Study of ruxolitinib plus simvastatin in the prevention and treatment of respiratory failure of COVID-19.
- Conditions
- COVID19MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001405-23-ES
- Lead Sponsor
- Fundación de Investigación HM Hospitales
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 94
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID.;Secondary Objective: - Percentage of patients who develop severe respiratory failure (grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID) in the first 14 days of participation in this study.<br>- Length of stay in ICU of those patients who finally require it<br>- Length of hospital stay<br>- Describe the safety profile of the study combination after 7 and 14 days of treatment.<br>- Describe the percentage of patients alive at 6 and 12 months of the patients under study.<br>- Describe the percentage of patients who died from any cause 28 days after inclusion in the study.;Primary end point(s): Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID.;Timepoint(s) of evaluation of this end point: 7 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Percentage of patients who develop severe respiratory failure (grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID) in the first 14 days of participation in this study.<br>- Length of stay in ICU of those patients who finally require it<br>- Length of hospital stay<br>- Describe the safety profile of the study combination after 7 and 14 days of treatment.<br>- Describe the percentage of patients alive at 6 and 12 months of the patients under study.<br>- Describe the percentage of patients alive at 6 and 12 months of the patients under study.;Timepoint(s) of evaluation of this end point: - 14 days<br>- 28 days<br>- 28 days<br>- 7 & 14 days<br>- 6 & 12 months<br>- 28 days