Spanish Version
DATA SHEET
CLINICAL TRIAL REGISTRATION (EC)
EC INS No:  PER-013-20
1. ORGANIZATION / APPLICANTE INSTITUTION
Name of Organization / Institution: SEGURO SOCIAL DE SALUD- ESSALUD  Type of Organization / Institution : Entidad gubernamental del país 
Legal Domicile : Caminos del inca 
District: Jesus María  Province: Lima 
Departament: Lima 
Single Taxpayer No : 20131257750 
Telephone: 952393544   Fax: 2656000 anexo 2718 
2. CLINICAL TRIAL GENERAL INFORMATION
Scientific title:
CONVALESCENT PLASMA USE AS TREATMENT FOR HOSPITALIZED PATIENTS WITH COVID-19 IN ESSALUD


Public Title
CONVALESCENT PLASMA AS TREATMENT FOR COVID-19


Clinical Trial Registration Date Most recent Clinical Trial Update
25/06/2020  
Principal Sponsor :
1.- SEGURO SOCIAL DE SALUD- ESSALUD  
Secondary Sponsor :
 
Funding Source
1.-  SEGURO SOCIAL DE SALUD - ESSALUD
Executing Company / Institution / Other
- SEGURO SOCIAL DE SALUD- ESSALUD Authorized with   198-2020-OGITT-INS Date 25/06/2020
Responsabilities
 
  Others
SEGURO SOCIAL DE SALUD- ESSALUD  
  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: II  Protocol Code ESSALUD-012020 
Secondary ID(s) :  
WHO UTN: NA
CLINICALTRIALS.GOV: NA
EUDRACT N°:NA
Study Design
Clinical trial controled with paralel groups, Phase II fo efecctiviness and safety to use plasma convalescent in hospitalized patient with COVID-19, compared with placebo (1:1) at Hospital Nacional Edgardo Rebagliati Martins 
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 evaluate the efficacy of convalescent plasma from patients recovered from COVID-19 to treat hospitalized patients with confirmed SARS-CoV-19 diagnosis in the Hospital Nacional Edgardo Rebagliati Martins during 2020. 
Research Product Information
Name of the product Generic Name Type of product ATC
PLASMA CONVALECIENTE PLASMA CONVALECIENTE      B05
Name of the compare Generic Name Type of product ATC
PLACEBO Placebo      
Intervention(s) description:
Group name Type of group N° of participants Intervention(s) description
EXPERIMENTAL GROUP Experimental
Control
60   CONVALESCENT PLASMA
CONTROL GROUP Experimental
Control
60   STANDAR CARE
Inclusion Criteria
1. Hospitalized patients ≥18 años 2. Informed consent 3. Confirmed diagnosis of SARS-CoV2 infection via RT-PCR of nasopharingeal swabing 4. Patients at risk of progression defined as having two or more of the following: • Ferritin > 500 ng/mL • D-dimer > 1 mg/L • Reactive C-Protein > 15 mg/L • Total Lymphocytes < 1000/mm3 or Neutrophil/Lymphocyte ratio > 3.13 • Admission to a Intense care unit for management of COVID-19 or pacients with severe diasease defined as having two or more of the following: • Dispnea • Respiratory rate >= 30 per minute • Oxygen Saturation < 93% • Po2/Fio2 < 300 • Lung infiltrates > 50% in chest X-ray or Chest CT scan Iwith increasing compromise in a 24-48 hours period  
Exclusion Criteria
1. Previous trasfusion of any hemoderivate in the 120 days prior to convalescent plasma administration 2. Active gestation  
Worldwide enrolment start date 01/06/2020 
Enrolment start date in Peru (Initial) 01/06/2020  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 INFECTOLOGY 
Studied Condition (CIE-10 code) -B342 Coronavirus infection, unspecified site  
Number of subjects to be included in all the countries 192 
Number of subjects to be included in Peru (initial) Number of subjects to be included in Peru (posterior)
192 192
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 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
Oxygen Requirement Ventilation Requirement Death Adverse Events Clinical evaluation of patient requirements of O2 reservoir mask or high flux O2 or Non-Invasive ventilation with O2 Clinical evaluation of patient requirements of mechanical ventilation or extracorporeal oxygenation (ECMO) Clinical evaluation or report of death status Report of adverse events attributables to convalescent plasma Day 14 and 28 after plasma administration Day 14 and 28 after plasma administration Day 14, 28 and 56 after plasma administration During first 28 days after plasma administration  
Secondary Outcome
Name of the outcome Metric or method of measurement Time point for the outcome
Time to ventilation Time in days from plasma administration until ventilation use During first 28 days after 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
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-19Approved 01/06/2020 01/06/2021127126450  
Co-Investigator
- LEDA YAMILEE HURTADO ROCA
- ROGER VLADIMIR ARAUJO CASTILLO
- AUSBERTO CHUNGA CHUNGA
- IBETH MELANIA NEYRA VERA
- PERCY SOTO BECERRA
- JORGE MAGUIÑA QUISPE
- ARTURO SAGASTEGUI SOTO
- CHIRISTIAN Villanueva GONZALES
 
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 http://www.essalud.gob.pe/ietsi/
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
AUSBERTO CHUNGA CHUNGA Bettochunga17@hotmail.com 990149288 Yes
AUTHORIZATION STATUS
AUTHORIZED    ACTIVE
TYPE AND NUMBER OF AUTHORIZATION   DOCUMENT R.D.  198-2020-OGITT-INS AUTHRORIZATION   DOCUMENT DATE (dd/mm/aaaa): 25/06/2020  (Validity date from:25/06/2020)
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
 813-2020-OGITT-INS
14/08/2020

Clinical Trial Amendment Report
 928-2020-OGITT-INS
04/09/2020