Efficacy of Ivermectin in COVID-19

NCT05076253 | Completed Phase 1 DMC

• 1 other identifier: 171/64
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Safety; SARS-CoV2 Infection; Ivermectin Poisoning; Effect of Drug

Keywords

efficacy; ivermectin; covid-19; randomised controlled trial

Outcome Measures

Primary Outcomes (2)

• Viral clearance of SARS- CoV-2 intervention

  Viral load from RT-PCR test

  7 days

• Viral clearance of SARS- CoV-2 intervention

  Viral load from RT-PCR test

  14 days

Secondary Outcomes (4)

• Duration of hospitalization

  28 days

• frequency of clinical worsening

  28 days

• Mechanical ventilation

  28 days

• Mortality rate

  28 days

Study Arms (2)

Ivermectin

ACTIVE COMPARATOR

Ivermectin 12 mg per day for 5 plus standard care

Drug: Ivermectin; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo plus standard care

Drug: Ivermectin; Drug: Placebo

Interventions

Ivermectin DRUG

Ivermectin plus standard care

Ivermectin; Placebo

Placebo DRUG

Standard care

Ivermectin; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangkok Metropolitan Administration Medical College and Vajira Hospital: lead

Study Sites (1)

Thananda Trakarnvanich

Bangkok, 10300, Thailand

Location

Related Publications (5)

• 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.

  PMID: 25130507 BACKGROUND

• 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.

  PMID: 29063617 BACKGROUND

• 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.

  PMID: 33293006 BACKGROUND

• 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.

  PMID: 33278625 BACKGROUND

• 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.

  PMID: 36028897 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Thananda Trakarnvanich, M.D.

  Bangkok Metropolitan Administration and Vajira Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Group A: Ivermectin Group B: Placebo
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: a randomized ,double blind,placebo,controlled trial

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 13, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication

Locations

TH (1)