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

NCT04431466 | Terminated Phase 2 DMC

• 1 other identifier: IFORS
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

coronavirus infections; SARS-CoV-2; COVID-19; ivermectin; clinical trial

Outcome Measures

Primary Outcomes (1)

• Undetectable viral load during 7 days of follow-up.

  Proportion of patients who achieved undetectable viral load during 7 days of follow-up.

  7 days following intervention

Secondary Outcomes (4)

• Viral load variation in the nasopharyngeal swab.

  7 days following intervention.

• Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab.

  7 days following intervention.

• Incidence of Treatment-Emergent Self-reported Adverse Events

  28 days following intervention.

• Incidence of Treatment-Emergent Laboratory-based Adverse Events

  28 days following intervention.

Study Arms (4)

Standard of care

ACTIVE COMPARATOR

Standard of care (SOC) treatment

Other: Standard of Care

SOC plus ivermectin 100 mcg/kg

EXPERIMENTAL

SOC plus ivermectin 100 mcg/kg

Drug: Ivermectin

SOC plus ivermectin 200 mcg/kg

EXPERIMENTAL

SOC plus ivermectin 200 mcg/kg

Drug: Ivermectin

SOC plus ivermectin 400 mcg/kg

EXPERIMENTAL

SOC plus ivermectin 400 mcg/kg

Drug: Ivermectin

Interventions

Ivermectin DRUG

SOC plus different dosing regimens of Ivermectin

SOC plus ivermectin 100 mcg/kg; SOC plus ivermectin 200 mcg/kg; SOC plus ivermectin 400 mcg/kg

Standard of Care OTHER

Standard treatment for COVID-19

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of infection by SARS-CoV-2:
• symptoms of acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath) and biomolecular diagnosis of SARS-CoV-2 infection; OR
• any acute respiratory disease AND biomolecular diagnosis of SARS-CoV-2 infection; OR
• severe acute respiratory infection (fever and at least one sign / symptom of respiratory disease eg cough, fever, shortness of breath) AND in need of hospitalization AND biomolecular diagnosis of SARS-CoV-2 infection;
• Eastern Cooperative Oncology Group Performance Status score 0 to 1;
• National Early Warning Score 0 to 4;
• Ability to understand and consent to participate in this clinical trial, manifested by signing the Informed Consent Form (ICF).

You may not qualify if:

• Inability to ingest / absorb the study drug orally through spontaneous ingestion or use of gastro / enteral tubes;
• Any finding of clinical observation (history / physical evaluation) that is interpreted by the investigating physician as a risk to participate in the trial;
• Any laboratory test findings that the investigating physician considers as a risk to the research participant as to his / her participation in the clinical study;
• Any ECG examination finding that the investigating physician considers as a risk to the research participant as to his / her participation in the trial;
• Known hypersensitivity to the components of the drugs used during the study;
• Women in pregnancy or breastfeeding;
• Body weight less than 15kg;
• Estimated glomerular filtration rate (CKD-Epidemiology Collaboration, CKD-EPI) \<30 mL / min;
• Aspartate aminotransaminase (AST) or alanine aminotransaminase (ALT)\> 5 times the upper limit of normality;
• Refusal to participate;
• Refusal to sign the informed consent form.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (2)

Hospital Univeristário da Universidade Federal de São Carlos (HU-UFSCar)

São Carlos, São Paulo, 13565-905, Brazil

Location

Hospital Universitário da Universidade Federal de São Carlos (HU-UFSCar)

São Carlos, São Paulo, 13566-448, Brazil

Location

Related Publications (1)

• Pott-Junior H, Paoliello MMB, Miguel AQC, da Cunha AF, de Melo Freire CC, Neves FF, da Silva de Avo LR, Roscani MG, Dos Santos SS, Chacha SGF. Use of ivermectin in the treatment of Covid-19: A pilot trial. Toxicol Rep. 2021;8:505-510. doi: 10.1016/j.toxrep.2021.03.003. Epub 2021 Mar 9.

  PMID: 33723507 DERIVED

Related Links

• Hospital Universitário da UFSCar

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Ivermectin; Standard of Care

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Henrique Pott Junior, MD PhD

  Universidade Federal de Sao Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 16, 2020
• Study Start: July 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)