Spanish Version
DATA SHEET
CLINICAL TRIAL REGISTRATION (EC)
EC INS No:  PER-042-20
1. ORGANIZATION / APPLICANTE INSTITUTION
Name of Organization / Institution: GLAXOSMITHKLINE PERÚ S.A.   Type of Organization / Institution : Laboratorio (Industria Farmacéutica) 
Legal Domicile : Javier Prado Oeste 995, San Isidro 
District: San Isidro  Province: Lima 
Departament: Lima 
Single Taxpayer No : 20100123682 
Telephone: 211-9700   Fax: 211 9719 
2. CLINICAL TRIAL GENERAL INFORMATION
Scientific title:
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY EVALUATING THE EFFICACY AND SAFETY OF OTILIMAB IV IN PATIENTS WITH SEVERE PULMONARY COVID-19 RELATED DISEASE


Public Title
INVESTIGATING OTILIMAB IN PATIENTS WITH SEVERE PULMONARY COVID-19 RELATED DISEASE


Clinical Trial Registration Date Most recent Clinical Trial Update
21/08/2020  
Principal Sponsor :
1.- GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED  
Secondary Sponsor :
 
Funding Source
1.-  GLAXOSMITHKLINE PERÚ S.A.
Executing Company / Institution / Other
- GLAXOSMITHKLINE PERÚ S.A. Authorized with   324-2020-OGITT-INS Date 21/08/2020
Responsabilities
 
  Others
GLAXOSMITHKLINE 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: II  Protocol Code 214094 
Secondary ID(s) :  
WHO UTN: NA
CLINICALTRIALS.GOV: NA
EUDRACT N°:2020-01759-42
Study Design
This study is a multi-center, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. The study population consists of hospitalized participants with new onset hypoxia requiring significant oxygen support or requiring invasive mechanical ventilation (≤48 hours before dosing). All participants will receive standard of care as per institutional protocols, in addition to study treatment. 
Insurance policy due date 31/12/2021  Assignation method Randomized 
Non randomized 
Type of blinding Assignation
Simple  Double  Triple 
Open
Single arm        Parallel
Crossed                 Factorial
Others:
Purpose
To compare the efficacy of otilimab 90 mg IV versus placebo. 
Research Product Information
Name of the product Generic Name Type of product ATC
OTILIMAB Otilimab      L03
Name of the compare Generic Name Type of product ATC
PLACEBO DE OTILIMAB Placebo de Otilimab      V03
Intervention(s) description:
Group name Type of group N° of participants Intervention(s) description
Otilimab Experimental
Control
400   Participants receive a blinded 1-hour infusion of Otilimab 90 mg IV in addition to standard of care.
Otilimab placebo Experimental
Control
400   Participants receive a blinded 1-hour infusion of Otilimab placebo 90 mg IV in addition to standard of care.
Inclusion Criteria
1) Age ≥18 years and ≤79 years 2) Have positive SARS-CoV-2 result 3) Be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan) 4) Be developing new onset of oxygenation impairment requiring any of the following: high-flow oxygen (≥15L/min); non-invasive ventilation (e.g. CPAP, iPAP); mechanical ventilation ≤48h prior to dose 5) Have increased biological markers of systemic inflammation. 6) No gender restriction 7) Female participants must meet and agree to abide by the contraceptive criteria. 8) Capable of giving written informed consent. If participants are not capable of giving written informed consent, alternative consent procedures. For more details check the protocol  
Exclusion Criteria
1) Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator. 2) Multiple organ failure according to the investigator’s judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU 3) Extracorporeal membrane oxygenation (ECMO) hemofiltration/dialysis, or high dose (>0.15ug/kg/min) noradrenaline (or equivalent) or more than one vasopressor 4) Current serious or uncontrolled medical condition or abnormality of clinical 5) Untreated systemic bacterial, fungal, viral, or other infection 6) Known active tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB 7) Known HIV regardless of immunological status 8) Known HBsAg and/or anti-HCV positive 9) Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy 10) Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, JAK inhibitors within the last 3 months prior to randomization 11) Received monoclonal antibody therapy (e.g. tocilizumab, sarilumab) within the past 3 months prior to randomization 12) History of allergic reaction, including anaphylaxis to any previous treatment with an anti-GM-CSF therapy For more details check the protocol  
Worldwide enrolment start date 28/05/2020 
Enrolment start date in Peru (Initial) 01/08/2020  Enrolment start date in Peru 08/10/2020 
Peru enrolment status Without starting enrollment
Enrollment stopped
  In enrollment
  Enrollment closed 
Clinical Trial Total Duration 15  months Medical Speciality PNEUMOLOGY 
Studied Condition (CIE-10 code) -J128 Other viral pneumonia  
Number of subjects to be included in all the countries 800 
Number of subjects to be included in Peru (initial) Number of subjects to be included in Peru (posterior)
35 35
Countries where the enrolment is conducted :
- India - Japan - Belgium
- Spain - France - Poland
- United Kindgdom - Sweden - Nederland
- South Africa - Argentina - Brazil
- Canada - Chile - 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 1  day(s) Subjects' follow up time 2  month(s)
Primary Outcome  
Name of the outcome Metric or method of measurement Time point for the outcome
To compare the efficacy of otilimab 90 mg IV versus placebo To compare the efficacy of otilimab 90 mg IV versus placebo 28 days 
Secondary Outcome
Name of the outcome Metric or method of measurement Time point for the outcome
All-cause mortality at Day 60 All-cause mortality at Day 60 60 days 
Time to all-cause mortality up to Day 60 Time to all-cause mortality up to Day 60 60 days 
Participants alive and free of respiratory failure at Day 7, 14, 42, and 60 Participants alive and free of respiratory failure at Day 7, 14, 42, and 60 60 days 
Time to recovery from respiratory failure up to Day 28 Time to recovery from respiratory failure up to Day 28 28 days 
Participants alive and independent of supplementary oxygen at Day 7, 14, 28, 42, and 60 Participants alive and independent of supplementary oxygen at Day 7, 14, 28, 42, and 60 60 days 
Time to last dependence on supplementary oxygen up to Day 28 Time to last dependence on supplementary oxygen up to Day 28 28 days 
Admission to ICU up to Day 28 Admission to ICU up to Day 28 28 days 
Time to final ICU discharge up to Day 28 Time to final ICU discharge up to Day 28 28 days 
Time to final hospital discharge up to Day 28 Time to final hospital discharge up to Day 28 28 days 
Occurrence of adverse events (AEs) [up to Day 60] Occurrence of adverse events (AEs) [up to Day 60] 60 days 
Occurrence of serious adverse events (SAEs) [up to Day 60] Occurrence of serious adverse events (SAEs) [up to Day 60] 60 days 
Invasive mechanical ventilation (if not previously initiated) Invasive mechanical ventilation (if not previously initiated) 28 days 
Time to invasive mechanical ventilation (if not previously initiated) Time to invasive mechanical ventilation (if not previously initiated) 28 days 
Alive and not invasively mechanically ventilated Alive and not invasively mechanically ventilated 28 days 
Time to definitive extubation Time to definitive extubation 28 days 
Improvement of at least 2 points relative to baseline of Sequential Organ Failure Assessment (SOFA) score Improvement of at least 2 points relative to baseline of Sequential Organ Failure Assessment (SOFA) score 28 days 
Improvement relative to baseline in SpO2, FiO2, and SpO2/FiO2 ratio Improvement relative to baseline in SpO2, FiO2, and SpO2/FiO2 ratio 28 days 
Oxygen-free days Oxygen-free days 28 days 
Ventilator-free days Ventilator-free days 28 days 
Time to resolution of pyrexia (for at least 48h) Time to resolution of pyrexia (for at least 48h) 28 days 
Clinical status assessed using an ordinal scale assessed at Days 4, 7, 14, 28, 42, and 60. Clinical status assessed using an ordinal scale assessed at Days 4, 7, 14, 28, 42, and 60. 60 days 
Time to improvement of at least 2 categories relative to baseline on an ordinal scale Time to improvement of at least 2 categories relative to baseline on an ordinal scale 60 days 
Change in COVID-19 signs and symptoms Change in COVID-19 signs and symptoms 60 days 
Otilimab apparent clearance (CL/F) and other PK parameters as appropriate using sparse PK sampling Otilimab apparent clearance (CL/F) and other PK parameters as appropriate using sparse PK sampling 14 days 
Exposure-response relationship for key efficacy, safety and PD endpoints Exposure-response relationship for key efficacy, safety and PD endpoints 28 days 
Key markers of inflammation including, but not limited to CRP, serum ferritin and inflammatory cytokines as appropriate Key markers of inflammation including, but not limited to CRP, serum ferritin and inflammatory cytokines as appropriate 28 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 NACIONAL ALBERTO SABOGAL SOLOGUREN DE LA RED ASISTENCIAL SABOGAL RCI 78 Unidad de Investigación, Hospital Nacional IV Alberto Sabogal Sologuren, Essalud, Red Asistencial Sabogal
LUIS ENRIQUE HERCILLA VASQUEZ

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 27/07/2020 26/07/2021127126450  
Co-Investigator
- Erika Cecilia Agurto Lescano
 
HOSPITAL NACIONAL EDGARDO REBAGLIATI MARTINS RCI-403 UNIDAD DE INVESTIGACIÓN DE INFECTOLOGÍA 1
FERNANDO CRUZ MENDO URBINA


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 07/08/2020  07/08/2021    - Research Site Extension R.D. 356-2020-OGITT-INS with date 02/09/2020

- Clinical Trial Research Site Closure Resolución Directoral223-2021-OGITT-INS with date27/05/2021  
Co-Investigator
 
CLÍNICA INTERNACIONAL S.A. RCI-307 UNIDAD DE INVESTIGACIÓN DE LA CLÍNICA INTERNACIONAL
JOSÉ LUIS CABRERA RIVERO


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 07/08/2020  07/08/2021    - Research Site Extension R.D. 358-2020-OGITT-INS with date 02/09/2020  
Co-Investigator
 
HOSPITAL MILITAR CENTRAL “LUIS ARIAS SCHEREIBER” RCI-301 CENTRO DE INVESTIGACIÓN DEL HOSPITAL MILITAR CENTRAL
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 17/08/2020  07/08/2021    - Research Site Extension R.D. 357-2020-OGITT-INS with date 02/09/2020  
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
 
URL https://ensayosclinicos-repec.ins.gob.pe/
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
José Carlos Sandoval Okuma jose.c.sandoval@gsk.com 995954846 Yes Yes Yes
AUTHORIZATION STATUS
AUTHORIZED    ACTIVE
TYPE AND NUMBER OF AUTHORIZATION   DOCUMENT R.D.  324-2020-OGITT-INS AUTHRORIZATION   DOCUMENT DATE (dd/mm/aaaa): 21/08/2020  (Validity date from:21/08/2020)
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. 356-2020-OGITT-INS
02/09/2020

Research Site Extension
R.D. 358-2020-OGITT-INS
02/09/2020

Research Site Extension
R.D. 357-2020-OGITT-INS
02/09/2020

Clinical Trial Progress Report
R.D. 
17/11/2020 09:39:51 a.m.

Clinical Trial Progress Report
R.D. 
17/11/2020 09:40:13 a.m.

Clinical Trial Progress Report
R.D. 
17/11/2020 09:40:36 a.m.

Clinical Trial Progress Report
R.D. 
17/11/2020 09:40:59 a.m.

Clinical Trial Progress Report
R.D. 
18/02/2021 10:35:42 a.m.

Clinical Trial Progress Report
R.D. 
18/02/2021 11:25:38 a.m.

Clinical Trial Progress Report
R.D. 
18/02/2021 11:32:41 a.m.

Clinical Trial Progress Report
R.D. 
18/02/2021 04:18:53 p.m.

Research Center Final Report
R.D. 
21/05/2021 04:45:07 p.m.

Clinical Trial Progress Report
R.D. 
25/05/2021 07:07:25 p.m.

Clinical Trial Progress Report
R.D. 
25/05/2021 07:07:47 p.m.

Clinical Trial Research Site Closure
R.D. 223-2021-OGITT-INS
27/05/2021

Research Center Final Report
R.D. 
21/10/2021 05:36:13 p.m.