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

Covid19 Clinical Trial

Official title:

Ivermectin Will be Used as an Outpatient Treatment Option for COVID-19 Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045937
• Other study ID #: Ivermectin Treatment Study #1
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2022
• Source: Patrick Robinson MD LLC
• Contact: Patrick R Robinson, MD
• Phone: 3862377150
• Email: mustang6374[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchitis
• COVID-19
• COVID-19 Pneumonia
• Covid19
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
United States	Patrick Robinson MD LLC	San Antonio	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Patrick Robinson

Country where clinical trial is conducted

United States, 

References & Publications (8)

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 In — View 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. — View Citation

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 — View 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 202 — View 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. — View Citation

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

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. Review. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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