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

Primary Purpose

Coronavirus Infection

Status

Terminated

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Ivermectin

Standard of Care

About this trial

This is an interventional treatment trial for Coronavirus Infection focused on measuring coronavirus infections, SARS-CoV-2, COVID-19, ivermectin, clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of infection by SARS-CoV-2:
1. 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
2. any acute respiratory disease AND biomolecular diagnosis of SARS-CoV-2 infection; OR
3. 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Standard of care

SOC plus ivermectin 100 mcg/kg

SOC plus ivermectin 200 mcg/kg

SOC plus ivermectin 400 mcg/kg

Arm Description

Standard of care (SOC) treatment

SOC plus ivermectin 100 mcg/kg

SOC plus ivermectin 200 mcg/kg

SOC plus ivermectin 400 mcg/kg

Outcomes

Primary Outcome Measures

Undetectable viral load during 7 days of follow-up.

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

Secondary Outcome Measures

Viral load variation in the nasopharyngeal swab.

Viral load variation in the nasopharyngeal swab during treatment.

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

Variation of serum lymphocyte counts during treatment.

Incidence of Treatment-Emergent Self-reported Adverse Events

Incidence of Treatment-Emergent Adverse Events as assessed by clinical history and physical examination

Incidence of Treatment-Emergent Laboratory-based Adverse Events

Incidence of Treatment-Emergent Adverse Events as assessed by laboratory tests

Full Information

NCT ID

NCT04431466

First Posted

June 10, 2020

Last Updated

October 7, 2021

Sponsor

Universidade Federal de Sao Carlos

1. Study Identification

Unique Protocol Identification Number

NCT04431466

Brief Title

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

Acronym

IFORS

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Terminated

Why Stopped

Preliminary data from a pilot study suggest that the administration of ivermectin in patients with SARS-CoV-2 is safe, reducing symptoms and viral load. The antiviral effects of ivermectin appear to depend on the dose administered.

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

December 1, 2020 (Actual)

Study Completion Date

December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Federal de Sao Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Infection

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of care

Arm Type

Active Comparator

Arm Description

Standard of care (SOC) treatment

Arm Title

SOC plus ivermectin 100 mcg/kg

Arm Type

Experimental

Arm Description

SOC plus ivermectin 100 mcg/kg

Arm Title

SOC plus ivermectin 200 mcg/kg

Arm Type

Experimental

Arm Description

SOC plus ivermectin 200 mcg/kg

Arm Title

SOC plus ivermectin 400 mcg/kg

Arm Type

Experimental

Arm Description

SOC plus ivermectin 400 mcg/kg

Intervention Type

Drug

Intervention Name(s)

Ivermectin

Intervention Description

SOC plus different dosing regimens of Ivermectin

Intervention Type

Other

Intervention Name(s)

Standard of Care

Intervention Description

Standard treatment for COVID-19

Primary Outcome Measure Information:

Title

Undetectable viral load during 7 days of follow-up.

Description

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

Time Frame

7 days following intervention

Secondary Outcome Measure Information:

Title

Viral load variation in the nasopharyngeal swab.

Description

Viral load variation in the nasopharyngeal swab during treatment.

Time Frame

7 days following intervention.

Title

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

Description

Variation of serum lymphocyte counts during treatment.

Time Frame

7 days following intervention.

Title

Incidence of Treatment-Emergent Self-reported Adverse Events

Description

Incidence of Treatment-Emergent Adverse Events as assessed by clinical history and physical examination

Time Frame

28 days following intervention.

Title

Incidence of Treatment-Emergent Laboratory-based Adverse Events

Description

Incidence of Treatment-Emergent Adverse Events as assessed by laboratory tests

Time Frame

28 days following intervention.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henrique Pott Junior, MD PhD

Organizational Affiliation

Universidade Federal de Sao Carlos

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

São Carlos

State/Province

São Paulo

ZIP/Postal Code

13565-905

Country

Brazil

Facility Name

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

City

São Carlos

State/Province

São Paulo

ZIP/Postal Code

13566-448

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33723507

Citation

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.

Results Reference

derived

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

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