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

NCT05045937 | Unknown FDA Drug

• 1 other identifier: Ivermectin Treatment Study #1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; COVID-19 Pneumonia; COVID-19 Respiratory Infection; COVID-19 Acute Bronchitis

Outcome Measures

Primary Outcomes (2)

• Complete recovery from COVID-19 with resolution of symptoms

  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

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

  4-6 weeks per individual

Study Arms (2)

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

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.

Interventions

Ivermectin DRUG

Ivermectin treatment of outpatients dosing at 0.4mg/kg until recovered along with supplemental treatment using a multi-modal approach.

Also known as: Vitamin C, Vitamin D, Quercetin, Zinc, Budesonide, Aspirin, Tylenol, Ibuprofen, IV Infusion, Monoclonal Antibodies, COVID Vaccine, Melatonin, Niacin, Albuterol, Remdesivir

COVID-19 patients treated with Ivermectin

Eligibility Criteria

• Age: 12 Years - 110 Years
• Gender Eligibility Details: Admitted under gender at birth
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Patrick Robinson: lead

Study Sites (1)

Patrick Robinson MD LLC

San Antonio, Florida, 33576, United States

RECRUITING

Related Publications (8)

• Simsek Yavuz S, Unal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619. doi: 10.3906/sag-2004-145.

  PMID: 32293834 BACKGROUND

• Trivedi N, Verma A, Kumar D. Possible treatment and strategies for COVID-19: review and assessment. Eur Rev Med Pharmacol Sci. 2020 Dec;24(23):12593-12608. doi: 10.26355/eurrev_202012_24057.

  PMID: 33336780 BACKGROUND

• Kaur H, Shekhar N, Sharma S, Sarma P, Prakash A, Medhi B. Ivermectin as a potential drug for treatment of COVID-19: an in-sync review with clinical and computational attributes. Pharmacol Rep. 2021 Jun;73(3):736-749. doi: 10.1007/s43440-020-00195-y. Epub 2021 Jan 3.

  PMID: 33389725 RESULT

• Khan MSI, Khan MSI, Debnath CR, Nath PN, Mahtab MA, Nabeka H, Matsuda S, Akbar SMF. Ivermectin Treatment May Improve the Prognosis of Patients With COVID-19. Arch Bronconeumol (Engl Ed). 2020 Dec;56(12):828-830. doi: 10.1016/j.arbres.2020.08.007. Epub 2020 Sep 24. No abstract available.

  PMID: 33293006 RESULT

• Ahmed S, Karim MM, Ross AG, Hossain MS, Clemens JD, Sumiya MK, Phru CS, Rahman M, Zaman K, Somani J, Yasmin R, Hasnat MA, Kabir A, Aziz AB, Khan WA. A five-day course of ivermectin for the treatment of COVID-19 may reduce the duration of illness. Int J Infect Dis. 2021 Feb;103:214-216. doi: 10.1016/j.ijid.2020.11.191. Epub 2020 Dec 2.

  PMID: 33278625 RESULT

• Padhy BM, Mohanty RR, Das S, Meher BR. Therapeutic potential of ivermectin as add on treatment in COVID 19: A systematic review and meta-analysis. J Pharm Pharm Sci. 2020;23:462-469. doi: 10.18433/jpps31457.

  PMID: 33227231 RESULT

• Gupta D, Sahoo AK, Singh A. Ivermectin: potential candidate for the treatment of Covid 19. Braz J Infect Dis. 2020 Jul-Aug;24(4):369-371. doi: 10.1016/j.bjid.2020.06.002. Epub 2020 Jun 28. No abstract available.

  PMID: 32615072 RESULT

• Vallejos J, Zoni R, Bangher M, Villamandos S, Bobadilla A, Plano F, Campias C, Chaparro Campias E, Achinelli F, Guglielmone HA, Ojeda J, Medina F, Farizano Salazar D, Andino G, Ruiz Diaz NE, Kawerin P, Meza E, Dellamea S, Aquino A, Flores V, Martemucci CN, Vernengo MM, Martinez SM, Segovia JE, Aguirre MG. Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19): a structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Nov 24;21(1):965. doi: 10.1186/s13063-020-04813-1.

  PMID: 33234158 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin; Ascorbic Acid; Vitamin D; Quercetin; Zinc; Budesonide; Aspirin; Acetaminophen; Ibuprofen; Infusions, Intravenous; Antibodies, Monoclonal; Melatonin; Niacin; Albuterol; remdesivir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Pregnenediones; Pregnenes; Pregnanes; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Tryptamines; Indoles; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Ethanolamines; Amino Alcohols; Alcohols; Phenethylamines; Ethylamines

Study Officials

• Patrick r Robinson, MD

  Patrick Robinson MD LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick R Robinson, MD

CONTACT

3862377150; mustang6374@yahoo.com

Dana M Robinson, RN

CONTACT

8132156247; dmvkar143@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 16, 2021
• Study Start: May 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)