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SafetyPhase 1/2NCT05076253

Efficacy of Ivermectin in COVID-19

A Phase 1/2 study testing Ivermectin in people with Safety and SARS-CoV2 Infection, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The newly emerged corona virus disease 2019 (COVID-19) has spread to all over the world, with recent estimates of more than 236 million cases diagnosed and led to 4.8 million deaths as November 20211 .Therapeutic approaches are needed to improve outcomes in patients with COVID-19 since no antiviral agent has yet been… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Safety, SARS-CoV2 Infection, Ivermectin Poisoning
What is being tested?
Ivermectin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteThailand
Study dates
1 Sep 2021to 1 Dec 2021
Phase
Phase 1/2
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult men and women age 18-80 years
  • non-pregnant or breast-feeding women
  • had mild to moderate symptoms as defined by the World Health Organization (WHO) severity score for COVID-19 Mild disease was defined as cough , runny nose,anosmia, fever, diarrhea without dyspnea or tachypnea.
  • Moderate disease was defined as pneumonia but with oxygen saturation more than 90 percent

Who cannot join

  • were allergic to ivermectin
  • have the potential for a drug-drug interaction with ivermectin such as tamoxifen or warfarin
  • previously treated with ivermectin in the last 7 days
  • had received any herbal medicine
  • had severe chronic illness (severe congestive heart failure, chronic kidney disease stage 4-5, chronic liver disease, terminal cancer diseases)
  • had concurrent bacterial infection or unwilling to participate in the trial
  • Patients with severe symptoms, likely due to cytokine release syndrome
  • uncontrolled co-morbidities and immunocompromised states

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Thananda Trakarnvanich

    Bangkok, 10300

Other trials in Thailand

About this study

Official title: Efficacy and Safety of Ivermectin in Treatment of Mild to Moderate COVID-19 Infection: a Randomized ,Double Blind,Placebo,Controlled Trial

The newly emerged corona virus disease 2019 (COVID-19) has spread to all over the world, with recent estimates of more than 236 million cases diagnosed and led to 4.8 million deaths as November 20211 .Therapeutic approaches are needed to improve outcomes in patients with COVID-19 since no antiviral agent has yet been proved to be conclusively beneficial in COVID-19 infection,especially in patients with mild to moderate degree of severity There has been growing interest in the anti-parasitic drug,ivermectin, which previously was studied as an antiviral, anti-inflammatory and anti-cancer actions2 .It was also reported to have an in-vitro activity against SARS-CoV-23 .Its antiviral properties was due to the action on importin 2/1 mediated nuclear transport. Ivermectin prevents the binding of viral proteins to importin 2/1 rendering the viral proteins unable to enter the nucleus and cause infection4.

Several clinical studies have found a beneficial effect of ivermectin in COVID-195-9 However, some study did not find significant difference between the patient group receiving ivermectin and control group10 .Until now, the controlled trials evaluating ivermectin in COVID-19 are lacking. Ivermectin is safe, with reported side effect of less than 1%. Hence it is essential to conduct a clinical trial with ivermectin in patients with COVID-19 .The objective of this study is to establish the efficacy of ivermectin for COVID-19 patients with mild to moderate disease, compare to usual case alone.

Read the detailed description

This study is a randomized, double-blind, placebo controlled trial conducted at Faculty of Medicine, Vajira Hospital, Navamindradhiraj University from September 2021 to the end of November 2021.

The patients were randomized in permuted block of four in a randomized sequence prepared by the unblinded pharmacist in Microsoft excel12 .Allocation assignment was concealed from investigators and the patients. The patients were allocated into two groups : either to group A (Ivermectin arm) or to group B (control arm) as shown in Fig 1. The patients were randomized in a 1:1 ratio .Group A received ivermectin 12 mg per day for 5 days as recommended by previous studes13,14 plus standard care. Group B was to receive standard care alone which included favipiravir or andrographolide, corticosteroids, cetrizine and paracetamol.

Being tested
Ivermectin, Placebo
Keywords
efficacy, ivermectin, covid-19, randomised controlled trial
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

    Ivermectin plus standard care

  • PlaceboDrug

    Standard care

Study groups in NCT05076253
Study groupRoleWhat they receive
IvermectinActive comparatorIvermectin 12 mg per day for 5 plus standard care
Receives: Drug: Ivermectin; Drug: Placebo
PlaceboPlacebo comparatorPlacebo plus standard care
Receives: Drug: Ivermectin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Viral clearance of SARS- CoV-2 intervention

    Viral load from RT-PCR test

    Measured: 7 days

  2. Viral clearance of SARS- CoV-2 intervention

    Viral load from RT-PCR test

    Measured: 14 days

Secondary outcomes (4)

  1. Duration of hospitalization

    Day of hospitalization

    Measured: 28 days

  2. frequency of clinical worsening

    numbers of cases that have clinical worsening

    Measured: 28 days

  3. Mechanical ventilation

    numbers of cases that needs mechanical ventilation

    Measured: 28 days

  4. Mortality rate

    numbers of cases that died

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2021
  2. Study start1 Sep 2021
  3. Primary completion1 Dec 2021
  4. Study completion1 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
a randomized ,double blind,placebo,controlled trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05076253
Sponsor's protocol ID
171/64
Status last verified
Dec 2021
First submitted
8 Oct 2021
Last updated
15 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be made available upon request after publication

Publications

  • Omura S, Crump A. Ivermectin: panacea for resource-poor communities? Trends Parasitol. 2014 Sep;30(9):445-55. doi: 10.1016/j.pt.2014.07.005. Epub 2014 Aug 12.

    PubMed 25130507

  • Chen IS, Kubo Y. Ivermectin and its target molecules: shared and unique modulation mechanisms of ion channels and receptors by ivermectin. J Physiol. 2018 May 15;596(10):1833-1845. doi: 10.1113/JP275236. Epub 2017 Nov 9.

    PubMed 29063617

  • 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.

    PubMed 33293006

  • 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.

    PubMed 33278625

  • Manomaipiboon A, Pholtawornkulchai K, Poopipatpab S, Suraamornkul S, Maneerit J, Ruksakul W, Phumisantiphong U, Trakarnvanich T. Efficacy and safety of ivermectin in the treatment of mild to moderate COVID-19 infection: a randomized, double-blind, placebo-controlled trial. Trials. 2022 Aug 26;23(1):714. doi: 10.1186/s13063-022-06649-3.

    PubMed 36028897

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ivermectin in people with Safety and SARS-CoV2 Infection, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.

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 4 inclusion and 8 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: finished, as of the sponsor's last update on 15 Dec 2021. 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 Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Viral clearance of SARS- CoV-2 intervention (time frame: 7 days). 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 NCT05076253, which also lists 5 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 15 Dec 2021.

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