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

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: NCT05045937
Recruitment Status : Not yet recruiting
First Posted : September 16, 2021
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
Patrick Robinson, Patrick Robinson MD LLC

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.

Condition or disease Intervention/treatment
Covid19 COVID-19 Pneumonia COVID-19 Respiratory Infection COVID-19 Acute Bronchitis Drug: Ivermectin

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Ivermectin Will be Used as an Outpatient Treatment Option for COVID-19 Patients.
Estimated Study Start Date : September 20, 2021
Estimated Primary Completion Date : September 20, 2023
Estimated Study Completion Date : September 20, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

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:
  • 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.



Primary Outcome Measures :
  1. 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.

  2. 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



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.


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Ages Eligible for Study:   12 Years to 110 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Admitted under gender at birth
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

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): NCT05045937


Contacts
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Contact: Patrick R Robinson, MD 3862377150 mustang6374@yahoo.com
Contact: Dana M Robinson, RN 8132156247 dmvkar143@gmail.com

Locations
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United States, Florida
Patrick Robinson MD LLC
San Antonio, Florida, United States, 33576
Contact: Patrick R Robinson, MD    386-237-7150    mustang6374@yahoo.com   
Contact: Dana M Robinson, RN    8132156247    dmvkar143@gmail.com   
Sub-Investigator: Dana M Robinson, RN         
Sponsors and Collaborators
Patrick Robinson
Investigators
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Principal Investigator: Patrick r Robinson, MD Patrick Robinson MD LLC
Publications of Results:

Other Publications:
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Responsible Party: Patrick Robinson, Chief Investigator, Patrick Robinson MD LLC
ClinicalTrials.gov Identifier: NCT05045937    
Other Study ID Numbers: Ivermectin Treatment Study #1
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data may be shared at a later date once compiled.

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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:
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COVID-19
Bronchitis
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Vitamin D
Vitamins
Ivermectin
Remdesivir
Ibuprofen
Budesonide
Melatonin
Albuterol
Quercetin
Physiological Effects of Drugs
Micronutrients
Bone Density Conservation Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics