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DATA SHEET
CLINICAL TRIAL REGISTRATION (EC)
EC INS No:  PER-031-20
1. ORGANIZATION / APPLICANTE INSTITUTION
Name of Organization / Institution: ONCOSALUD S.A.C.  Type of Organization / Institution : Empresa / Compañia 
Legal Domicile : AVENIDA GUARDIA CIVIL 571 SAN BORJA 
District:   Province:  
Departament:  
Single Taxpayer No : 20101039910 
Telephone: 2053500   Fax: 4760959 
2. CLINICAL TRIAL GENERAL INFORMATION
Scientific title:
PHASE 2 STUDY OF EFFICACY AND SAFETY OF PLASMA FROM CONVALESCENT PATIENTS WITH COVID-19 IN PATIENTS WITH MODERATE DISEASE (AUNA 20-01)


Public Title
PHASE 2 STUDY OF EFFICACY AND SAFETY OF PLASMA FROM CONVALESCENT PATIENTS WITH COVID-19 IN PATIENTS WITH MODERATE DISEASE (AUNA 20-01)


Clinical Trial Registration Date Most recent Clinical Trial Update
27/07/2020  
Principal Sponsor :
1.- ONCOSALUD S.A.C.  
Secondary Sponsor :
 
Funding Source
1.-  ONCOSALUD S.A.C.
Executing Company / Institution / Other
- ONCOSALUD S.A.C. Authorized with   263-2020-OGITT-INS Date 27/07/2020
Responsabilities
 
  Others
ONCOSALUD 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
  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 AUNA 20-01 
Secondary ID(s) :  
WHO UTN: NA
CLINICALTRIALS.GOV: NA
EUDRACT N°:NA
Study Design
This is a single arm phase 2 clinical trial to determine the efficacy and safety of convalescent plasma in COVID-19 patients with moderate disease. 
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
To assess the rate of progression from moderate to severe form at 14 days after the first administration of plasma from convalescent patients. 
Research Product Information
Name of the product Generic Name Type of product ATC
PLASMA CONVALECIENTE PLASMA CONVALECIENTE      B05
Intervention(s) description:
Group name Type of group N° of participants Intervention(s) description
Experimental group Experimental
Control
50   They will be given an infusion of a 200 ml unit of convalescent COVID-19 plasma from ABO and compatible RH donors. The procedure will be repeated after 48 hours.
Inclusion Criteria
- Patients of both sexes ≥ 18 years - Patient with a confirmed diagnosis of COVID-19 using moderately classified nasal and pharyngeal swab PCR tests, with some of the following symptoms: Dyspnea or respiratory distress Respiratory rate> 22 breaths / min Arterial oxygen saturation <95% in ambient air Alteration of the level of consciousness Low blood pressure or shock Clinical and / or radiological signs of pneumonia Lymphocyte count less than 1000 cel / uL - Acceptance of participation by signing an informed consent. - That it is not participating in another interventional study for COVID-19. 
Exclusion Criteria
- Patients with a history of previous transfusion allergic reaction. - Pregnant or lactating women (since there are no studies demonstrating their safety in pregnant and / or lactating women). - Patients who have received other types of immunoglobulin therapy in the previous 30 days. - Pediatric patient. 
Worldwide enrolment start date 06/07/2020 
Enrolment start date in Peru (Initial) 06/07/2020  Enrolment start date in Peru  
Peru enrolment status Without starting enrollment
Enrollment stopped
  In enrollment
  Enrollment closed 
Clinical Trial Total Duration 12  months Medical Speciality OTHERS 
Studied Condition (CIE-10 code) -B342 Coronavirus infection, unspecified site  
Number of subjects to be included in all the countries 50 
Number of subjects to be included in Peru (initial) Number of subjects to be included in Peru (posterior)
50 50
Countries where the enrolment is conducted :
- 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 2  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
Moderate phase progression to severe phase Disease progression towards severe COVID 19 (ICU admission) up to 14 days after the first plasma administration. Progression to severe phase will be considered as any person with acute respiratory infection, with two or more of the following criteria: - Respiratory rate> 22 breaths per minute or PaCO2 <32mmHg. - Alteration of the level of consciousness - Systolic blood pressure less than 100 mmHg or MAP <65 mmHg. - PaO2 <60 mmHg or PaFi <300. - Clinical signs of muscle fatigue: nasal flutter, use of accessory muscles, toro-abdominal imbalance. - Serum lactate> 2 mosm / L. Up to 14 days after the first plasma administration. 
Secondary Outcome
Name of the outcome Metric or method of measurement Time point for the outcome
Recovery Defined as the presence of the following criteria: Absence of dyspnea or respiratory distress Respiratory rate from 16 to 22 resp / min Arterial oxygen saturation ≥ 95% Absence of altered level of consciousness Absence of low blood pressure or shock, Absence of clinical and / or radiological signs of pneumonia Lymphocyte count ≥ 1000 cel / u. After the administration of the first dose until discharge or 60 days from the administration of the first dose of the investigational product. 
Dyspnoea Defined as the absence or presence of dyspnea From the first dose to discharge or 60 days from the administration of the first dose of the investigational product. 
Discharge time. Defined as the number of days elapsed from the first dose to discharge. Defined as the number of days elapsed from the first dose to discharge. 
Dependency time of oxygen administration Defined as the number of days elapsed from the first dose to withdrawal of the oxygen supply for clinical improvement. Defined as the number of days elapsed from the first dose to withdrawal of the oxygen supply for clinical improvement. 
Mortality Defined as any death event that occurred from the first dose to day 60 after the first dose of the product under investigation. Defined as any death event that occurred from the first dose to day 60 after the first dose of the product under investigation. 
COVID-19 mortality Defined as a death event due to COVID-19 that occurred between the first day of treatment until day 60. Defined as a death event due to COVID-19 that occurred between the first day of treatment until day 60. 
Post-transfusion adverse events Presence of any adverse event associated with the transfusion From the moment of infusion to 60 days after the first plasma administration 
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
MEDIC SER S.A.C. - AUNA CLÍNICA DELGADO RCI 388 CENTRO DE INVESTIGACIÓN DELGADO
INA NOELIA PÉREZ HUAYNALAYA

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 20/06/2020 20/06/2021127126450  
Co-Investigator
- Alejandro DALY TURCKE
- Alfredo Eric Goytendia Cortez
- Antonio Alfredo Carrasco Yalan
 
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 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
Ina Noelia Pérez Huaynalaya iperez@auna.pe 975369497 Yes Yes Yes
Joseph Arturo Pinto Oblitas jpinto@auna.pe 984322395 Yes
Maria Consuelo Requena Medina mrequena@auna.pe 969899414 Yes
Victor Romario Pizarro Herrera vpizarro@auna.pe 994353992 Yes Yes Yes
AUTHORIZATION STATUS
AUTHORIZED    ACTIVE
TYPE AND NUMBER OF AUTHORIZATION   DOCUMENT R.D.  263-2020-OGITT-INS AUTHRORIZATION   DOCUMENT DATE (dd/mm/aaaa): 27/07/2020  (Validity date from:27/07/2020)
SUMMARY EVALUATION REPORT
APPROVED PROCEDURES
TYPE OF PROCEDURE TYPE AND NUMBER OF RESOLUTION / OFFICIAL LETTER DATE OF RESOLUTION / OFFICIAL LETTER VALIDITY DATE ANNULATION
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TO

 

Clinical Trial Progress Report
 
27/10/2020 04:57:58 p.m.