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 - CNTEI
Approved
09/07/2020
09/07/2021
12
7126450
- 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
