A Phase 2 interventional study of Ivermectin and Standard of Care in Coronavirus Infection, sponsored by Universidade Federal de Sao Carlos. Terminated at 2 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-12.
Sponsored by Universidade Federal de Sao Carlos · Phase 2, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 32 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Universidade Federal de Sao Carlos is the lead sponsor of 85 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of infection by SARS-CoV-2:
Exclusion Criteria:
Standard of care (SOC) treatment
Other: Standard of Care
SOC plus ivermectin 100 mcg/kg
Drug: Ivermectin
SOC plus ivermectin 200 mcg/kg
Drug: Ivermectin
SOC plus ivermectin 400 mcg/kg
Drug: Ivermectin
SOC plus different dosing regimens of Ivermectin
Standard treatment for COVID-19
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.
Plan to share: No
This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Universidade Federal de Sao Carlos