Status:
COMPLETED
Study of Ruxolitinib Plus Simvastatin in the Prevention and Treatment of Respiratory Failure of COVID-19.
Lead Sponsor:
Fundación de investigación HM
Collaborating Sponsors:
Apices Soluciones S.L.
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
COVID-19's mechanism to enter the cell is initiated by its interaction with its cellular receptor, the angiotensin-converting enzyme. As a result of this union, a clathrin-mediated endocytosis process...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04348695
Start Date
April 12 2020
End Date
January 31 2021
Last Update
June 6 2022
Active Locations (1)
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1
Hospital Universitario Madrid Sanchinarro
Madrid, Spain, 28050