Hospital Universitario Madrid Sanchinarro
Madrid, 28050, Spain
NCT Number: NCT04348695
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 begins. This route is one of the therapeutic targets for which available drugs are being investigated in order to treat COVID-19 infection. This is one of the mechanisms blocked by drugs like ruxolitinib and chloroquine.
Various drugs approved for clinical use that block the clathrin-mediated endocytosis pathway have been explored. It has been found that the best in vitro and in vivo results were obtained with statins, which also allowed generating a greater potent adaptive immune response.
Therefore, statins and specifically simvastatin make it possible to block the entry process used by COVID-19, block inflammation by various mechanisms and increase the adaptive immune response. All of these processes are desirable in patients infected with COVID-19.
Statins have been proposed to have beneficial effects in patients infected with MERS-COV, another coronavirus similar to COVID-19, but there have been no randomized studies supporting the use of statins in patients with COVID-19 infection.
In this project we propose the combined use of one of these drugs, ruxolitinib with simvastatin, looking for a synergistic effect in the inhibition of viral entry and in the anti-inflammatory effect.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 2
Madrid, 28050, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ruxolitinib 5 mg orally every 12 hours for 7 days, which will be increased to 10 mg every 12 hours for a total of 14 days.
Simvastatin 40 mg orally every 24 hours for 14 days
Patients will receive treatment according to usual clinical practice in the participant site.
Time frame: 7 days
Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID at day 7 from randomization.
Time frame: 14 days
Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID at day 14 from randomization.
Time frame: 28 days
Time from ICU admision to ICU discharge.
Time frame: 28 days
Time from hospital admision to hospital discharge.
Time frame: 6 months
Percentage of patients alive at 6 months
Time frame: 12 months
Percentage of patients alive at 12 months
Time frame: 28 days
Percentage of patients who died from any cause 28 days after inclusion in the study
Time frame: 28 days
Percentage of patients with each AE by grade in relation with total number of treated patients
Time frame: 28 days
Percentage of patients who discontinued due to AEs in relation with total number of treated patients
Fundación de investigación HM
Other
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.
Acronym: Ruxo-Sim-20
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04483973
COVID-19, Corona Virus Infection
New Haven, Connecticut, United States
View Trial DetailsNCT04376034
COVID-19, Coronaviridae Infections
Morgantown, West Virginia, United States
View Trial DetailsNCT04427280
COVID-19, Cancer
Sutton, Surrey, United Kingdom
View Trial DetailsNCT04335084
COVID, COVID-19
Ventura, California, United States
View Trial Details