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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
SOC plus different dosing regimens of Ivermectin
Standard treatment for COVID-19
Hospital Univeristário da Universidade Federal de São Carlos (HU-UFSCar)
São Carlos, São Paulo, Brazil
Hospital Universitário da Universidade Federal de São Carlos (HU-UFSCar)
São Carlos, São Paulo, Brazil
Undetectable viral load during 7 days of follow-up.
Proportion of patients who achieved undetectable viral load during 7 days of follow-up.
Time frame: 7 days following intervention
Viral load variation in the nasopharyngeal swab.
Viral load variation in the nasopharyngeal swab during treatment.
Time frame: 7 days following intervention.
Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab.
Variation of serum lymphocyte counts during treatment.
Time frame: 7 days following intervention.
Incidence of Treatment-Emergent Self-reported Adverse Events
Incidence of Treatment-Emergent Adverse Events as assessed by clinical history and physical examination
Time frame: 28 days following intervention.
Incidence of Treatment-Emergent Laboratory-based Adverse Events
Incidence of Treatment-Emergent Adverse Events as assessed by laboratory tests
Time frame: 28 days following intervention.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.