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

Sponsor
Patrick Robinson (Other)
Overall Status
Recruiting
CT.gov ID
NCT05045937
Collaborator
(none)
1,000
1
24
41.6

Study Details

Study Description

Brief Summary

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.

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Ivermectin Will be Used as an Outpatient Treatment Option for COVID-19 Patients.
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm 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:
  • Vitamin C
  • Vitamin D
  • Quercetin
  • Zinc
  • Budesonide
  • Aspirin
  • Tylenol
  • Ibuprofen
  • IV Infusion
  • Monoclonal Antibodies
  • COVID Vaccine
  • Melatonin
  • Niacin
  • Albuterol
  • Remdesivir
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Complete recovery from COVID-19 with resolution of symptoms [4-6 weeks per individual]

      This group recovered completely from COVID-19 and remained an outpatient throughout the duration of their illness.

    2. Admission to a hospital for further advanced treatment [4-6 weeks per individual]

      This group of patients was unable to recover at home and required hospital admission

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 110 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Patrick Robinson MD LLC San Antonio Florida United States 33576

    Sponsors and Collaborators

    • Patrick Robinson

    Investigators

    • Principal Investigator: Patrick r Robinson, MD, Patrick Robinson MD LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Patrick Robinson, Chief Investigator, Patrick Robinson MD LLC
    ClinicalTrials.gov Identifier:
    NCT05045937
    Other Study ID Numbers:
    • Ivermectin Treatment Study #1
    First Posted:
    Sep 16, 2021
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 27, 2022