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Outpatient Use of Ivermectin in COVID‑19

Information provided by:

Temple University

Last updated:

05/26/2021

Trial identifier:

NCT04530474

Disclaimer

Study Description

Brief summary:

Covid 19, a novel coronavirus, causes infection that, while mild to moderate in many people, can lead to severe disease in a significant portion. Currently, it is expected that the majority, 81%, of patients with COVID-19 will have mild to moderate disease, with 14% having more severe disease (2). There exists a number of candidate drugs that may inhibit SARS-CoV-2 infection or progression of disease. Simple, safe and low-cost strategies that may be the best solution to inhibit infection and limit transmission and spread of infection. Ivermectin is a drug initially synthesized and used as an anthelmintic. It has been found to have activity against several RNA viruses such as the SARS-CoV-2 by mechanisms that inhibit importin α/β-mediated nuclear transport that may prevent viral proteins from entering the nucleus to alter host cell function. A recent in vitro study showed that a single dose of ivermectin could kill COVID-19 in vitro within 48 hours. A recent multi-continent retrospective study of 1,400 patients demonstrated an association of ivermectin use with lower in-hospital mortality 1.4% versus 8.5%. Given these findings and its safety profile, cost and ease of administration, Ivermectin warrants study as a potential treatment to prevent progression of COVID 19 infection.

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Official Title

Glossary term:

Title
The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.

Outpatient Use of Ivermectin in COVID-19

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Type of Study

Glossary term:

Study Type
Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access. Interventional studies (clinical trials): A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. Observational studies: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific intervention/treatment. A patient registry is a type of observational study. Expanded access: A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.

Interventional

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Enrollment (Actual)

Glossary term:

Enrollment
The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.

0

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Phase

Glossary term:

Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies). Phase 1: Clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants. Phase 2: Clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. Phase 3: Clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants. Phase 4: Clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use. Not Applicable: Trials without FDA-defined phases, including trials of devices or behavioral interventions.

Phase 3

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Other Study ID Numbers

Glossary term:

Other study IDs
Identifiers or ID numbers other than the NCT number that are assigned to a clinicalstudy by the study's sponsor, funders, or others. These numbers may include unique identifiers from othertrial registries and National Institutes of Health grant numbers.

1285242

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Intervention / Treatment

Glossary term:

Intervention/treatment
A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Drug: Ivermectin Pill
Drug: Placebo

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Study Start (Actual)

Glossary term:

Study start date
The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.

Apr 01, 2021

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Primary Completion (Anticipated)

Glossary term:

Primary completion date
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.

Jun 30, 2021

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Study Completion (Anticipated)

Glossary term:

Study completion date
The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.

Jun 30, 2021

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First Submitted Date

Glossary term:

First submitted
The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).

Aug 26, 2020

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First Submitted that Met QC Criteria

Glossary term:

First submitted that met QC criteria
The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

Aug 26, 2020

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First Posted (Actual)

Glossary term:

First posted
The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.

Aug 28, 2020

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Last Update Submitted that Met MQ Criteria

Glossary term:

Last update submitted that met QC criteria
The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

May 24, 2021

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Last Update Posted (Actual)

Glossary term:

Last update posted
The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date)and the last update posted date.

May 26, 2021

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Other important Dates

Contacts and Locations

Locations (1)

Contacts and Locations

Locations (1)


Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments. For general information about clinical research, read Guides to Clinical Trials.

Eligibility Criteria

Ages Eligible for Study:

Glossary term:

Age
A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth–17) Adult (18–64) Older adult (65+)

18 Years +

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Accepts Healthy Volunteers:

Glossary term:

Accepts Healthy Volunteers
A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.

No

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Sexes Eligible for Study:

Glossary term:

Sex
A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

All

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Description:

Inclusion Criteria:

  • Symptoms highly suspicious for COVID-19.
  • Age at least 18 years
  • Negative pregnancy test for women of child bearing age
  • Able to consent to participate in the study.

Exclusion Criteria:

  • Known history of Ivermectin allergy
  • Hypersensitivity to any component of Stromectol®
  • COVID-19 Pneumonia identified by chest X-ray or high resolution CT scan
  • Fever or cough present for more than 7 days
  • Positive IgG against SARS-CoV-2 by rapid test if available on baseline screening.
  • The following co-morbidities (or any other disease that, in the opinion of the investigators, might interfere with the study:
  • Immunosuppression
  • HIV
  • Acute or chronic renal failure
  • Current neoplasm
  • Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal within the prior 6 months if available OR clinical evidence of liver failure with jaundice, ascites, encephalopathy.
  • Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin.

Study Plan

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.

How is the study designed?

Design Details:
Primary Purpose:

Treatment

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Allocation:

Randomized

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Interventional Model:

Parallel Assignment

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Number of Arms:

2

Arms and Interventions:

Participant Group / Arm

Glossary term:

Arm
A group or subgroup of participants in a clinical trial that receives a specificintervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Glossary term:

Intervention/treatment
A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Experimental: Ivermectin

Single dose of 0.15-2 mg/kg/dose to a maximum of 12 mg

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Experimental: Ivermectin

Single dose of 0.15-2 mg/kg/dose to a maximum of 12 mg

Drug: Ivermectin Pill

Ivermecin as a one-time dose

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Drug: Ivermectin Pill

Ivermecin as a one-time dose

Placebo Comparator: Placebo

Single dose of 2-4 placebo pills

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Placebo Comparator: Placebo

Single dose of 2-4 placebo pills

Drug: Placebo

Inactive medication as a one time dose

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Drug: Placebo

Inactive medication as a one time dose

What is the study measuring?

Primary Outcome Measures

Glossary term:

Primary outcome measure
In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.

Outcome Measure

Clinical Improvement

Measure Description

Clinical Improvement as measured by the inFLUenza Patient-Reported Outcome (FLU-PRO)

Timeframe

28 days

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Outcome Measure
Measure Description
Timeframe

Clinical Improvement

Clinical Improvement as measured by the inFLUenza Patient-Reported Outcome (FLU-PRO)

28 days


Sponsor and Collaborators

The Sponsor of a study is the organization or person that is conducting the study. They may provide resources needed to do the investigation.

Sponsor:

Glossary term:

Sponsor
The organization or person who initiates the study and who has authority and control over the study.
  1. Temple University

Investigators and Collaborators

Investigators and Collaborators

Investigators:

Glossary term:

Investigator
A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
    Central Contacts:
Overall Officials:
Collaborators:

Glossary term:

Collaborator
An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.

More Information

Publications
Publications of Study Results
General Publications

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Publications Automatically Indexed to this Study by ClinicalTrials.Gov Identifier (NCT Number

No publications available

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