Covid19NCT05045937
Observational Study on the Use of Ivermectin as an Outpatient Treatment Option for COVID-19
An observational study of Covid19 and COVID-19 Pneumonia, run by Patrick Robinson at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, COVID-19 Pneumonia, COVID-19 Respiratory Infection
- What is being tested?
- Ivermectin
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 1 May 2024
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 110 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Patrick Robinson MD LLC
San Antonio, Florida, 33576
Patrick R Robinson, MD, 386-237-7150, mustang6374@yahoo.com
Dana M Robinson, RN, 8132156247, dmvkar143@gmail.com
About this study
Official title: Ivermectin Will be Used as an Outpatient Treatment Option for COVID-19 Patients.
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.
Read the 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.
- Being tested
- Ivermectin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
Also called Vitamin C, Vitamin D, Quercetin, Zinc
Ivermectin treatment of outpatients dosing at 0.4mg/kg until recovered along with supplemental treatment using a multi-modal approach.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 4-6 weeks per individual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 May 2022 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Patrick Robinson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patrick Robinson, Patrick Robinson MD LLC
- Investigators
- Patrick r Robinson, MD, Principal investigator, Patrick Robinson MD LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045937
- Sponsor's protocol ID
- Ivermectin Treatment Study #1
- Status last verified
- Apr 2022
- First submitted
- 14 Sep 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data may be shared at a later date once compiled.
Publications
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.
PubMed 32293834Trivedi 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.
PubMed 33336780Kaur 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.
PubMed 33389725Khan 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.
PubMed 33293006Ahmed 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.
PubMed 33278625Padhy 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.
PubMed 33227231Gupta 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.
PubMed 32615072Vallejos 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.
PubMed 33234158
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivermectin Will be Used as an Outpatient Treatment Option for COVID-19 Patients.
- ClinicalTrials.gov ID
- NCT05045937
- Acronym / sponsor ID
- Ivermectin Treatment Study #1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Patrick RobinsonUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients treated with Ivermectin | – | Drug: IvermectinThis 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. |
| 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. |
Who may qualify
- Ages
- 12 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvermectinAlso: Vitamin C, Vitamin D, Quercetin, ZincIvermectin treatment of outpatients dosing at 0.4mg/kg until recovered along with supplemental treatment using a multi-modal approach. | Drug | COVID-19 patients treated with Ivermectin |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Background: PubMed 32293834Simsek 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.
- Background: PubMed 33336780Trivedi 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.
- Results publication: PubMed 33389725Kaur 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.
- Results publication: PubMed 33293006Khan 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.
- Results publication: PubMed 33278625Ahmed 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.
- Results publication: PubMed 33227231Padhy 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.
- Results publication: PubMed 32615072Gupta 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.
- Results publication: PubMed 33234158Vallejos 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.
- Individual participant dataSharing planned: No. Individual patient data may be shared at a later date once compiled.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick r Robinson, MD principal investigator
Patrick Robinson MD LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and COVID-19 Pneumonia, run by Patrick Robinson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick R Robinson, MD (3862377150, mustang6374@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete recovery from COVID-19 with resolution of symptoms (time frame: 4-6 weeks per individual). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05045937, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.