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Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19 (RUXO-COVID)

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ClinicalTrials.gov Identifier: NCT04477993
Recruitment Status : Terminated (Low accrual)
First Posted : July 20, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Vanderson Geraldo Rocha, University of Sao Paulo General Hospital

Brief Summary:
The COVID-19 pandemic has had a dramatic effect in public health worldwide. In Brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since February 26, 2020. Based on reports of a hyperinflammatory state associated with COVID-19, the use of immunosuppressive drugs may be efficacious in the treatment of this disease. JAK inhibitors have been shown to harness inflammation in a number of different pathologic conditions. The aim of the present study is to evaluate the efficacy and safety of JAK inhibitor ruxolitinib in patients with acute respiratory distress syndrome due to COVID-19.

Condition or disease Intervention/treatment Phase
Severe Acute Respiratory Syndrome Coronavirus 2 SARS-CoV2 Drug: Janus Kinase Inhibitor (ruxolitinib) Other: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind Clinical Trial of Ruxolitinib in Patients With Acute Respiratory Disorder Syndrome Due to SARS-CoV-2 Infection
Actual Study Start Date : August 14, 2020
Actual Primary Completion Date : March 29, 2021
Actual Study Completion Date : March 29, 2021


Arm Intervention/treatment
Experimental: Experimental Group - ruxolitinib
Ruxolitinib 5 mg PO b.i.d. for 14 days
Drug: Janus Kinase Inhibitor (ruxolitinib)
5 mg P.O. b.i.d. for 14 days. Dose reduction will occur if neutrophils < 500/mm3 or platelets <50,000/mm3.

Placebo Comparator: Placebo Group Other: Placebo
Placebo tablets P.O. b.i.d. for 14 days.




Primary Outcome Measures :
  1. A composite outcome of death or ICU admission or mechanical ventilation at day 14. [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. A composite outcome of death or ICU admission or mechanical ventilation at day 28 [ Time Frame: 28 days ]
  2. Time to treatment failure [ Time Frame: 28 days ]
    ICU admission, mechanical ventilation, death or consent withdrawal

  3. Overall survival at days 14 and 28 [ Time Frame: 14 and 28 days ]
  4. Cumulative incidence of ICU admission rate at days 14 and 28 [ Time Frame: 14 and 28 days ]
  5. Cumulative incidence of mechanical ventilation at days 14 and 28 [ Time Frame: 14 and 28 days ]
  6. Duration of hospital stay [ Time Frame: 28 days ]
  7. Duration of ICU stay [ Time Frame: 28 days ]
  8. Duration of mechanical ventilation [ Time Frame: 28 days ]
  9. Duration of non-invasive ventilation [ Time Frame: 28 days ]
  10. Secondary hemophagocytic syndrome rate [ Time Frame: 28 days ]
  11. Cumulative incidence nosocomial infection rate at days 14 and 28 [ Time Frame: 14 and 28 days ]
  12. Incidence of discontinuation of oxygen supplementation at days 14 and 28 [ Time Frame: 14 and 28 days ]
  13. Rate of grade 1-2 and 3-5 emerging adverse events at day 28 [ Time Frame: 28 days ]
  14. Cumulative dose of methylprednisolone at days 14 and 28 [ Time Frame: 14 and 28 days ]
  15. Change in PaO2/FiO2 ratio from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  16. Change in interleukin 6 levels [pg/mL] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  17. Change in d-dimer levels [ng/mL] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  18. Change in fibrinogen levels [mg/dL] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  19. Change in ferritin levels [ng/mL] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  20. Change in C reactive protein levels [mg/L] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  21. Change in alanine aminotransferase [U/L] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  22. Change in aspartate aminotransferase [U/L] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  23. Change in creatinine levels [mg/dL] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  24. Change in glucose levels [mg/dL] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  25. Change in hemoglobin levels [g/dL] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  26. Change in platelet count [x10ˆ3/mmˆ3] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  27. Change in absolute neutrophil count [x10ˆ3/mmˆ3] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  28. Change in absolute neutrophil count [/mmˆ3] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  29. Change in absolute lymphocyte count [/mmˆ3] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  30. Change in prothrombin time ratio from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  31. Change in partial thromboplastin time ratio from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  32. Change in bilirubin [mg/dl] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  33. Change in lactate dehydrogenase [U/L] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  34. Change in CPK-MB [ng/mL] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  35. Change in troponin [ng/mL] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  36. Change in von Willebrand factor antigen level (VWF:Ag) [%] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  37. Change in von Willebrand factor activity (ristocetin cofactor) [%] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  38. Change in ADAMTS-13 [%] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  39. Change in von Willebrand multimeters from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  40. Change in plasminogen activator inhibitor-1 levels [ng/mL] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  41. Change in E-selectin levels [ng/mL] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  42. Change in P-selectin levels [ng/mL] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  43. Change in endothelin [fmol/mL] from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  44. Change in circulating microparticles from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]
  45. Change in thromboelastography from baseline to days 14 and 28 [ Time Frame: 14 and 28 days ]


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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients hospitalized with SARS-CoV-2 pneumonia confirmed by RT-PCR or serology (IgA);
  • PaO2/FiO2 < 300 (not fully explained by heart failure or volume overload) or SpO2 < 90% on room air.

Exclusion Criteria:

  • Symptom onset > 14 days;
  • Neutrophil count < 1,000/mm3;
  • Platelets < 50,000/mm3;
  • ICU care at enrollment;
  • On invasive mechanical ventilation at enrollment;
  • Current use of experimental therapy for COVID-19 (except: azithromycin or corticosteroids)
  • Uncontrolled arterial hypertension;
  • Current or previous use of systemic immunosuppressive therapy in the last 30 days;
  • Pregnancy or lactation;
  • Estimated creatinine clearance < 30 mL/min or receiving CRRT or intermittent hemodialysis;
  • Allergy to ruxolitinib;
  • Active tuberculosis;
  • HIV seropositivity;
  • Prior history of progressive multifocal leukoencephalopathy;
  • Use of any JAK inhibitor in the last 30 days before study enrollment;
  • Not qualifying according to investigators' perception.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04477993


Locations
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Brazil
Hospital das Clínicas
Sao Paulo, Brazil, 05403-000
Sponsors and Collaborators
Vanderson Geraldo Rocha
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Responsible Party: Vanderson Geraldo Rocha, Full Professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04477993    
Other Study ID Numbers: 32894720.3.0000.0068
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vanderson Geraldo Rocha, University of Sao Paulo General Hospital:
SARS-CoV2
Severe Acute Respiratory Syndrome Coronavirus 2
Janus Kinase Inhibitors
Safety
Clinical Efficacy
Clinical Trial
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiration Disorders
Respiratory Tract Diseases
Syndrome
Disease
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action