Spanish Version
DATA SHEET
CLINICAL TRIAL REGISTRATION (EC)
EC INS No:  PER-018-20
1. ORGANIZATION / APPLICANTE INSTITUTION
Name of Organization / Institution: ASTRAZENECA PERU S.A.   Type of Organization / Institution : Puesto de Salud 
Legal Domicile : Av. El Derby Nº 055 Torre II oficina 503 
District: Santiago de Surco, Lima 33  Province: Lima 
Departament: Lima 
Single Taxpayer No : 20513645547 
Telephone: 610-1515   Fax: 718-7969 
2. CLINICAL TRIAL GENERAL INFORMATION
Scientific title:
A PHASE 2, OPEN LABEL, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF ACALABRUTINIB WITH BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE IN SUBJECTS HOSPITALIZED WITH COVID-19


Public Title
A PHASE 2, OPEN LABEL, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF ACALABRUTINIB WITH BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE IN SUBJECTS HOSPITALIZED WITH COVID-19


Clinical Trial Registration Date Most recent Clinical Trial Update
30/06/2020  
Principal Sponsor :
1.- ACERTA PHARMA, BV  
Secondary Sponsor :
1.- ASTRAZENECA PERÚ S.A.  
Funding Source
1.-  ACERTA PHARMA, BV
Executing Company / Institution / Other
- ASTRAZENECA PERU S.A. Authorized with   204-2020-OGITT-INS Date 30/06/2020
Responsabilities
 
  Others
ASTRAZENECA PERU 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 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 D822FC00001/ACE-ID-201 
Secondary ID(s) :  
WHO UTN: N/A
CLINICALTRIALS.GOV: NCT04346199
EUDRACT N°:2020-001644-25
Study Design
This is a multicenter, randomized, open-label, Phase 2 study that will evaluate acalabrutinib plus BSC versus BSC in subjects with COVID-19 who are hospitalized. Subjects will be randomly assigned (1:1) to receive one of the following 2 treatments: Clinical Study Protocol - 3.0 AstraZeneca Acalabrutinib - ACE-ID-201 (D822FC00001) CONFIDENTIAL AND PROPRIETARY 16 of 88 • Arm 1: Acalabrutinib 100 mg twice daily (bid) x 10 days + BSC (n=70) • Arm 2: BSC alone (n=70) For the purpose of this study, BSC is per discretion of the Investigator and institutional guidelines. However, refer to Section 5.2 and Section 6.5.3 for prohibited or restricted concomitant therapy. Subjects will be randomized based on the following stratification factors, which are considered prognostic factors for poor outcome: • Age (≥ 65 vs < 65 years) • Comorbidities (present vs absent). “Present” is defined as having at least 1 of the following comorbidities: − Cardiovascular disease, as defined by either heart failure New York Heart Association class ≥2 or hypertension requiring treatment − Diabetes mellitus requiring treatment − Chronic obstructive pulmonary disease or asthma requiring treatment − Current active solid tumor or hematologic malignancy Inclusion/exclusion criteria are provided in Section 5. Assessments are provided in Table 1. 
Insurance policy due date 26/02/2021  Assignation method Randomized 
Non randomized 
Type of blinding Assignation
Simple  Double  Triple 
Open
Single arm        Parallel
Crossed                 Factorial
Others:
Purpose
The overall objective of the study is to evaluate the efficacy of adding acalabrutinib to BSC for the treatment of COVID-19  
Research Product Information
Name of the product Generic Name Type of product ATC
ACALABRUTINIB (ACP-196) Acalabrutinib (ACP-196)  RESEARCH PRODUCT ORIGEN QUIMIC    L01
Intervention(s) description:
Group name Type of group N° of participants Intervention(s) description
Arm 1 Experimental
Control
70   Patients will receive Acalabrutinib 100 mg VO twice daily (BID) per 10 days plus the best supportive care during the time at the discretion of the investigator and institutional guidelines.
Arm 2 Experimental
Control
70   Patients will receive only the best supportive care during the time at the discretion of the investigator and institutional guidelines.
Inclusion Criteria
Subjects are eligible to be included in the study only if all of the criteria below apply. 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations). Clinical Study Protocol - 3.0 AstraZeneca Acalabrutinib - ACE-ID-201 (D822FC00001) CONFIDENTIAL AND PROPRIETARY 26 of 88 2. Men and women ≥18 years of age at the time of signing the Informed Consent Form (ICF). 3. SARS-CoV-2 confirmed per World Health Organization (WHO) criteria (including positive nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 4 days of randomization. 4. COVID-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen. 5. Able to swallow pills. 6. Willing to follow contraception guidelines (refer to Appendix F).  
Exclusion Criteria
Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms; endstage cardiac disease; cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days; endstage lung disease; endstage liver disease; or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin ≥ 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C; see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs; eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization. 20. Active participation in other drug clinical trials or received treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization/enrollment. Exception: Subjects may receive COVID-specific antiviral drugs (eg, remdesivir, hydroxychloroquine). 21. Subjects at randomization who require inhaled corticosteroids or maintenance doses of more than 7.5 mg of prednisone or equivalent per day. 22. Requires or is receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of acalabrutinib. 23. History of hypersensitivity (ie, allergic response) to active or inactive excipients of acalabrutinib or other Btk inhibitors. 24. Known cytoreductive chemotherapy treatment within 14 days of randomization. 25. Major surgery (as defined by the Investigator) within 4 weeks prior to randomization or still recovering from prior surgery. 
Worldwide enrolment start date 13/05/2020 
Enrolment start date in Peru (Initial) 05/07/2020  Enrolment start date in Peru 17/07/2020 
Peru enrolment status Without starting enrollment
Enrollment stopped
  In enrollment
  Enrollment closed 
Clinical Trial Total Duration 12  months Medical Speciality INTERNAL MEDICINE 
Studied Condition (CIE-10 code) -B972 Coronavirus as the cause of diseases classified to other chapters  
Number of subjects to be included in all the countries 140 
Number of subjects to be included in Peru (initial) Number of subjects to be included in Peru (posterior)
30 30
Countries where the enrolment is conducted :
- India - Japan - Turkey
- Germany - Spain - Italy
- Russian Federation - Sweden - South Africa
- Argentina - Brazil - Chile
- Mexico - Peru
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 10  day(s) Subjects' follow up time 90  day(s)
Primary Outcome  
Name of the outcome Metric or method of measurement Time point for the outcome
Proportion of subjects alive and free of respiratory failure at Day 14 Investigator assessment based on Respiratory insuffiency in hospitalized patients due to COVID-19 Infection From randomization to day 14. 
Secondary Outcome
Name of the outcome Metric or method of measurement Time point for the outcome
Proportion of subjects alive and free of respiratory failure at Day 28 Investigational assessment of values of C-reactive protein, ferritin and absolute lymphocyte counts From baseline to Day 28 
Lenght of stay in the Intensive Care Unit Oversight of evolution by the Investigator From Randomization to Day 90 
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 - COMITÉ NACIONAL TRANSITORIO DE ÉTICA EN INVESTIGACIÓN PARA LA EVALUACIÓN Y SUPERVISIÓN DE ÉTICA DE LOS ENSAYOS CLÍNICOS DE LA ENFERMEDAD COVID-19Approved 04/06/2020 04/06/2021127126450  
Co-Investigator
- Hernando Torres Zevallos
- José Luis Cabrera Rivero
- Eneyda Giuvanela Llerena Zegarra
- Karla Ysabel Sanchez Vallejos
- Teresa Jhovina Perez Rodriguez
 
HOSPITAL NACIONAL DOS DE MAYO RCI-77 UNIDAD DE INVESTIGACIÓN CLÍNICA - SERVICIO DE ENFERMEDADES INFECCIOSAS Y TROPICALES
EDUARDO ROMULO TICONA CHAVEZ


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 - COMITÉ NACIONAL TRANSITORIO DE ÉTICA EN INVESTIGACIÓN PARA LA EVALUACIÓN Y SUPERVISIÓN DE ÉTICA DE LOS ENSAYOS CLÍNICOS DE LA ENFERMEDAD COVID-19 Approved 04/07/2020  04/07/2021    - Research Site Extension R.D. 237-2020-OGITT-INS with date 17/07/2020  
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 - COMITÉ NACIONAL TRANSITORIO DE ÉTICA EN INVESTIGACIÓN PARA LA EVALUACIÓN Y SUPERVISIÓN DE ÉTICA DE LOS ENSAYOS CLÍNICOS DE LA ENFERMEDAD COVID-19 Approved 04/07/2020  04/07/2021    - Research Site Extension R.D. 237-2020-OGITT-INS with date 17/07/2020  
Co-Investigator
 
HOSPITAL NACIONAL EDGARDO REBAGLIATI MARTINS RCI-341 UNIDAD DE INVESTIGACIÓN DE CUIDADOS INTENSIVOS
MARTIN OYANGUREN MIRANDA


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 - COMITÉ NACIONAL TRANSITORIO DE ÉTICA EN INVESTIGACIÓN PARA LA EVALUACIÓN Y SUPERVISIÓN DE ÉTICA DE LOS ENSAYOS CLÍNICOS DE LA ENFERMEDAD COVID-19 Approved 04/07/2020  04/07/2021    - Research Site Extension R.D. 270-2020-OGITT-INS with date 04/08/2020  
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 www.astrazenecapersonaldataretention.com
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
Dra Ursula Rodriguez-Frías Rodriguez-Frías Chávez ursula.rodriguezfrias@astrazeneca.com 6101540 Yes Yes Yes
Lic. Kelly Vásquez Rivas-Plata kelly.vasquez@astrazeneca.com 6101515 Yes Yes Yes
Dra. MariadelCarmen Moya Tapia mariadelcarmen.moya@astrazeneca.com 987714838 - 6101557 Yes Yes Yes
AUTHORIZATION STATUS
AUTHORIZED    ACTIVE
TYPE AND NUMBER OF AUTHORIZATION   DOCUMENT R.D.  204-2020-OGITT-INS AUTHRORIZATION   DOCUMENT DATE (dd/mm/aaaa): 30/06/2020  (Validity date from:30/06/2020)
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

 

Clinical Trial Amendment Report
 637-2020-OGITT-INS
13/07/2020

Research Site Extension
R.D. 237-2020-OGITT-INS
17/07/2020

Research Site Extension
R.D. 270-2020-OGITT-INS
04/08/2020

Extension / Modification of Supply List
R.D. 277-2020-OGITT/INS
07/08/2020

Clinical Trial Progress Report
R.D. 
16/09/2020 08:45:03 a.m.

Clinical Trial Progress Report
R.D. 
16/09/2020 08:50:19 a.m.

Clinical Trial Progress Report
R.D. 
16/09/2020 09:02:49 a.m.

Clinical Trial Progress Report
R.D. 
16/09/2020 09:05:23 a.m.