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

NCT ID: NCT05045937

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-05-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Ivermectin

Intervention Type DRUG

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

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.

No interventions assigned to this group

Interventions

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Ivermectin

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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

* 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
Minimum Eligible Age

12 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Patrick Robinson

OTHER

Sponsor Role lead

Responsible Party

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Patrick Robinson

Chief Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Patrick r Robinson, MD

Role: PRINCIPAL_INVESTIGATOR

Patrick Robinson MD LLC

Locations

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Patrick Robinson MD LLC

San Antonio, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Patrick R Robinson, MD

Role: CONTACT

3862377150

Dana M Robinson, RN

Role: CONTACT

8132156247

Facility Contacts

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Patrick R Robinson, MD

Role: primary

386-237-7150

Dana M Robinson, RN

Role: backup

8132156247

References

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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.

Reference Type BACKGROUND
PMID: 32293834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33336780 (View on PubMed)

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.

Reference Type RESULT
PMID: 33389725 (View on PubMed)

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.

Reference Type RESULT
PMID: 33293006 (View on PubMed)

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.

Reference Type RESULT
PMID: 33278625 (View on PubMed)

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.

Reference Type RESULT
PMID: 33227231 (View on PubMed)

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.

Reference Type RESULT
PMID: 32615072 (View on PubMed)

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.

Reference Type RESULT
PMID: 33234158 (View on PubMed)

Other Identifiers

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Ivermectin Treatment Study #1

Identifier Type: -

Identifier Source: org_study_id

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