Spanish Version
DATA SHEET
CLINICAL TRIAL REGISTRATION (EC)
EC INS No:  PER-030-20
1. ORGANIZATION / APPLICANTE INSTITUTION
Name of Organization / Institution: NOVARTIS BIOSCIENCES PERÚ S.A.   Type of Organization / Institution : Empresa / Compañia 
Legal Domicile : Jr. Juan de Arona 151, Oficinas 601-602 
District: San Isidro  Province: San Isidro 
Departament: LIMA 
Single Taxpayer No : 20100129028 
Telephone: 2006400   Fax: 2006400 
2. CLINICAL TRIAL GENERAL INFORMATION
Scientific title:
PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RUXOLITINIB IN PATIENTS WITH COVID-19 ASSOCIATED CYTOKINE STORM (RUXCOVID)


Public Title
PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RUXOLITINIB IN PATIENTS WITH COVID-19 ASSOCIATED CYTOKINE STORM (RUXCOVID)


Clinical Trial Registration Date Most recent Clinical Trial Update
22/07/2020  
Principal Sponsor :
1.- NOVARTIS PHARMA AG.  
Secondary Sponsor :
 
Funding Source
1.-  NOVARTIS BIOSCIENSES PERÚ S.A.
Executing Company / Institution / Other
- NOVARTIS BIOSCIENCES PERÚ S.A. Authorized with   N° 247-2020-OGITT/INS Date 22/07/2020
Responsabilities
 
  Others
NOVARTIS BIOSCIENCES PERÚ S.A.  
  Inform to the OGITT of the NIH when the first subject is enrolled in Peru, and the end date of enrollment in the country.
  Submit progress reports to the National Health Institute during the execution of the Clinical Trial.
  Submit to the OGITT of the NIH the final reports as well as the results, conclusions, and publication of the clinical trial
  Notify to the OGITT of the NIH the adverse events and deviations as established in the Clinical Trials Regulation.
  Inform and describe the reasons for a suspension and cancellation of the clinical trial.
  Provide the facilities for the inspection of the execution of the clinical trial by the staff of the General Office of Research and Technology Transfer (OGITT) of the National Institute of Health.
Study clinical phase: III  Protocol Code CINC424J12301 
Secondary ID(s) :  
WHO UTN: NA
CLINICALTRIALS.GOV: NCT04362137
EUDRACT N°:2020-001662-11
Study Design
This is a phase 3, randomized, double-blind, placebo-controlled, 29-day, multi-center study to assess the efficacy and safety of ruxolitinib + standard of care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 pneumonia. Participants, investigator staff, persons performing the assessments, and clinical trial team will remain blind to the identity of the treatment from the time of randomization until database lock. 
Insurance policy due date 01/07/2021  Assignation method Randomized 
Non randomized 
Type of blinding Assignation
Simple  Double  Triple 
Open
Single arm        Parallel
Crossed                 Factorial
Others:
Purpose
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of patients with COVID-19 pneumonia. The primary objective is to evaluate the efficacy (as measured by a composite endpoint of proportion of patients who die, develop respiratory failure [require mechanical ventilation], or require intensive care unit [ICU] care) of ruxolitinib + standard-of-care (SoC) therapy compared with placebo + SoC therapy, for the treatment of COVID-19 by Day 29. 
Research Product Information
Name of the product Generic Name Type of product ATC
RUXOLITINIB Ruxolitinib      R07
Name of the compare Generic Name Type of product ATC
PLACEBO Placebo      R07
Intervention(s) description:
Group name Type of group N° of participants Intervention(s) description
Ruxolitinib 5 mg + standard of care Experimental
Control
40   One ruxolitinib 5 mg tablet will be administered orally twice per day approximately 12 hours apart in addition to the standar of care treatment for 14 days. Additional 14 days of study drug may be given in the opinion of the investigator. If a patient becomes intubated during the course of the study, study drug can be administered through a nasogastric tube.
Placebo + standard of care Experimental
Control
20   One ruxolitinib matching placebo tablet will be administered orally twice per day approximately 12 hours apart in addition to the standar of care treatment for 14 days. Additional 14 days of study drug may be given in the opinion of the investigator.. If a patient becomes intubated during the course of the study, placebo treatment can be administered through a nasogastric tube.
Inclusion Criteria
"1. Signed informed consent. 2. Male and female patients aged ≥ 12 years. 3. Patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or another rapid test. 4. Patient is currently (or will be) hospitalized. 5. Patients, who meet at least one of the below criteria: • Pulmonary infiltrates (chest X ray or chest CT scan); • Respiratory frequency ≥ 30/min; • Requiring supplemental oxygen; • Oxygen saturation ≤ 94% on room air; • Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg"  
Exclusion Criteria
"1. Hypersensitivity to any drugs/metabolites as ruxolitinib. 2. Presence of severely impaired renal function. 3. Suspected uncontrolled, active bacterial, fungal, viral, or other infection. 4. Current or history of active TB infection. 5. History of progressive multifocal leukoencephalopathy. 6. Intubated between screening and randomization. 7. In ICU at time of randomization. 8. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs. 9. Intubated or in ICU for COVID-19 disease prior to screening. 10. Participating in any other investigational trials. 11. Unable to ingest tablets at randomization. 12. ALT ≥ 5 x ULN at screening. 13. Evidence of liver cirrhosis (Child A to C). 14. ANC < 1000/μL at screening. 15. Platelet count < 50,000/μL at screening. 16. Pregnant or nursing (lactating) women. 17. Females of childbearing potential unless the use of highly effective contraception method. 
Worldwide enrolment start date 03/05/2020 
Enrolment start date in Peru (Initial) 03/08/2020  Enrolment start date in Peru 27/08/2020 
Peru enrolment status Without starting enrollment
Enrollment stopped
  In enrollment
  Enrollment closed 
Clinical Trial Total Duration 12  months Medical Speciality INFECTOLOGY 
Studied Condition (CIE-10 code) -B342 Coronavirus infection, unspecified site  
Number of subjects to be included in all the countries 402 
Number of subjects to be included in Peru (initial) Number of subjects to be included in Peru (posterior)
60 60
Countries where the enrolment is conducted :
- Germany - Spain - France
- Italy - United Kindgdom - Russian Federation
- Argentina - Brazil - Canada
- Colombia - Mexico - Peru
- United States
Number of participants per gender (Initial) Female: 0 
Male : 0 
Number of participants per gender (Posterior) Female: 0 
Male : 0
Range of age of subjects to be included : - Adults (18-64 years) Yes   No
- Elderly (>= 65 years) Yes   No
- Under 18 years Yes   No
  If yes, specify:
  - In Utero Yes  No
  - Preterm newborn infants (up to gestational age < 37 weeks) Yes  No
  - Newborns (0-27 días) Yes  No
  - Infants and toddlers (28 days-23 months) Yes  No
  - Children (2 - 11 years) Yes  No
  - Adolescents (12 - 17 years) Yes  No
Subjects' treatment time 14  day(s) Subjects' follow up time 15  day(s)
Primary Outcome  
Name of the outcome Metric or method of measurement Time point for the outcome
Clinical failure, defined as the occurrence of death, respiratory failure (require mechanical ventilation), or ICU care by Day 29 "Proportion of subjects developing clinical failure by Day 29 with ruxolitinib + SoC versus placebo + SoC therapy. The odds of clinical failure will be analyzed by a logistic regression model with treatment group, region, baseline clinical status based on the 9-point ordinal scale, age, and gender as covariates." Day 29  
Secondary Outcome
Name of the outcome Metric or method of measurement Time point for the outcome
Oxygen saturation The proportion of patients with no oxygen therapy (defined as oxygen saturation ≥ 94% on room air) will be analyzed separately using a logistic regression model with the same covariates as for the primary analyses, with baseline oxygen therapy status included. Day 15 and Day 29  
In-hospital outcomes Duration of hospitalization will be analyzed using a competing risk analysis framework. Day 15 and Day 29  
National Early Warning Score (NEWS2) Time to discharge or to a National Early Warning Score (NEWS2) of ≤2 and maintained for 24 hours (whichever comes first) will be analyzed using a competing risk analysis framework. Day 15 and Day 29  
Safety endpoints Se evaluarán los eventos adversos, signos vitales y evaluaciones de laboratorio Day 29  
9-category ordinal scale The odds of observing a better category (lower number) of clinical status (9-category ordinal scale) at Day 15 will be analyzed with a proportional odds model (POM). The analysis will be repeated for the data at Day 29. Day 15 and Day 29  
3. RESEARCH SITE, PRINCIPAL INVESTIGATOR, ETHICS COMMITTEE
Research site where the clinical trial will be conducted Principal Investigator Institutional Research Ethics Committee (CIEI) that approved the trial for the site Observations
Research Institution RCI Research site Full name RCEI Ethics Committe Name Status Approval date End approval date Term Telephone number Email addrees
CLÍNICA INTERNACIONAL S.A. RCI 307 Unidad de Investigación de la Clínica Internacional
ALFREDO GILBERTO GUERREROS BENAVIDES

RCEI-305 COMITÉ NACIONAL TRANSITORIO DE ÉTICA EN INVESTIGACIÓN PARA LA EVALUACIÓN Y SUPERVISIÓN DE ÉTICA DE LOS ENSAYOS CLÍNICOS DE LA ENFERMEDAD COVID-19 - CNTEIApproved 23/06/2020 23/06/202007126450  
Co-Investigator
 
CLÍNICA RICARDO PALMA RCI-1136 THORAX
ENRIQUE RENZO MORELLO BUSTIOS


RCEI-305  COMITÉ NACIONAL TRANSITORIO DE ÉTICA EN INVESTIGACIÓN PARA LA EVALUACIÓN Y SUPERVISIÓN DE ÉTICA DE LOS ENSAYOS CLÍNICOS DE LA ENFERMEDAD COVID-19 - CNTEI Approved 11/07/2020  11/07/2021    - Research Site Extension R.D. 272-2020-OGITT-INS with date 04/08/2020  
Co-Investigator
 
CLÍNICA PROVIDENCIA RCI-392 CENTRO DE INVESTIGACIÓN DE ENFERMEDADES CARDIOVASCULARES
ROGER MARTIN CORREA FLORES


RCEI-305  COMITÉ NACIONAL TRANSITORIO DE ÉTICA EN INVESTIGACIÓN PARA LA EVALUACIÓN Y SUPERVISIÓN DE ÉTICA DE LOS ENSAYOS CLÍNICOS DE LA ENFERMEDAD COVID-19 - CNTEI Approved 11/07/2020  11/07/2021    - Research Site Extension R.D. 271-2020-OGITT-INS with date 04/08/2020  
Co-Investigator
 
HOSPITAL NACIONAL HIPÓLITO UNANUE RCI-542 HOSPITAL NACIONAL HIPÓLITO UNANUE
PABLO ESAÚ TORRES ESCALANTE


RCEI-305  COMITÉ NACIONAL TRANSITORIO DE ÉTICA EN INVESTIGACIÓN PARA LA EVALUACIÓN Y SUPERVISIÓN DE ÉTICA DE LOS ENSAYOS CLÍNICOS DE LA ENFERMEDAD COVID-19 - CNTEI Approved 11/07/2020  11/07/2021    - Research Site Extension R.D. 372-2020-OGITT/INS with date 07/09/2020  
Co-Investigator
 
COMPLETION DATE: 19/10/2020
4. IPD SHARING STATEMENT
Is there a plan for sharing of deidentified individual clinical trial participant-level data (IPD) to other researchers (including data dictionaries)?
Yes   No Non decided
In case the answer is affirmative, describe the Plan.
 
Additional information that will be shared. Study protocol
Statistical Analysis Plan
Informed Consent Form
Clinical Study report
Others: ________________
Describe briefly when this information will be available and how it can be obtained
 
URL NA
5. CLINICAL TRIAL CONTACT PERSONS INFORMATION
Full Name E-mail Telephone Type of queries to be resolved
Information to general public Administrative Consultations Scientific Consultations
Cecilia Ynouye Furuya cecilia.ynouye@novartis.com 511 2006400 Yes Yes
José Martin Ortiz Rodas jose.ortiz@novartis.com 511 2006400 Yes
AUTHORIZATION STATUS
AUTHORIZED    ACTIVE
TYPE AND NUMBER OF AUTHORIZATION   DOCUMENT R.D.  N° 247-2020-OGITT/INS AUTHRORIZATION   DOCUMENT DATE (dd/mm/aaaa): 22/07/2020  (Validity date from:22/07/2020)
SUMMARY EVALUATION REPORT
APPROVED PROCEDURES
TYPE OF PROCEDURE TYPE AND NUMBER OF RESOLUTION / OFFICIAL LETTER DATE OF RESOLUTION / OFFICIAL LETTER VALIDITY DATE ANNULATION
FROM

TO

 

Research Site Extension
R.D. 272-2020-OGITT-INS
04/08/2020

Research Site Extension
R.D. 271-2020-OGITT-INS
04/08/2020

Clinical Trial Amendment Report
 827-2020-OGITT-INS
18/08/2020

Clinical Trial Amendment Report
 875-2020-OGITT-INS
27/08/2020

Clinical Trial Amendment Report
 936-2020-OGITT-INS
07/09/2020

Research Site Extension
R.D. 372-2020-OGITT/INS
07/09/2020

Clinical Trial Amendment Report
 1001-2020-OGITT-INS
16/09/2020

Clinical Trial Progress Report
 
22/10/2020 11:14:16 a.m.

Clinical Trial Progress Report
 
22/10/2020 11:14:35 a.m.

Clinical Trial Progress Report
 
22/10/2020 11:14:59 a.m.

Clinical Trial Progress Report
 
23/10/2020 12:48:09 p.m.

Clinical Trial Progress Report
 
12/01/2021 12:24:49 p.m.

Clinical Trial Progress Report
 
12/01/2021 12:25:02 p.m.

Clinical Trial Progress Report
 
12/01/2021 12:25:13 p.m.

Clinical Trial Progress Report
 
12/01/2021 12:25:26 p.m.

Research Center Final Report
 
22/03/2021 10:34:38 a.m.

Research Center Final Report
 
22/03/2021 10:34:56 a.m.

Research Center Final Report
 
22/03/2021 10:42:50 a.m.

Clinical Trial National Final Report
 
10/04/2021 03:30:04 p.m.