Clinical trial NCT05045937: Observational Study on the Use of Ivermectin as an Outpatient Treatment Option for COVID-19
Official title: Ivermectin Will be Used as an Outpatient Treatment Option for COVID-19 Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
COVID-19 Pneumonia
COVID-19 Respiratory Infection
COVID-19 Acute Bronchitis
Lead sponsor: Patrick Robinson MD LLC
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Complete recovery from COVID-19 with resolution of symptoms
timeFrame: 4-6 weeks per individual
measure: Admission to a hospital for further advanced treatment
timeFrame: 4-6 weeks per individual
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Patrick Robinson MD LLC
state: Florida
Study officials:
affiliation: Patrick Robinson MD LLC
name: Patrick r Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.