EUCTR2020-001405-23-ES
Active, not recruiting
Phase 1
Randomized phase II clinical trial of ruxolitinib plus simvastatin in the prevention and treatment of respiratory failure of COVID-19.Ruxo-Sim-20 clinical trial. - Ruxo-Sim-20
Fundación de Investigación HM Hospitales0 sites94 target enrollmentApril 13, 2020
ConditionsCOVID19MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsJakavi
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID19
- Sponsor
- Fundación de Investigación HM Hospitales
- Enrollment
- 94
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Clinical trial of ruxolitinib in combination with nilotinib and prednisona for myelofibrosis: RuNiC studyMyeloproliferative DiseasesMedDRA version: 20.0Level: LLTClassification code 10074691Term: Post polycythaemia vera myelofibrosisSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2016-005214-21-ESGrupo Español de Enfermedades Mieloproliferativas GEMFI44
Active, not recruiting
Not Applicable
Study with ruxolitinib to evaluate efficacy and safety in Patients with Proliferative Chronic Myelomonocytic LeukemiaProliferative Chronic Myelomonocytic Leukemia (CMML)MedDRA version: 16.1Level: LLTClassification code 10054350Term: Chronic myelomonocytic leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2013-004370-10-ESGrupo Español de Sindromes Mielodisplásicos (GESMD)
Active, not recruiting
Phase 1
A Study of Ruxolitinib in Combination With Regorafenib in Subjects Metastatic Colorectal CancerRelapsed or refractory metastatic colorectal cancerMedDRA version: 17.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10010030Term: Colorectal cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2013-004714-18-GBIncyte Corporation420
Active, not recruiting
Phase 1
A Study of Ruxolitinib in Combination With Regorafenib in Subjects Metastatic Colorectal CancerTherapeutic area: Diseases [C] - Cancer [C04]Relapsed or refractory metastatic colorectal cancerMedDRA version: 17.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10010030Term: Colorectal cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-004714-18-ESIncyte Corporation420
Active, not recruiting
Phase 1
A Study of Ruxolitinib in Combination With Regorafenib in Subjects Metastatic Colorectal CancerRelapsed or refractory metastatic colorectal cancerMedDRA version: 17.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: PTClassification code 10010030Term: Colorectal cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2013-004714-18-ATIncyte Corporation427