Ivermectin Reproposing for Mild Stage COVID-19 Outpatients (IVER-Leve)

April 22, 2021 updated by: Maria de los Angeles Peral de Bruno, Ministry of Public Health, Argentina

Ivermectin Reproposing for COVID-19 Treatment in Outpatients With Mild Stage

Background:

The emergency of COVID-19, along with the current difficulties in responding to the high demand for vaccines, requests to the scientific community to find alternative treatments based on reuse of drugs as a strategy to prevent the progression of the disease in patients infected with SARS COV 2.

Objetive This study aims to evaluate the use of ivermectin in mild-stage patients to increase outpatient discharge and prevent the progression to moderate or severe stages of the disease.

Added value of this study We found that an intervention with ivermectin has impacted on the PPS in a population of outpatients care, between the 5th and 9th day. Also, the treatment increased the probability to obtain outpatient discharge, even in the presence of comorbidities.

Implications of all available evidence.

Research in Context According to the COVID-19 Treatment Guidelines by the NIH, most trials have several limitations. It needs results from adequately powered and well-designed clinical trials to provide evidence-based guidance on the role of ivermectin in the treatment of COVID- 19. However, our study shows overlaps in benefits with other authors, and taking together, these results are encouraging for further study about repurposing ivermectin for the treatment of COVID-19.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Technical Design:

Cluster Randomised Trials in outpatients care, n = 254. The subjects were divided into experimental (EG: n = 110) and control groups (CG: n = 144). The criteria for this choice were based on the geographical distribution of Health Services, locomotion, and logistics in current times of pandemic.

Sample Size:

Sample size was determined by the test comparing two proportions. It considered the following parameters to the bilateral test: n = 30,000 Total operating area population for services network to Primary Care; 95% confidence level, 3% precision, 5% proportion, n = 201 sample size without loss, 20% expected proportion of losses. The sample size calculated was n= 252 participants.

Participants:

The total group n = 254 enrolled outpatients care from the urban area-department heads and peri-urban area of the City San Miguel de Tucumán. The study was conducted between September 2020 to January 2021. The health coverage service was administered by the Health System of the State of Tucumán (SI.PRO.SA, Tucumán, Argentina). The people who agreed to participate in the study gave their informed consent before starting the study (Research Ethics Committee / Health Research Directorate, file number 054/2020).

Intervention Protocol:

The EG received protocol ivermectin orally 4 tablets of 6 mg = 24 mg every 7 days for 4 weeks plus symptomatic treatment (500mg paracetamol every 6 or 8h, no more than 4 tablets daily;100mg aspirin, 1 tablet per day with breakfast; 150mg Ranitidine, 1 tablet in the morning, and 1 tablet at night). The CG received only symptomatic treatment. Patients with comorbidities continued with the basic medication for the underlying pathology . All participants were evaluated by physical examination and COVID-19 infection was diagnosed with positive RT-PCR. Clinical evaluation of symptoms was carried throughout the study period. Enrolled subjects completed symptom questionnaires (including reporting of any adverse effects of treatment), physical examinations and remote clinical telemedicine follow-up and received outpatient discharge 4 weeks after the start of the intervention.

The 10-category ordinal scale recommended by the WHO was used to classify patients according to clinical patient state: ambulatory mild disease, moderate disease, severe disease.

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • Argentina
      • Tucumán, Argentina, 4000
        • SI.PRO.SA, Ministerio de Salud Pública

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

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Outpatients infected by SARSCoV-2 confirmed either by RT-PCR test, Neo Kit or rapid test authorized by ANMAT or by close contact or epidemiological link;
  • Women of childbearing age with a negative pregnancy test;
  • Mild disease-patients with two or more of the following symptoms: fever less than 38·5°C and higher than 37.5°C according to Ministry of Health, Argentina(16), isolated diarrheal episodes, hyposmia or hypogeusia, mild desaturation (between 96 and 93%), dyspnea, polyarthralgia, persistent headache, abdominal pain, erythema of the kidney, nonspecific rash.

Exclusion Criteria:

  • Hypersensitivity or allergy to Ivermectin;
  • Pregnant or lactating;
  • Children or adolescents under 18 years of age;
  • Patients with Neurological Pathology, Renal Insufficiency, Hepatic Insufficiency;
  • Weight less than 40kg;
  • Patients with concomitant use of drugs that act on GABA, barbiturate and benzodiazepine receptors;
  • Patients who have not completed / signed the informed consent.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental Group

The EG received Ivermectin orally 4 tablets of 6 mg = 24 mg every 7 days for 4 weeks.

All participants were evaluated by physical examination COVID-19 diagnosed with positive RT-PCR at the beginning, and final of the protocol
Drug: Ivermectin
Experimental Group received Ivermectin orally 4 tablets of 6 mg = 24 mg every 7 days for 4 weeks.
Other Names:
  • N/D
NO_INTERVENTION: Control Group
Conventional treatment. All participants were evaluated by physical examination COVID-19 diagnosed with positive RT-PCR at the beginning, and final of the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion test
Time Frame: from 5th to 9th day.
a) Proportion of patients with symptoms (fever, diarrhea, taste and/or smell disturbance, SpO2, polyarthralgia, headache, body pain, abdominal pain, ALRI symptoms and signs)
from 5th to 9th day.
Proportion test
Time Frame: from 10th to 14th day.
Proportion of patientts with symptoms (fever, diarrhea, taste and/or smell disturbance, SpO2, polyarthralgia, headache, body pain, abdominal pain, ALRI symptoms and signs)
from 10th to 14th day.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Odd Ratio
Time Frame: 28 days after enrollment
Medical release: numbers of participants with absence of clinical symptoms relation to COVID-19 disease.
28 days after enrollment
Odd Ratio and logistic regression test
Time Frame: 28 days after enrollment
Relative risk of being cured "with" or "without" treatment
28 days after enrollment

Collaborators and Investigators

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

Sponsor

Ministry of Public Health, Argentina

Investigators

  • Principal Investigator: Rossana E. Chahla, MD. Ph.D., Ministery of Health, Tucumán, Argentina

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

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 (ACTUAL)

September 20, 2020

Primary Completion (ACTUAL)

December 20, 2020

Study Completion (ACTUAL)

January 18, 2021

Study Registration Dates

First Submitted

February 20, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (ACTUAL)

March 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5077-410-CH2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

N/D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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