Spanish Version
DATA SHEET
CLINICAL TRIAL REGISTRATION (EC)
EC INS No:  PER-016-20
1. ORGANIZATION / APPLICANTE INSTITUTION
Name of Organization / Institution: UNIVERSIDAD PERUANA CAYETANO HEREDIA   Type of Organization / Institution : Universidad 
Legal Domicile : Av. Honorio Delgado 430 
District: San Martin de Porres  Province: Lima 
Departament: Lima 
Single Taxpayer No : 20110768151 
Telephone: 3190000   Fax:  
2. CLINICAL TRIAL GENERAL INFORMATION
Scientific title:
PERUCONPLASMA: RANDOMIZED CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF THE USE OF CONVALESCENT PLASMA IN HOSPITALIZED PATIENTS WITH COVID-19


Public Title
PERUCONPLASMA: EVALUATING THE USE OF CONVALESCENT PLASMA AS MANAGEMENT OF COVID-19


Clinical Trial Registration Date Most recent Clinical Trial Update
27/06/2020  
Principal Sponsor :
1.- UNIVERSIDAD PERUANA CAYETANO HEREDIA  
Secondary Sponsor :
 
Funding Source
1.-  UNIVERSIDAD PERUANA CAYETANO HEREDIA
Executing Company / Institution / Other
- UNIVERSIDAD PERUANA CAYETANO HEREDIA Authorized with   303-2020-OGITT-INS Date 27/06/2020
Responsabilities
 
  Others
UNIVERSIDAD PERUANA CAYETANO HEREDIA  
  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 N/A 
Secondary ID(s) :  
WHO UTN: NA
CLINICALTRIALS.GOV: NA
EUDRACT N°:NA
Study Design
Open-label, randomized (1:1) phase 2b clinical trial to evaluate the safety and efficacy of the use of convalescent plasma. This study will have two arms, one arm will receive convalescent plasma plus standard of care, and the other arm will receive the standard of care only. This study will consist of two phases: Implementation phase: A centralized system will be implemented to recruitment of plasma donors, and for collection, processing and storage of convalescent plasma and plasma aliquots for future studies. We expect to collect plasma from at least 30 recovered COVID-19 patients before starting the next phase of the study. Use of convalescent plasma phase: Patients from the experimental group will receive 1 to 2 units of ABO compatible COVID-19 convalescent plasma (200 ml to 250 ml each), obtained according to the established criteria, in addition to the standard of care. Patients from the control group will receive the standard of care. Safety of convalescent plasma administration will be evaluated, as well as other indicators of clinical efficacy. Adults older than 18 years old, hospitalized with diagnosis of COVID-19 confirmed by a laboratory test, with severe or critical disease, will be included to the study after obtaining inform consent by the patient of a direct family member. 
Insurance policy due date 30/11/2020  Assignation method Randomized 
Non randomized 
Type of blinding Assignation
Simple  Double  Triple 
Open
Single arm        Parallel
Crossed                 Factorial
Others:
Purpose
To evaluate the safety of COVID-19 convalescent plasma administration to hospitalized patients with as management of severe or critical disease, by reporting the proportion of patients with serious adverse events related to the study treatment. 
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
49   1 to 2 units of 200 ml to 250 ml of COVID-19 convalescent from recovered COVID-19 patients
Control group Experimental
Control
49   Local standard of care
Inclusion Criteria
􀀀 18 years old or older 􀀀 Hospitalized patient with COVID-19 disease, confirmed by a molecular test or a serologic test, along with a typical COVID-19 clinical presentation. 􀀀 Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more of the following criteria: • Respiratory frequency >22 • O2 saturation ≤93% • PaO2 <60mmHg, PaCO2 >50mmHg o • PaO2/FiO2 <300 Or Critical disease with one or more o the following criteria: • Respiratory insufficiency with requirement of mechanical ventilation within the last 72hours • Shock 􀀀 Inform consent signed by patient or direct family member 
Exclusion Criteria
􀀀 Contraindication for transfusion (history of TRALI or TACO, history of anaphylaxis to blood components 􀀀 Multiorgan failure, defined by a SOFA score of >5 􀀀 Hemodinamically unstable, with PA<60 mmH, refractory to the use of vasopressors 􀀀 Uncontroled concomitant infection 􀀀 Disseminated intravascular coagulation 􀀀 Miocardial infarction 􀀀 Acute coronary disease 􀀀 Patient on dialysis 􀀀 Intracranieal bleeding active within last 7 days. 
Worldwide enrolment start date  
Enrolment start date in Peru (Initial) 01/06/2020  Enrolment start date in Peru 21/09/2020 
Peru enrolment status Without starting enrollment
Enrollment stopped
  In enrollment
  Enrollment closed 
Clinical Trial Total Duration 6  months Medical Speciality INFECTOLOGY 
Studied Condition (CIE-10 code) -B342 Coronavirus infection, unspecified site  
Number of subjects to be included in all the countries 98 
Number of subjects to be included in Peru (initial) Number of subjects to be included in Peru (posterior)
98 98
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 30  day(s)
Primary Outcome  
Name of the outcome Metric or method of measurement Time point for the outcome
Serious adverse events related to transfusion of convalescent plasma rate of development of serious adverse events 6 months 
Secondary Outcome
Name of the outcome Metric or method of measurement Time point for the outcome
all-cause mortality determination of 30-day mortality rate 6 months 
Hospital length stay Calculation of the median of hospital stay 6 months 
Length of ICU stay Median length of ICU stay 6 months 
Length of mechanical ventilation Median time of mechanical ventilation required from the day of enrollment 6 months 
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 HIPÓLITO UNANUE RCI 542 Hospital Nacional Hipólito Unanue
ALONSO RICARDO SOTO TARAZONA

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
 
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
Patricia García Funegra patricia.garcia@upch.pe 991886872 Yes Yes Yes
Fiorella Krapp López fiorella.krapp@upch.pe 922221127 Yes Yes Yes
Alonso Soto Tarazona sotosolari@yahoo.com 996128953 Yes Yes
Martin Montes Delgado martin.montes@upch.pe 949342278 Yes
Enrique Argumanis Sánchez eargumanis@hotmail.com 999662448 Yes
AUTHORIZATION STATUS
AUTHORIZED    ACTIVE
TYPE AND NUMBER OF AUTHORIZATION   DOCUMENT R.D.  303-2020-OGITT-INS AUTHRORIZATION   DOCUMENT DATE (dd/mm/aaaa): 27/06/2020  (Validity date from:27/06/2020)
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
 918-2020-OGITT-INS
04/09/2020