Efficacy of Ivermectin in COVID-19

Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05076253
• Other study ID #: 171/64
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: Bangkok Metropolitan Administration Medical College and Vajira Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Effect of Drug
• Infections
• Ivermectin Poisoning
• Poisoning
• Safety
• SARS-CoV2 Infection

Intervention

Drug:
• Ivermectin
Ivermectin plus standard care
• Placebo
Standard care

Locations

Country	Name	City	State
Thailand	Thananda Trakarnvanich	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Bangkok Metropolitan Administration Medical College and Vajira Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

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. — View Citation

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. Review. — 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 2020 Sep 24. English, Spanish. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral clearance of SARS- CoV-2 intervention	Viral load from RT-PCR test	7 days
Primary	Viral clearance of SARS- CoV-2 intervention	Viral load from RT-PCR test	14 days
Secondary	Duration of hospitalization	Day of hospitalization	28 days
Secondary	frequency of clinical worsening	numbers of cases that have clinical worsening	28 days
Secondary	Mechanical ventilation	numbers of cases that needs mechanical ventilation	28 days
Secondary	Mortality rate	numbers of cases that died	28 days