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 - CNTEI
Approved
07/07/2020
07/07/2021
12
7126450
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
