Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04431466
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Henrique Pott Junior, Universidade Federal de Sao Carlos

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 treatment for COVID-19 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 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
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arm Intervention/treatment
Active Comparator: Standard treatment
Standard treatment for COVID-19
Other: Standard treatment for COVID-19
Standard treatment for COVID-19

Experimental: Ivermectin lower single-dose
Ivermectin 100mcg / kg PO single dose
Drug: Ivermectin
This clinical trial will evaluate the efficacy between different ivermectin dosing schedules (100mcg / kg PO single dose; 100mcg / kg PO on the first day, followed by 100mcg / kg PO after 72h; 200mcg / kg PO single dose; and 200mcg / kg on the first day, followed by 200mcg / kg PO after) for the treatment of individuals with diagnosis SARS-CoV-2 infection.

Experimental: Ivermectin lower repeated-dose
100mcg / kg PO on the first day, followed by 100mcg / kg PO after 72h
Drug: Ivermectin
This clinical trial will evaluate the efficacy between different ivermectin dosing schedules (100mcg / kg PO single dose; 100mcg / kg PO on the first day, followed by 100mcg / kg PO after 72h; 200mcg / kg PO single dose; and 200mcg / kg on the first day, followed by 200mcg / kg PO after) for the treatment of individuals with diagnosis SARS-CoV-2 infection.

Experimental: Ivermectin higher single-dose
Ivermectin 200mcg / kg PO single dose
Drug: Ivermectin
This clinical trial will evaluate the efficacy between different ivermectin dosing schedules (100mcg / kg PO single dose; 100mcg / kg PO on the first day, followed by 100mcg / kg PO after 72h; 200mcg / kg PO single dose; and 200mcg / kg on the first day, followed by 200mcg / kg PO after) for the treatment of individuals with diagnosis SARS-CoV-2 infection.

Experimental: Ivermectin higher repeated-dose
200mcg / kg PO on the first day, followed by 200mcg / kg PO after 72h
Drug: Ivermectin
This clinical trial will evaluate the efficacy between different ivermectin dosing schedules (100mcg / kg PO single dose; 100mcg / kg PO on the first day, followed by 100mcg / kg PO after 72h; 200mcg / kg PO single dose; and 200mcg / kg on the first day, followed by 200mcg / kg PO after) for the treatment of individuals with diagnosis SARS-CoV-2 infection.




Primary Outcome Measures :
  1. Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab. [ Time Frame: 7 days following intervention ]
    Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab after Intervention Initiation.


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. Proportion of patients with undetectable SARS-CoV-2 viral load in the nasopharyngeal swab. [ Time Frame: 7 after intervention. ]
    Proportion of patients with undetectable SARS-CoV-2 viral load in the nasopharyngeal swab at the end of follow-up.

  4. Proportion of patients with clinical improvement. [ Time Frame: 7 after intervention. ]
    Proportion of patients with clinical improvement, defined as the time to normalize fever, respiratory rate and oxygen saturation and cough relief at the end of follow-up.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

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


Contacts
Layout table for location contacts
Contact: Henrique Pott Junior, MD PhD +55 16 3351-8340 henriquepott@ufscar.br

Locations
Layout table for location information
Brazil
Hospital Univeristário da Universidade Federal de São Carlos (HU-UFSCar) Not yet recruiting
São Carlos, São Paulo, Brazil, 13565-905
Contact: Henrique Pott Junior, MD PhD       henriquepott@ufscar.br   
Hospital Universitário da Universidade Federal de São Carlos (HU-UFSCar) Recruiting
São Carlos, São Paulo, Brazil, 13566-448
Contact: Henrique Pott Junior, MD PhD       henriquepott@ufscar.br   
Principal Investigator: Henrique Pott Junior, MD PhD         
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Investigators
Layout table for investigator information
Principal Investigator: Henrique Pott Junior, MD PhD Universidade Federal de Sao Carlos
Additional Information:
Layout table for additonal information
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: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Ivermectin
Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiparasitic Agents
Anti-Infective Agents