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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04431466
Recruitment Status : Terminated (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.)
First Posted : June 16, 2020
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
Henrique Pott Junior, Universidade Federal de Sao Carlos

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : July 1, 2020
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Undetectable viral load during 7 days of follow-up. [ Time Frame: 7 days following intervention ]
    Proportion of patients who achieved undetectable viral load during 7 days of follow-up.


Secondary Outcome Measures :
  1. Viral load variation in the nasopharyngeal swab. [ Time Frame: 7 days following intervention. ]
    Viral load variation in the nasopharyngeal swab during treatment.

  2. Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab. [ Time Frame: 7 days following intervention. ]
    Variation of serum lymphocyte counts during treatment.

  3. Incidence of Treatment-Emergent Self-reported Adverse Events [ Time Frame: 28 days following intervention. ]
    Incidence of Treatment-Emergent Adverse Events as assessed by clinical history and physical examination

  4. Incidence of Treatment-Emergent Laboratory-based Adverse Events [ Time Frame: 28 days following intervention. ]
    Incidence of Treatment-Emergent Adverse Events as assessed by laboratory tests


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04431466


Locations
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Brazil
Hospital Univeristário da Universidade Federal de São Carlos (HU-UFSCar)
São Carlos, São Paulo, Brazil, 13565-905
Hospital Universitário da Universidade Federal de São Carlos (HU-UFSCar)
São Carlos, São Paulo, Brazil, 13566-448
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Investigators
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Principal Investigator: Henrique Pott Junior, MD PhD Universidade Federal de Sao Carlos
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Henrique Pott Junior, Professor, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT04431466    
Other Study ID Numbers: IFORS
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Henrique Pott Junior, Universidade Federal de Sao Carlos:
coronavirus infections
SARS-CoV-2
COVID-19
ivermectin
clinical trial
Additional relevant MeSH terms:
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Infections
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Virus Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents