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 @ 2:21 PM
Ignite Modification Date:
2025-12-24 @ 2:21 PM
NCT ID:
NCT04348695
Eligibility Criteria:
Inclusion Criteria:
* Patients who have given their written informed consent. If it is considered that obtaining written consent could constitute a factor for the transmission of the disease (given the high contagiousness of the SARS-Cov-2 virus), it will be permitted to obtain duly justified verbal consent in the patient's medical history.
* Clinical diagnosis or confirmed by analytical tests (PCR of viral RNA or detection of antiSARS-Cov-2 antibodies) that requires care in hospital and that are grade 3 or 4 of the WHO 7-point ordinal scale of severity categorization for COVID.
* Platelets\> 50,000 / uL, neutrophils\> 500 / ul
* Kidney or liver failure is not a contraindication, dose adjustment will be made according to the SmPC
* Women of childbearing potential who are sexually active, not undergoing a hysterectomy or double adnexectomy, should follow the following indications for contraception:
* Negative serum or urine pregnancy test in the 72 hours prior to the start of treatment.
* Use of a medically accepted contraceptive method during: 2 months prior to the start of study treatment, during the study and up to 3 months after the last dose of treatment.
Exclusion Criteria:
* Documented concomitant severe bacterial or fungal infection
* Infection with HIV, HCV, HBV
* Age \<18 years
* Thrombocytopenia \<50,000 / uL, Neutropenia \<500 / uL
* Women of childbearing age who do not use an effective contraceptive method.
* Pregnant or lactating women.
* Patients who do not want or cannot comply with the protocol.
* Patients with impaired gastrointestinal function or gastric disease that significantly impairs the absorption of ruxolitinib or simvastatin, such as: severe ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, extensive resection (\> 1m) of the small intestine or inability to swallow oral medication. Previous partial or total gastrectomy is not an exclusion criterion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04348695
Study Brief:
Protocol Section:
NCT04348695