Spanish Version
DATA SHEET
CLINICAL TRIAL REGISTRATION (EC)
EC INS No:  PER-059-20
1. ORGANIZATION / APPLICANTE INSTITUTION
Name of Organization / Institution: IQVIA RDS Perú S.R.L   Type of Organization / Institution : Empresa / Compañia 
Legal Domicile : AV. REPUBLICA DE PANAMA Nro. 3533, Int. 1404, Limatambo, San Isidro 
District: SAN ISIDRO, LIMA 27  Province: LIMA  
Departament: LIMA  
Single Taxpayer No : 20507022601 
Telephone: 01-2649235, 999484309   Fax: 01-6153225 
2. CLINICAL TRIAL GENERAL INFORMATION
Scientific title:
A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY IN ADULTS TO DETERMINE THE SAFETY, EFFICACY, AND IMMUNOGENICITY OF AZD1222, A NON-REPLICATING CHADOX1 VECTOR VACCINE, FOR THE PREVENTION OF COVID-19

Change of Title for Clinical Trial Amendment Request :R.D. 449-2020-OGITT-INS Date 22/10/2020.
Public Title
A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY IN ADULTS TO DETERMINE THE SAFETY, EFFICACY, AND IMMUNOGENICITY OF AZD1222, A NON-REPLICATING CHADOX1 VECTOR VACCINE, FOR THE PREVENTION OF COVID-19

Change of Title for Clinical Trial Amendment Request :R.D. 449-2020-OGITT-INS Date 22/10/2020.
Clinical Trial Registration Date Most recent Clinical Trial Update
17/09/2020  
Principal Sponsor :
1.- ASTRAZENECA AB  
Secondary Sponsor :
 
Funding Source
1.-  ASTRAZENECA AB
Executing Company / Institution / Other
- IQVIA RDS PERÚ S.R.L Authorized with   391-2020-OGITT-INS Date 17/09/2020
Responsabilities
 
  Others
IQVIA RDS Perú S.R.L  
  Inform to the OGITT of the NIH when the first subject is enrolled in Peru, and the end date of enrollment in the country.
  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 D8110C00001 
Secondary ID(s) :  
WHO UTN: NA
CLINICALTRIALS.GOV: NCT04516746
EUDRACT N°:NA
Study Design
D8110C00001 is a Phase III randomized, double-blind, placebo-controlled multicenter study assessing the safety, efficacy, and immunogenicity of AZD1222 compared to saline placebo for the prevention of COVID-19. Participants will be adults ≥ 18 years of age who are healthy or have medically-stable chronic diseases, and are at increased risk for SARS-CoV-2 acquisition and COVID-19. Approximately 30 000 participants will be randomized in a 2:1 ratio to receive 2 IM doses of either 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) AZD1222 (n = approximately 20 000) or saline placebo (n = approximately 10 000) 4 weeks apart, on Days 1 and 29. Randomization will be stratified by age (≥ 18 and < 65 years, and ≥ 65 years), with at least 25% of participants to be enrolled in the older age stratum. Participants who present with at least one of the qualifying symptoms listed below through Day 360 will be assessed for COVID-19. With the exception of fever, shortness of breath, or difficulty breathing, the symptom must be present for 2 or more days. Participants with a COVID-19 qualifying symptom(s) will be tested for SARS-CoV-2, and if positive will complete illness visit assessments, as presented in Table 4. See Section 8.1 for details on COVID-19 assessments. 
Insurance policy due date 31/08/2022  Assignation method Randomized 
Non randomized 
Type of blinding Assignation
Simple  Double  Triple 
Open
Single arm        Parallel
Crossed                 Factorial
Others:
Purpose
-To estimate the efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19 in adults ≥ 18 years of age. -To assess the safety and tolerability of 2 IM doses of AZD1222 compared to placebo in adults ≥ 18 years of age. -To assess the reactogenicity of 2 IM doses of AZD1222 compared to placebo in adults ≥ 18 years of age(Substudy only) 
Research Product Information
Name of the product Generic Name Type of product ATC
AZD1222 ≥ 0.7 X 10 11 PV/ML 5 ML VIAL IM AZD1222 ≥ 0.7 x 10 11 pv/ml 5 mL Vial multidosis Solución para inyección Uso IM      V03
Name of the compare Generic Name Type of product ATC
PLACEBO PARA AZD1222 Placebo para AZD1222      V03
Intervention(s) description:
Group name Type of group N° of participants Intervention(s) description
GROUP 1: AZD1222 ≥ 0.7 X 10 11 PV/ML 5 ML VIAL IM Experimental
Control
2500   Participants will receive 2 doses of either AZD1222 (≥ 0,7 × 1011 pv/ml)); the first dose will be administered on Day 1 and the second dose on Day 29. It is recommended that the study interventions be administered as an IM injection into the deltoid of the non-dominant arm. Other injection sites may be used if necessary. All study participants will be observed in the clinic for at least 15 minutes after vaccination. Each vial of AZD1222 has a label-claim volume of 5mL and can provide up to ten 0.5mL doses. Each dose is prepared by withdrawing 0.5mL from a vial of AZD1222 in a sterile 1 mL or equivalent syringe.
GROUP 2: PLACEBO FOR AZD1222 Experimental
Control
2500   Participants will receive 2 doses of placebo (0.5ml); the first dose will be administered on Day 1 and the second dose on Day 29. It is recommended that the study interventions be administered as an IM injection into the deltoid of the non-dominant arm. Other injection sites may be used if necessary. All study participants will be observed in the clinic for at least 15 minutes after vaccination
Inclusion Criteria
Age 1 Adult, ≥ 18 years of age at the time of consent Type of Participant 2 Increased risk of SARS-CoV-2 infection  Defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19, based on available risk assessment contemporaneous to enrollment (believed to be at risk/exposure) 3 Medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol-specified follow-upA stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrollmentAble to understand and comply with study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative) based on the assessment of the investigator Reproduction 5 Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies 6 Female participants (a) Women of childbearing potential must:  Have a negative pregnancy test on the day of screening and on Day 1  Use one highly effective form of birth control for at least 28 days prior to Day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study intervention. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly (see Table 6). Periodic abstinence, the rhythm method, and withdrawal are NOT acceptable methods of contraception. (b) Women are considered of childbearing potential unless they meet either of the following criteria:  Surgically sterilized (including bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or  Post-menopausal  For women aged < 50 years, post-menopausal is defined as having both: o A history of ≥ 12 months amenorrhea prior to randomization, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and A follicle-stimulating hormone level in the post-menopausal range Until follicle-stimulating hormone is documented to be within menopausal range, the participant is to be considered of childbearing potential  For women aged ≥ 50 years, post-menopausal is defined as having a history of ≥ 12 months amenorrhea prior to randomization, without an alternative cause, following cessation of exogenous sex-hormonal treatment Informed Consent 7 Capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol  
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply: Medical Conditions 1 History of allergy to any component of the vaccine 2 History of Guillain-Barré syndrome 3 Significant infection or other acute illness, including fever > 100 ℉ (> 37.8 °C) on the day prior to or day of randomization 4 History of laboratory-confirmed SARS-CoV-2 infection 5 Any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia 6 Recurrent severe infections and use of immunosuppressant medication within the past 6 months (≥ 20 mg/kg/day of prednisone or its equivalent, given daily or on alternate days for ≥ 15 days within 30 days prior to administration of study intervention) The following exceptions are permitted:  Topical/inhaled steroids or short-term oral steroids (course lasting ≤ 14 days)  Human immunodeficiency virus-positive stable participants on stable antiretroviral therapy (Waldrop et al, 2016) 7 History of primary malignancy except for: (a) Malignancy with low potential risk for recurrence after curative treatment (for example, history of childhood leukaemia) or metastasis (for example, indolent prostate cancer) in the opinion of the site investigator. (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (c) Adequately treated uterine cervical carcinoma in situ without evidence of disease (d) Localized prostate cancer 8 Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture 9 Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness, as judged by the Investigator (mild/moderate well-controlled comorbidities are allowed) 10 Any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data Prior/Concomitant Therapy 11 Receipt of, or planned receipt of investigational products indicated for the treatment or prevention of SARS-CoV-2 or COVID-19 Note: For participants who become hospitalized with COVID-19, receipt of licensed treatment options and/or participation in investigational treatment studies is permitted 12 Receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines within 30 days prior to and after administration of study intervention 13 Receipt of immunoglobulins and/or any blood products within 3 months prior to administration of study intervention or expected receipt during the period of study follow-up Other Exclusions 14 Involvement in the planning and/or conduct of this study (applies to both Sponsor staff and/or staff at the study site) 15 For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding 16 Has donated ≥ 450 mL of blood products within 30 days prior to randomization or expects to donate blood within 90 days of administration of second dose of study intervention 
Worldwide enrolment start date 14/11/2020 
Enrolment start date in Peru (Initial) 03/11/2020  Enrolment start date in Peru 14/11/2020 
Peru enrolment status Without starting enrollment
Enrollment stopped
  In enrollment
  Enrollment closed 
Clinical Trial Total Duration 24  months Medical Speciality INFECTOLOGY 
Studied Condition (CIE-10 code) -J98  
Number of subjects to be included in all the countries 30000 
Number of subjects to be included in Peru (initial) Number of subjects to be included in Peru (posterior)
5000 5000
Countries where the enrolment is conducted :
- Chile - 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 30  day(s) Subjects' follow up time 23  month(s)
Primary Outcome  
Name of the outcome Metric or method of measurement Time point for the outcome
A binary response, whereby a participant is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs≥ 15 days post second dose of study intervention. Otherwise, a participant is not defined as a COVID-19 case. RT-PCR-confirmed SARS-CoV-2 1año 
a)Incidence of adverse events. b)Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest. EA reports 28 days post each dose of study Intervention. / b: from Day 1 post-treatment through Day 730 
Incidence of local and systemic solicited adverse events. Solicited AE e-Diary 7 days post each dose of study intervention 
Secondary Outcome
Name of the outcome Metric or method of measurement Time point for the outcome
Proportion of participants positive for SARS-CoV-2 Nucleocapsid antibodies over time. Serum sample for SARS-CoV-2 nAbs assessment 1 year 
The incidence of the first case of SARS-CoV-2 RT-PCR positive symptomatic illness occurring ≥ 15 days post second dose of study intervention using CDC criteria RT-PCR positive 1 year 
The incidence of the first case of SARS-CoV-2 RT-PCR positive symptomatic illness occurring ≥ 15 days post second dose of study intervention using University of Oxford defined symptom criteria. RT-PCR positive 1 year 
The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring ≥ 15 days post second dose of study intervention. RT-PCR-positive 1 year  
a)Post-treatment GMTs and GMFRs in SARS-CoV-2S, RBD antibodies ; b)The proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to the S, RBD antigens of AZD1222 (MSD serology assay) MSD serology assay 28 days post each dose 
a)Post-treatment GMTs and GMFRs in SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay); b)Proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to AZD1222 as measured by SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay) assay or pseudo-neutralization assay 28 days post each dose  
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
POLICLÍNICO ESPECIALIZADO EN NEUROLOGÍA S.A.C. RCI 1038 Centro de Investigaciones Médicas
SERGIO ELI RECUENCO CABRERA

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 31/08/2020 31/08/202007126450  
Co-Investigator
- Cesar Augusto Gamarra Ayarza
 
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-19 Approved 10/09/2020  10/09/2021    - Research Site Extension R.D. 471-2020-OGITT-INS with date 03/11/2020  
Co-Investigator
 
CLÍNICA RICARDO PALMA RCI-759 CENTRO DE INVESTIGACIÓN RICARDO PALMA
JUAN VICENTE GUANIRA CARRANZA


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 10/09/2020  10/09/2021    - Research Site Extension R.D. 471-2020-OGITT-INS with date 03/11/2020  
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.iqvia.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
Paul Toralva Caceres Paul.Toralva@Quintiles.com 51999484207 Yes Yes Yes
AUTHORIZATION STATUS
AUTHORIZED    ACTIVE
TYPE AND NUMBER OF AUTHORIZATION   DOCUMENT R.D.  391-2020-OGITT-INS AUTHRORIZATION   DOCUMENT DATE (dd/mm/aaaa): 17/09/2020  (Validity date from:17/09/2020)
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
 1217-2020-OGITT/INS
15/10/2020

Clinical Trial Amendment Request
R.D. 449-2020-OGITT-INS
22/10/2020
22/10/2020

Research Site Extension
R.D. 471-2020-OGITT-INS
03/11/2020

Clinical Trial Amendment Report
 1371-2020-OGITT/INS
06/11/2020

Extension / Modification of Supply List
R.D. 505-2020-OGITT-INS
23/11/2020