A Study to Compare the Efficacy and Safety of Different Doses of Ivermectin for COVID-19

NCT04431466 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-10-12

No results posted yet for this study

Summary

In December 2019, a group of patients with pneumonia of unknown cause was linked to a wholesale seafood market in Wuhan, China. The genetic analysis of samples from the lower respiratory tract of these patients indicated a new coronavirus as the causative agent, which was named SARS-CoV-2. The virus spread rapidly to more than 45 countries, including Brazil, causing an international alarm. However, in spite of its epidemiological magnitude, so far, there is no antiviral treatment or vaccine approved for the treatment of this infection. With about 15% to 20% of SARS-CoV-2 patients suffering from serious illnesses and overburdened hospitals, therapeutic options are desperately needed. So, instead of creating compounds from scratch that can take years to develop and test, researchers and public health agencies have sought to redirect drugs already approved for other diseases and known to be widely safe. In this context, the analysis of the international literature shows the existence of an in vitro antiviral activity of ivermectin against SARS-CoV-2. However, there are no studies that have evaluated its clinical effectiveness in patients diagnosed with SARS-CoV-2 infection. Therefore, and considering this knowledge gap, the present study aims to determine the clinical efficacy and safety of different doses of ivermectin in patients diagnosed with SARS-CoV-2 infection.

Conditions

  • Coronavirus Infection

Interventions

DRUG

Ivermectin

SOC plus different dosing regimens of Ivermectin

OTHER

Standard of Care

Standard treatment for COVID-19

Sponsors & Collaborators

  • Universidade Federal de Sao Carlos

    lead OTHER

Principal Investigators

  • Henrique Pott Junior, MD PhD · Universidade Federal de Sao Carlos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04431466 on ClinicalTrials.gov