Observational Study on the Use of Ivermectin as an Outpatient Treatment Option for COVID-19

April 25, 2022 updated by: Patrick Robinson

Ivermectin Will be Used as an Outpatient Treatment Option for COVID-19 Patients.

Ivermectin is currently being utilized by a number of physicians in the local area. My objective will be to enroll these patients at the time of their evaluation for COVID-19 infection and to follow their progress through their recovery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

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.

Detailed Description

Patients at local physician clinics as well as my own clinic will be enrolled at the time they are evaluated for having COVID-19. Patients enrollment will be voluntary and based upon their request for treatment with Ivermectin. These patients will be questioned on symptoms and the timing of those symptoms in detail. They will then be followed throughout their treatment course to evaluate their recovery experience. Detailed accounts of their symptoms and their resolution will be followed. The study patients will stop being followed when they are either admitted to the hospital or are deemed to be symptom free. Any other medications prescribed to the patients will also be tracked. Medical histories will be taken and documented to make comparisons at the end of the study. Those patients not requesting Ivermectin will also be followed for comparisons at a later date.

Study Type

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.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • San Antonio, Florida, United States, 33576
        • Recruiting
        • Patrick Robinson MD LLC
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dana M Robinson, RN

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 110 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All individuals presenting to various health clinics who are COVID positive and requesting treatment. Although the primary focus is on the effectiveness of Ivermectin for treatment, those not requesting Ivermectin treatment will be followed in a separate group.

Description

Inclusion Criteria:

  • Between the ages of 12-110 years old
  • Has a recently completed COVID test
  • Symptomatic and seeking treatment
  • Willingness to participate and have follow-up
  • Able and willing to take medications and treatment suggestions from the physician

Exclusion Criteria: Lack of symptoms, uncertain of COVID-19 status, outside of age limits for treatment

  • No recent COVID test results
  • Asymptomatic, even if COVID positive
  • Outside of acceptable age range
  • Meets criteria for hospital admission
  • Unwilling to participate in trial study or have follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

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.
COVID-19 patients treated with Ivermectin
This group of patients will be those who requested to be treated with Ivermectin and whom have been prescribed such by different physicians. This group may or may not include those treated with Monoclonal Antibodies or Remdesivir.
Drug: Ivermectin
Ivermectin treatment of outpatients dosing at 0.4mg/kg until recovered along with supplemental treatment using a multi-modal approach.
Other Names:
  • Tylenol
  • Vitamin D
  • Budesonide
  • Aspirin
  • Vitamin C
  • Ibuprofen
  • Melatonin
  • Albuterol
  • Remdesivir
  • Zinc
  • Niacin
  • Quercetin
  • IV Infusion
  • Monoclonal Antibodies
  • COVID Vaccine
COVID-19 patients declining Ivermectin and wanting traditional treatment
This group of patients will be those who do not request to be treated with Ivermerctin and who want to be treated with a more traditional, minimalist approach. This group may or may not include those treated with Monoclonal Antibodies or Remdesivir.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

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
Measure Description
Time Frame
Complete recovery from COVID-19 with resolution of symptoms
Time Frame: 4-6 weeks per individual
This group recovered completely from COVID-19 and remained an outpatient throughout the duration of their illness.
4-6 weeks per individual
Admission to a hospital for further advanced treatment
Time Frame: 4-6 weeks per individual
This group of patients was unable to recover at home and required hospital admission
4-6 weeks per individual

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Patrick Robinson

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrick r Robinson, MD, Patrick Robinson MD LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Anticipated)

Primary Completion

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 "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Anticipated)

Study Completion

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 "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

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).
September 14, 2021

First Submitted That Met QC Criteria

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.
September 14, 2021

First Posted (Actual)

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.
September 16, 2021

Study Record Updates

Last Update Posted (Actual)

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.
April 27, 2022

Last Update Submitted That Met QC Criteria

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.
April 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ivermectin Treatment Study #1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual patient data may be shared at a later date once compiled.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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