; OR
2. any acute respiratory disease AND biomolecular diagnosis of SARS-CoV-2 infection; OR
3. severe acute respiratory infection (fever and at least one sign / symptom of respiratory disease eg cough, fever, shortness of breath) AND in need of hospitalization AND biomolecular diagnosis of SARS-CoV-2 infection;
* Eastern Cooperative Oncology Group Performance Status score 0 to 1;
* National Early Warning Score 0 to 4;
* Ability to understand and consent to participate in this clinical trial, manifested by signing the Informed Consent Form (ICF).
Exclusion Criteria:
* Inability to ingest / absorb the study drug orally through spontaneous ingestion or use of gastro / enteral tubes;
* Any finding of clinical observation (history / physical evaluation) that is interpreted by the investigating physician as a risk to participate in the trial;
* Any laboratory test findings that the investigating physician considers as a risk to the research participant as to his / her participation in the clinical study;
* Any ECG examination finding that the investigating physician considers as a risk to the research participant as to his / her participation in the trial;
* Known hypersensitivity to the components of the drugs used during the study;
* Women in pregnancy or breastfeeding;
* Body weight less than 15kg;
* Estimated glomerular filtration rate (CKD-Epidemiology Collaboration, CKD-EPI) \<30 mL / min;
* Aspartate aminotransaminase (AST) or alanine aminotransaminase (ALT)\> 5 times the upper limit of normality;
* Refusal to participate;
* Refusal to sign the informed consent form.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04431466
Study Brief:
Protocol Section:
NCT04431466