DATA SHEET
CLINICAL TRIAL REGISTRATION (EC)
EC INS No:  PER-034-20
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:
RANDOMIZED PHASE IIA CLINICAL TRIAL TO COMPARE THE EFFICACY OF IVERMECTIN VERSUS PLACEBO TO OBTAIN NEGATIVE PCR RESULTS IN PATIENTS WITH EARLY PHASE COVID-19


Public Title
RANDOMIZED PHASE IIA CLINICAL TRIAL TO COMPARE THE EFFICACY OF IVERMECTIN VERSUS PLACEBO TO OBTAIN NEGATIVE PCR RESULTS IN PATIENTS WITH EARLY PHASE COVID-19


Clinical Trial Registration Date Most recent Clinical Trial Update
17/07/2020  
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   238-2020-OGITT-INS Date 17/07/2020
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 SAINT-PERÚ 
Secondary ID(s) :  
WHO UTN: NA
CLINICALTRIALS.GOV: NA
EUDRACT N°:NA
Study Design
This al is a triple-blind, randomized phase 2a ontrolled trial with two parallel groups to evaluate the efficacy of ivermectin in reducing nasal viral carriage at 7 days after treatment in SARS-CoV-2 infected patients. The study will recruit 68 patients (34 per group). Selected patients will be randomized to receive one (1) daily dose of 300 mcg/kg ivermectin or an equivalent placebo during three (3) consecutive days, and they will remain in the trial for a period of 21 days.. This study will take place in the Hospital Cayetano Heredia. 
Insurance policy due date 09/04/2021  Assignation method Randomized 
Non randomized 
Type of blinding Assignation
Simple  Double  Triple 
Open
Single arm        Parallel
Crossed                 Factorial
Others:
Purpose
To determine the efficacy of one (1) daily dose of ivermectin during three (3) consecutive days, administered to non-severe COVID-19 patients in the first 96 hours after symptoms onset to reduce the proportion of patients with detectable SARS-CoV-2 RNA by PCR from nasopharyngeal swab at day seven post-treatment. The efficacy of the drug-based strategy to reduce or block transmission involves treating during early phases of infection, when viral replication is yet limited. 
Research Product Information
Name of the product Generic Name Type of product ATC
IVERMECTINA Ivermectina       P03
Intervention(s) description:
Group name Type of group N° of participants Intervention(s) description
IVERMECTIN Experimental
Control
34   The participants will receive one (1) daily dose of 300 mcg/kg ivermectina for three (3) consecutive days. The Ivermectin presentation will be an oral drop solution.
Ivermectin placebo Experimental
Control
34   The participants will receive one (1) daily dose of an ivermectin placebo for three (3) consecutive days. The placebo presentation will be an oral drop solution undistinguishable
Inclusion Criteria
1. Patients with COVID-19 typical symptoms (cough, fever, anosmia) present for not more than 96 hours, 2. The patient must be elder than 18 years old. 3. Not previous administration of ivermectin before the study. 4. No known history of ivermectin allergy. 5. The patient can give his consent to take part in the study. 6. Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin. 
Exclusion Criteria
1. COVID-19 pneumonia • Diagnosed by the attending physician (oxygen saturation < 95% or lung crackles) 2. Positive pregnancy test for women of child bearing age 3. Positive IgG against SARS-CoV-2 by rapid diagnostic test. 4. Negative SARS-CoV-2 PCR from a nasopharyngeal swab.  
Worldwide enrolment start date  
Enrolment start date in Peru (Initial) 09/07/2020  Enrolment start date in Peru 29/08/2020 
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 68 
Number of subjects to be included in Peru (initial) Number of subjects to be included in Peru (posterior)
68 68
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 3  day(s) Subjects' follow up time 21  day(s)
Primary Outcome  
Name of the outcome Metric or method of measurement Time point for the outcome
Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment Use of PCR for SARS-CoV-2. The primary outcome measure will be assessed using Fisher´s exact test. At day 7 post-treatment.  
Secondary Outcome
Name of the outcome Metric or method of measurement Time point for the outcome
Instestinal parasites by means of cuatitative kato-kats and Baerman. The study will use the burden and proportion of intestinal parasites. At day 1 and 14 
Viral load as determined by PCR cycle threshold (Ct). The mean viral load as determined by PCR clycle threshold (Ct) will be used. At baseline and on days 4, 7, 14, and 21  
Patients with fever and cough The proportion of patients with fever an cough will be used. At days 4, 7, 14 and 21 post-treatment 
Patients with seroconversion The proportion of patients with seroconversion will be used At day 21 
Drug-related adverse events The study will use the proportion of drugrelated adverse events. During the entire study  
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 CAYETANO HEREDIA RCI 531 Investigación en Medicina Respiratoria
PATRICIA JANNET GARCÍA FUNEGRA

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 09/07/2020 09/07/2021127126450 - Clinical Trial Research Site Closure Resolución Directoral 281-2020-OGITT-INS with date 10/08/2020
Co-Investigator
- German Javier Malaga Rodrìguez
- Patricia Hilda León Paredes
- César Ugarte Gil
- César Cárcamo Cavagnaro
- Hansel Kevin Mundaca Hurtado
- Carlos Chaccour Díaz
 
HOSPITAL NACIONAL CAYETANO HEREDIA RCI-1188 SERVICIO DE MEDICINA INTERNA
PATRICIA JANNET GARCÍA FUNEGRA


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 09/07/2020  09/07/2021    - Research Site Extension R.D. 339-2020-OGITT-INS with date 27/08/2020

- Clinical Trial Research Site Closure Resolución Directoral134-2021-OGITT-INS with date01/03/2021  
Co-Investigator
 
HOSPITAL NACIONAL DANIEL ALCIDES CARRIÓN RCI-82 UNIDAD DE INVESTIGACIÓN HOSPITAL NACIONAL DANIEL ALCIDES CARRIÓN
JESUS CHACALTANA HUARCAYA


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 26/11/2020  09/07/2020    - Research Site Extension R.D. 529-2020-OGITT/INS with date 03/12/2020  
Co-Investigator
 
COMPLETION DATE: 28/04/2021
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 Jannet García Funegra patricia.garcia@upch.pe 991886872 Yes Yes
Germán Málaga Rodríguez gmalaga01@gmail.com 992768300 Yes Yes
Hansel Kevin Mundaca Hurtado hansel.mundaca@upch.pe 950480633 Yes Yes Yes
AUTHORIZATION STATUS
AUTHORIZED    ACTIVE
TYPE AND NUMBER OF AUTHORIZATION   DOCUMENT R.D.  238-2020-OGITT-INS AUTHRORIZATION   DOCUMENT DATE (dd/mm/aaaa): 17/07/2020  (Validity date from:17/07/2020)
SUMMARY EVALUATION REPORT
APPROVED PROCEDURES
TYPE OF PROCEDURE TYPE AND NUMBER OF RESOLUTION / OFFICIAL LETTER DATE OF RESOLUTION / OFFICIAL LETTER VALIDITY DATE ANNULATION
FROM

TO

 

Clinical Trial Research Site Closure
R.D. 281-2020-OGITT-INS
10/08/2020

Research Site Extension
R.D. 339-2020-OGITT-INS
27/08/2020

Extension / Modification of Supply List
R.D. 485-2020-OGITT/INS
11/11/2020

Research Site Extension
R.D. 529-2020-OGITT/INS
03/12/2020

Clinical Trial Term Extension
R.D. 062-2021-OGITT-INS
28/01/2021
18/01/2021
18/07/2021

Clinical Trial Progress Report
R.D. 
05/02/2021 06:10:21 p.m.

Clinical Trial Progress Report
R.D. 
05/02/2021 06:10:40 p.m.

Clinical Trial Progress Report
R.D. 
05/02/2021 06:10:59 p.m.

Clinical Trial Amendment Report
 287-2021-OGITT-INS
11/02/2021

Research Center Final Report
 
24/02/2021 11:44:26 a.m.

Clinical Trial Research Site Closure
R.D. 134-2021-OGITT-INS
01/03/2021

Clinical Trial Progress Report
R.D. 
28/04/2021 06:09:06 p.m.

Research Center Final Report
R.D. 
05/05/2021 06:51:46 a.m.

Clinical Trial National Final Report
R.D. 
05/05/2021 06:52:09 a.m.