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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

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 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

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
Intervention / Treatment
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

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

Patrick Robinson

Investigators

  • 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)

May 1, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

September 14, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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