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2. CLINICAL TRIAL GENERAL INFORMATION
Scientific title:
A RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TOCILIZUMAB IN HOSPITALIZED PATIENTS WITH COVID-19 PNEUMONIA
Public Title
A RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TOCILIZUMAB IN HOSPITALIZED PATIENTS WITH COVID-19 PNEUMONIA
Clinical Trial Registration Date
Most recent Clinical Trial Update
24/06/2020
Principal Sponsor :
1.- GENETECH, INC.
Secondary Sponsor :
Funding Source
1.- GENENTECH, INC.
Executing Company / Institution / Other
- PPD PERU S.A.C.
-
Authorized with 197-2020-OGITT-INS Date 24/06/2020
Responsabilities
PPD Peru S.A.C.
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
Inform and describe the reasons for a suspension and cancellation of the clinical trial.
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.
ROCHE FARMA (PERU) S.A.
Others
Notify to the OGITT of the NIH the adverse events and deviations as established in the Clinical Trials Regulation.
Study clinical phase:
III
Protocol Code
ML42528
Secondary ID(s) :
WHO UTN:
NA
CLINICALTRIALS.GOV:
NCT04372186
EUDRACT N°:
NA
Study Design
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of TCZ in combination with SOC compared with placebo in combination with SOC in hospitalized adult patients with COVID-19. The Sponsor intends to enroll approximately 379 patients that have been diagnosed with COVID-19 pneumonia and meet the entry criteria.
Insurance policy due date
01/01/2022
Assignation method
Randomized
Non randomized
Type of blinding
Assignation
Simple
Double
Triple
Open
Single arm
Parallel
Crossed
Factorial
Others:
Purpose
The primary efficacy objective for this study is to evaluate the efficacy of TCZ compared with placebo in combination with standard of care (SOC) for the treatment of COVID-19 pneumonia on the basis of the following endpoint: Cumulative proportion of patients with death or requiring mechanical ventilation by Day 28.
Research Product Information
Name of the product
Generic Name
Type of product
ATC
TOCILIZUMAB
TOCILIZUMAB
L04
Name of the compare
Generic Name
Type of product
ATC
TOCILIZUMAB PLACEBO
TOCILIZUMAB PLACEBO
V03
Intervention(s) description:
Group name
Type of group
N° of participants
Intervention(s) description
Tocilizumab (TCZ)
Experimental
Control
30
Participants will receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.
Tocilizumab Placebo
Experimental
Control
30
Participants will receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.
Inclusion Criteria
1) Documented informed consent by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative
2) Age 18 years
3) Ability to comply with the study protocol
4) Hospitalized
5) COVID-19 pneumonia confirmed per a positive PCR of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and radiographic imaging (CT scan or chest X-ray)
6) Able to complete screening within 96 hours of hospital admission.
7) Blood oxygen saturation (SpO2) 94% while on ambient air
8) For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
9) For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
Exclusion Criteria
1) Known severe allergic reactions to TCZ or other monoclonal antibodies
2) Active tuberculosis (TB) infection
3) Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
4) In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
5) Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past 3 months
6) Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
7) Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
8) Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (investigational COVID-19 antivirals may be permitted if approved by Medial Monitor)
9) Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator´s judgment, precludes the patient´s safe participation in and completion of the study
10) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab)
11) Absolute neutrophil count (ANC) < 1000/mL at screening (per local lab)
12) Platelet count < 50,000/mL at screening (per local lab)
Worldwide enrolment start date
09/06/2020
Enrolment start date in Peru (Initial)
21/06/2020
Enrolment start date in Peru
03/07/2020
Peru enrolment status
Without starting enrollment
Enrollment stopped
In enrollment
Enrollment closed
Clinical Trial Total Duration
17 months
Medical Speciality
INTERNAL MEDICINE
Studied Condition (CIE-10 code)
-J128 Other viral pneumonia
Number of subjects to be included in all the countries
379
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 :
- Kenya
- South Africa
- Brazil
- 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
1
day(s)
Subjects' follow up time
60 day(s)
Primary Outcome
Name of the outcome
Metric or method of measurement
Time point for the outcome
Cumulative proportion of patients with death or requiring mechanical ventilation by Day 28
The primary efficacy objective for this study is to evaluate the efficacy of TCZ plus SOC compared with placebo plus SOC. Time to death or the first utilization of mechanical ventilation after randomization will be compared between the TCZ group and the placebo group using the stratified log-rank test with age group (age 60, age 60 years) as the stratification factor. The cumulative proportion of patients with death or requiring mechanical ventilation at Day 28 will be estimated using the Kaplan-Meier method.
Day 28
Secondary Outcome
Name of the outcome
Metric or method of measurement
Time point for the outcome
Time to improvement in ordinal clinical status
Defined as time from randomization to the time when at least a 2-category improvement in the 7-category ordinal scale is observed. Assessment of patient status using an ordinal scale will be recorded at baseline and once daily in the morning (between approximately 8 am and 12 pm) while hospitalized.
60 days
Time to clinical failure
Defined as the time to first occurrence on study of death, mechanical ventilation, ICU admission, or withdrawal, whichever occurs first
For up to 60 days.
Mortality rate at Day 28
Difference in mortality rate at Day 28 will be compared using the Cochran-Mantel-Haenszel test statistic stratified by age group (age 60, age 60 years). The difference in proportions and its 95% CI for the treatment group comparison will be presented.
Day 28
Time to hospital discharge or “ready for discharge”
“Ready for discharge” defined as normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or 2L supplemental oxygen.
Up to 60 days.
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
HOSPITAL MILITAR CENTRAL "CORONEL LUIS ARIAS SCHEREIBER"
RCI 301
CENTRO DE INVESTIGACIÓN DEL HOSPITAL MILITAR
VICTORIA CHAVEZ MIÑANO
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
19/06/2020
18/06/2021
12
7126450
Co-Investigator
- Giovanna Rosa Trujillo Velita- Miluska Daniela Delgado Flores
HOSPITAL NACIONAL HIPÓLITO UNANUE
RCI-542
HOSPITAL NACIONAL HIPÓLITO UNANUE
JOHAN ALEXANDER AZAÑERO HARO
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
21/06/2020
21/06/2021
- Research Site Extension R.D. 208-2020-OGITT-INS with date 02/07/2020
Co-Investigator
HOSPITAL MARIA AUXILIADORA
RCI-260
CENTRO DE INVESTIGACIONES MÉDICAS - HOSPITAL MARÍA AUXILIADORA
MARIA ANGELICA PAREDES MORENO
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
21/06/2020
21/06/2021
- Research Site Extension R.D. 207-2020-OGITT-INS with date 02/07/2020
Co-Investigator
HOSPITAL CAYETANO HEREDIA
RCI-363
DEPARTAMENTO DE ENFERMEDADES INFECCIOSAS, TROPICALES Y DERMATOLÓGICAS
FERNANDO ALONSO MEJIA CORDERO
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
21/06/2020
21/06/2021
- Research Site Extension R.D. 206-2020-OGITT-INS with date 02/07/2020
Co-Investigator
HOSPITAL NACIONAL SERGIO E. BERNALES
RCI-105
CENTRO DE INVESTIGACIÓN EN ENFERMEDADES NEUMOLÓGICAS
EPIFANIO SANCHEZ GARAVITO
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
27/06/2020
27/06/2021
- Research Site Extension R.D. 215-2020-OGITT-INS with date 09/07/2020
Co-Investigator
COMPLETION DATE:
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
