DATA SHEET
CLINICAL TRIAL REGISTRATION (EC)
EC INS No:  PER-060-20
1. ORGANIZATION / APPLICANTE INSTITUTION
Name of Organization / Institution: Marina de Guerra del Perú  Type of Organization / Institution : Entidad gubernamental del país 
Legal Domicile : AV. LA MARINA CDRA 36 NRO. S/N CUARTEL LA PERLA (AV. LA MARINA CDRA. 36 ESQ. INSURGENTES) 
District: La Perla - Callao  Province: Lima 
Departament: Lima 
Single Taxpayer No : 20153408191 
Telephone: 2078900 Anx 1400 / 1401   Fax:  
2. CLINICAL TRIAL GENERAL INFORMATION
Scientific title:
RANDOMIZED PHASE 2 CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF THE USE OF PLASMA FROM CONVALESCENT PATIENTS WITH THE NEW CORONAVIRUS DISEASE (COVID-19) FOR THE EXPERIMENTAL TREATMENT OF PATIENTS HOSPITALIZED IN THE CENTRO MÉDICO NAVAL "CIRUJANO MAYOR SANTIAGO TÁVARA"


Public Title
RANDOMIZED PHASE 2 CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF THE USE OF PLASMA FROM CONVALESCENT PATIENTS WITH THE NEW CORONAVIRUS DISEASE (COVID-19) FOR THE EXPERIMENTAL TREATMENT OF PATIENTS HOSPITALIZED IN THE CENTRO MÉDICO NAVAL "CIRUJANO MAYOR SANTIAGO TÁVARA" "


Clinical Trial Registration Date Most recent Clinical Trial Update
21/09/2020  
Principal Sponsor :
1.- MARINA DE GUERRA DEL PERÚ  
Secondary Sponsor :
 
Funding Source
1.-  MARINA DE GUERRA DEL PERÚ
Executing Company / Institution / Other
- MARINA DE GUERRA DEL PERÚ Authorized with   399-2020-OGITT-INS Date 21/09/2020
Responsabilities
 
  Others
Marina de Guerra del Perú  
  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 CEMENA-20-01 
Secondary ID(s) :  
WHO UTN: NA
CLINICALTRIALS.GOV: NA
EUDRACT N°:NA
Study Design
Phase 2 clinical trial, randomized 1:1, open label; which is intended to evaluate the safety and efficacy of experimental treatment with COVID-19 convalescent plasma in patients with SARS-CoV-2 infection. Two arms will be available, with the experimental group receiving convalescing plasma plus standard hospital treatment; while the control group will receive standard treatment. This study will be carried out in two phases: Collection phase: The system of donor awareness and recruitment, collection, study and storage of convalescing plasma will be established. It is estimated to collect plasma from 50 patients recovered from COVID-19 centrally. Experimental Treatment Phase: It will start as soon as the first units of Convalescent Plasma are available, the experimental group will receive 1 to 2 units of 200mL of plasma (ABO, Rh compatible), obtained according to the established criteria, for the treatment of patients hospitalized by COVID-19.  
Insurance policy due date 04/02/2021  Assignation method Randomized 
Non randomized 
Type of blinding Assignation
Simple  Double  Triple 
Open
Single arm        Parallel
Crossed                 Factorial
Others:
Purpose
Evaluate experimental treatment with COVID-19 Convalescent Plasma in patients diagnosed with COVID-19 by SARS-CoV2 who are hospitalized at the Naval Medical Center "Surgeon Major Santiago Távara" with moderate or severe disease in the follow-up time of the study.  
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 Experimental
Control
100   A 200 ml unit of COVID 19 convalescent donor s plasma will be transfused considering ABO and Rh compatibility through an intravenous line up to 2 times spaced 24 hours apart.
Inclusion Criteria
• Patients over 18 years of age from both sexes hospitalized at the Centro Médico Naval. • Be in the disposition and capacity to give free and informed consent, or have a relative or tutor with the capacity to do so (Appendix 2) • Be in the disposition and capacity to undergo clinical evaluations and diagnosis procedures. • Previous COVID-19 diagnosis supported by a laboratory test (PCR-RT or by the presence of SARS-CoV-2 antibodies). • Diagnosis of moderate to severe Acute Respiratory Distress Syndrome, according to the definition of the Berlin criteria during a span of less than 10 days. • Need of mechanical ventilation or continuous oxygenation at positive pressure. 
Exclusion Criteria
• Diagnosis of Mild Acute Respiratory Distress Syndrome according to the definition of the Berlin criteria. • Diagnosis of moderate to severe Acute Respiratory Distress Syndrome, according to the definition of the Berlin criteria, lasting more than 10 days. • Demonstrated hypersensitivity or history of allergy to blood products or immunoglobulins. • Pregnant or breastfeeding women  
Worldwide enrolment start date 07/09/2020 
Enrolment start date in Peru (Initial) 07/09/2020  Enrolment start date in Peru 19/10/2020 
Peru enrolment status Without starting enrollment
Enrollment stopped
  In enrollment
  Enrollment closed 
Clinical Trial Total Duration 6  months Medical Speciality OTHERS 
Studied Condition (CIE-10 code) -B342 Coronavirus infection, unspecified site  
Number of subjects to be included in all the countries 100 
Number of subjects to be included in Peru (initial) Number of subjects to be included in Peru (posterior)
100 100
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 60  day(s)
Primary Outcome  
Name of the outcome Metric or method of measurement Time point for the outcome
Mortality It is defined as an event of death due to the 2019 Coronavirus disease or another cause that occurred between the start of treatment until day 60. 60 days from the first day of treatment. 
Secondary Outcome
Name of the outcome Metric or method of measurement Time point for the outcome
Time use of mechanical ventilation Time in days of use of mechanically ventilated breathing support for each study group (Experimental and Control), this measurement will be performed at the end of the study and until the last enlisted participant is monitored for 60 days of follow-up 60 days from the first day of treatment.  
Serious adverse events Percentage of participants who had serious adverse events related to convalescing plasma transfusion for each study group (Experimental and Control), this measure will be performed at the end of the study and up to the completion of the last 60 days of follow-up to the last enlisted participant. 60 days from the first day of treatment.  
Time of use High flow Time Time in days of use of respiratory support with High Flow Cannula for each study group (Experimental and Control), this measurement will be performed at the end of the study and up to the last enlisted participant to complete the 60 days of follow-up. 60 days from the first day of treatment.  
Supplemental Oxygen Dependence Time Time in days of the need for respiratory support with any type of oxygen therapy for each group of the study (Experimental and control), this measure will be performed at the end of the study and until the last enlisted participant is monitored for the last 60 days of follow-up 60 days from the first day of treatment.  
Length of hospital stay. Time in hospitalization days for each study group (Experimental and Control), this measure will be performed at the end of the study and up to the last enlisted participant to complete the 60 days of follow-up. 60 days from the first day of treatment.  
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
CENTRO MEDICO NAVAL "CIRUJANO MAYOR SANTIAGO TAVARA" RCI 3001 UNIDAD DE INVESTIGACIÓN DEL CENTRO MÉDICO NAVAL
MARIO ORTIZ MONDRAGÓN

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 - CNTEIApproved 07/07/2020 07/07/2021127126450  
Co-Investigator
- César José Suárez De Armero
- José Martín Avilés Calderón
- Max Grogl .
 
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
Mario Ortiz Mondragón ortiz60marina51@hotmail.com 997530194 Yes Yes Yes
José Martín Avilés Calderón josacal@gmail.com 999442818 Yes Yes Yes
César José Suárez De Armero pepedearmero@hotmail.com 958066862 Yes Yes Yes
Max Grogl max.grogl@gmail.com 998044257 Yes
AUTHORIZATION STATUS
AUTHORIZED    ACTIVE
TYPE AND NUMBER OF AUTHORIZATION   DOCUMENT R.D.  399-2020-OGITT-INS AUTHRORIZATION   DOCUMENT DATE (dd/mm/aaaa): 21/09/2020  (Validity date from:21/09/2020)
SUMMARY EVALUATION REPORT
APPROVED PROCEDURES
TYPE OF PROCEDURE TYPE AND NUMBER OF RESOLUTION / OFFICIAL LETTER DATE OF RESOLUTION / OFFICIAL LETTER VALIDITY DATE ANNULATION
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