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Efficacy of Ivermectin in COVID-19

NCT ID: NCT05076253

Last Updated: 2021-12-15

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2021-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Safety SARS-CoV2 Infection Ivermectin Poisoning Effect of Drug

Keywords

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efficacy ivermectin covid-19 randomised controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

a randomized ,double blind,placebo,controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Group A: Ivermectin Group B: Placebo

Study Groups

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Ivermectin

Ivermectin 12 mg per day for 5 plus standard care

Group Type ACTIVE_COMPARATOR

Ivermectin

Intervention Type DRUG

Ivermectin plus standard care

Placebo

Intervention Type DRUG

Standard care

Placebo

Placebo plus standard care

Group Type PLACEBO_COMPARATOR

Ivermectin

Intervention Type DRUG

Ivermectin plus standard care

Placebo

Intervention Type DRUG

Standard care

Interventions

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Ivermectin

Ivermectin plus standard care

Intervention Type DRUG

Placebo

Standard care

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bangkok Metropolitan Administration Medical College and Vajira Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Thananda Trakarnvanich

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thananda Trakarnvanich, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bangkok Metropolitan Administration and Vajira Hospital

Locations

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Thananda Trakarnvanich

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 25130507 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29063617 (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 BACKGROUND
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 BACKGROUND
PMID: 33278625 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36028897 (View on PubMed)

Other Identifiers

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171/64

Identifier Type: -

Identifier Source: org_study_id