Clinical Trial to "Study the Efficacy and Therapeutic Safety of Ivermectin: (SAINTBO) (SAINTBO)

April 6, 2021 updated by: Jorge Luis Aviles, Universidad Mayor de San Simón

Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Therapeutic Safety of Ivermectin Versus Placebo Associated With Standard of Care Treatment in the Early Phase of Coronavirus Infection (COVID19).

Coronavirus disease (COVID-19) is an infectious disease caused by a new virus. The disease causes a respiratory illness (such as the flu) with symptoms such as cough, fever, and, in more severe cases, respiratory distress, even developing Acute Respiratory Distress Syndrome, evolving in some cases with the death of the patient. Currently, there are no specific treatments for COVID-19. Currently, there are several ongoing clinical trials evaluating possible treatments. Recently, Leon Caly reports here that Ivermectin, an FDA-approved antiparasitic that was shown to have broad-spectrum antiviral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero cells. hours after infection with SARS-CoV-2 capable of a 5000-fold reduction in viral RNA at 48 h. (1) Ivermectin, therefore, warrants further investigation for possible benefits in humans. The reason for this study is to understand the effect of the drug in eradicating the virus.

It is a randomized controlled trial to evaluate the efficacy of Ivermectin in COVID-19. The recruited patient will be assigned to two groups, (1) a group received ivermectin plus care treatment (2) the placebo group plus standard care treatment. The result will be recorded by documenting the RT-PCR reports confirmed at the time of recruitment and at 7 and 14 days within the framework of the study, then they will be adapted to the national care protocol, with 9 scheduled clinical and telemedicine interviews.

It will be a randomized controlled trial to be run in RT-PCR confirmed COVID-19 patients who meet the inclusion criteria (asymptomatic/mild to moderate severity).

They will be divided into groups after randomization. Group A will be administered one (1) a group received ivermectin plus standard of care treatment (2) the placebo group plus standard of care treatment, along with the existing inpatient and outpatient management clinical guidelines of the hospitals participating in the study, these being adapted to the National standard.

The reverse transcriptase-polymerase chain reaction (RT-PCR) will be carried out on days 7 and 14 after the therapeutic intervention and the duration of time at which the RT-PCR becomes negative and/or clinical evolution of the patient will be compared in both study groups. The dose of the drug is not subject to change according to the patient's response or the possible side effect of being administered in a single dose.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

STUDY DESIGN It is a double-blind, randomized, placebo-controlled superiority trial with two parallel arms. Participants will be randomized to receive a single 600 µg / kg dose of ivermectin or placebo, and the number of patients in the treatment and placebo groups will be in a 2: 1 ratio for the intervention group.

The trial statistician will generate the randomization code using blocks of four individuals to ensure the balance between groups. The assignment will be carried out by the main investigator using opaque envelopes, after obtaining informed consent and verification of compliance with all the inclusion and exclusion criteria. The investigational product will be administered by personnel who are not involved in patient care or monitoring of study participants.

Participants will be followed up at their homes for a period of 28 days. A patient can discontinue her participation in the study at any time and for any reason. The principal investigator and the panel of experts that make up the safety and adverse effects committee may also withdraw a patient from the study if they believe it is in the best interest of the patient.

Serious adverse events (SAEs) related to ivermectin will be followed until they resolve or up to 28 days after the participant's final visit, whichever occurs first. All other SAEs deemed unrelated to ivermectin will be followed up until the participant's final visit or for a specified period at the discretion of the principal investigator.

The study will end when the final randomized patient has completed the study, all planned visits have been completed, and inconsistencies in the data have been resolved.

OBJECTIVES Primary objective

• To explore the efficacy and therapeutic safety of Ivermectin in patients with non-severe and low-risk COVID-19 in the first 72 hours after the onset of symptoms, through the negativization of the polymerase chain in real time. RT-PCR (nasopharyngeal swab) and clinical improvement on day 7 and 28 after treatment, to explore its possible use in the fight against the pandemic.

Secondary objectives

  1. To evaluate the efficacy of ivermectin in reducing the SARS-CoV-2 viral load in the nasopharyngeal swab on day 7 after treatment.
  2. To evaluate the efficacy of ivermectin in improving the progression of symptoms in treated patients.
  3. Assess the proportion of seroconversions in patients treated on day 21.
  4. Evaluate the safety of ivermectin at the proposed dose.
  5. Determine the magnitude of the immune response against SARS-CoV-2
  6. Evaluate the early kinetics of immunity against SARS-CoV-2

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bolivia
      • Cochabamba, Bolivia
        • Universidad Mayor de San Simon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed case of COVID-19 in national reference hospitals - COVID sentinel hospitals.
  • Male and female patients 18 to 75 years (inclusive) of age.
  • Supply of signed and dated informed consent form
  • Declared availability to comply with all study procedures and availability for the duration of the study.
  • In good general health with mild or moderate symptoms during the first week of disease evolution (onset of symptoms maximum 7 days before recruitment).
  • Ability to take oral medications and be willing to adhere to the medication consumption regimen prescribed in the study.
  • The patient must, in the opinion of the principal investigator, be able to comply with all the requirements of the clinical trial (including home monitoring during isolation).
  • The patient is able and willing to comply with the requirements of this test protocol. Voluntarily signed informed consent obtained prior to any proceeding related to the trial.

Exclusion Criteria:

  1. Known history of ivermectin allergy
  2. Hypersensitivity to any component of ivermectin or the excipients of the brand to be used.

  3. COVID-19 pneumonia

    • Diagnosed by the treating physician
    • Identified on a chest x-ray
  4. Fever or cough present for more than 48 hours.
  5. immunoglobulin G (IgG) positive against SARS-CoV-2 by a rapid diagnostic test

8. Recent travel history to loa endemic countries (Angola, Cameroon, Central African Republic, Chad, the Democratic Republic of the Congo, Ethiopia, Equatorial Guinea, Gabon, Republic of the Congo, Nigeria, and Sudan) 9. Current use of quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir, or cobicistat. Use of critical drugs such as warfarin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ivermectin
Participants will receive a single 600 µg / kg dose of ivermectin.
Drug: Ivermectin
Participants will be randomly assigned to receive a single 600 µg / kg dose of ivermectin or placebo.
Other Names:
  • A
Placebo Comparator: Placebo Comparator
Participants will receive a single dose of placebo.
Drug: Placebo
Participants will be randomly assigned to receive a single of placebo.
Other Names:
  • B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of viral load
Time Frame: 3 days
A comparison will be made between the initial viral load before the dose of ivermectin with respect to the viral load on the third day after the administration of the drug. The primary outcome of interest will be the correlation between the use of a treatment regimen containing Ivermectin plus the standard of care, with the endpoint of measurement relative to the difference in viral loads.
3 days
Clinical remission
Time Frame: 28 days
Clinical remission, defined as a remission of all the patient's symptoms based on the clinical management protocol. The primary outcome of interest will be the correlation between the use of a treatment regimen containing Ivermectin plus the standard of care, initiated early after the confirmed diagnosis of COVID-19 with the endpoint of measurement relative to the difference in clinical evolution.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical signs of toxicity
Time Frame: 28 days
The secondary outcome of interest will be the correlation between these treatment regimens and the appearance of clinical signs of toxicity or adverse effects (defined as the first clinical or laboratory finding of a neurological, hepatic, renal, hematological, or pancreatic alteration, or verification of alterations in pupillometry during the outpatient clinical course or hospitalization.
28 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for supplemental oxygen
Time Frame: 28 days
The need for supplemental oxygen implementation will be evaluated
28 days
Hospital stay
Time Frame: 3 months
The need for hospital care and the stay both in general wards and in intensive care (ICU) will be evaluated.
3 months
Need for mechanical ventilation
Time Frame: 21 days
The need to implement the intervention through mechanical ventilation will be evaluated.
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Mayor de San Simón

Collaborators

Université Catholique de Louvain
Barcelona Institute for Global Health

Investigators

  • Study Director: Carlos L Erostegui, MPH, Universidad Mayor de San Simon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 8, 2021

Primary Completion (Anticipated)

July 8, 2021

Study Completion (Anticipated)

December 5, 2021

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

It is planned to grant the respective information stored in a repository.

IPD Sharing Time Frame

until August 2021

IPD Sharing Access Criteria

unrestricted access

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Ivermectin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe