Study of Ruxolitinib Plus Simvastatin in the Prevention and Treatment of Respiratory Failure of COVID-19.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-12

Study Completion Date

2021-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ruxolitinib plus simvastatin

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.

Group Type EXPERIMENTAL

Ruxolitinib plus simvastatin

Intervention Type DRUG

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

Standard of Care

Patients will receive treatment according to usual clinical practice in the participant site.

Group Type OTHER

Standard of Care

Intervention Type OTHER

Patients will receive treatment according to usual clinical practice in the participant site.

Interventions

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Ruxolitinib plus simvastatin

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

Intervention Type DRUG

Standard of Care

Patients will receive treatment according to usual clinical practice in the participant site.

Intervention Type OTHER

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No