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.

INTERVENTION: Trade Name: Jakavi Product Name: ruxolitinib Pharmaceutical Form: Tablet INN or Proposed INN: RUXOLITINIB CAS Number: 1092939‐17‐7 Other descriptive name: RUXOLITINIB PHOSPHATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Product Name: Simvastatin Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: SIMVASTATIN Other descriptive name: SIMVASTATIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ CONDITION: COVID19 ; MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862 Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: Patients achieving a grade 5 or higher of the WHO 7‐point ordinal scale of severity categorization for COVID. Primary end point(s): 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.; ‐ Length of stay in ICU of those patients who finally require it; ‐ Length of hospital stay; ‐ Describe the safety profile of the study combination after 7 and 14 days of treatment.; ‐ Describe the percentage of patients alive at 6 and 12 months of the patients under study.; ‐ Describe the percentage of patients who died from any cause 28 days after inclusion in the study. Timepoint(s) of evaluation of this end point: 7 days SECONDARY OUTCOME: 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. ; ‐ Length of stay in ICU of those patients who finally require it ; ‐ Length of hospital stay ; ‐ Describe the safety profile of the study combination after 7 and 14 days of treatment. ; ‐ Describe the percentage of patients alive at 6 and 12 months of the patients under study. ; ‐ 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 ; ‐ 28 days ; ‐ 28 days ; ‐ 7 & 14 days ; ‐ 6 & 12 months ; ‐ 28 days 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 t