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

Sponsor

Universidade Federal de Sao Carlos (Other)

Overall Status

Terminated

CT.gov ID

NCT04431466

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infection	Drug: Ivermectin Other: Standard of Care	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 2 Clinical Trial to Compare the Efficacy and Safety of Different Doses of Ivermectin in Patients Diagnosed With the New Coronavirus Infection (SARS-CoV-2)

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of care Standard of care (SOC) treatment	Other: Standard of Care Standard treatment for COVID-19
Experimental: SOC plus ivermectin 100 mcg/kg SOC plus ivermectin 100 mcg/kg	Drug: Ivermectin SOC plus different dosing regimens of Ivermectin
Experimental: SOC plus ivermectin 200 mcg/kg SOC plus ivermectin 200 mcg/kg	Drug: Ivermectin SOC plus different dosing regimens of Ivermectin
Experimental: SOC plus ivermectin 400 mcg/kg SOC plus ivermectin 400 mcg/kg	Drug: Ivermectin SOC plus different dosing regimens of Ivermectin

Outcome Measures

Primary Outcome Measures

Undetectable viral load during 7 days of follow-up. [7 days following intervention]
Proportion of patients who achieved undetectable viral load during 7 days of follow-up.

Secondary Outcome Measures

Viral load variation in the nasopharyngeal swab. [7 days following intervention.]
Viral load variation in the nasopharyngeal swab during treatment.
Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab. [7 days following intervention.]
Variation of serum lymphocyte counts during treatment.
Incidence of Treatment-Emergent Self-reported Adverse Events [28 days following intervention.]
Incidence of Treatment-Emergent Adverse Events as assessed by clinical history and physical examination
Incidence of Treatment-Emergent Laboratory-based Adverse Events [28 days following intervention.]
Incidence of Treatment-Emergent Adverse Events as assessed by laboratory tests

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Univeristário da Universidade Federal de São Carlos (HU-UFSCar)	São Carlos	São Paulo	Brazil	13565-905
2	Hospital Universitário da Universidade Federal de São Carlos (HU-UFSCar)	São Carlos	São Paulo	Brazil	13566-448