Efficacy of Ivermectin in COVID-19

Sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05076253

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

24.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Safety SARS-CoV2 Infection Ivermectin Poisoning Effect of Drug	Drug: Ivermectin Drug: Placebo	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

a randomized ,double blind,placebo,controlled triala randomized ,double blind,placebo,controlled trial

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Group A: Ivermectin Group B: Placebo

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ivermectin Ivermectin 12 mg per day for 5 plus standard care	Drug: Ivermectin Ivermectin plus standard care Drug: Placebo Standard care
Placebo Comparator: Placebo Placebo plus standard care	Drug: Ivermectin Ivermectin plus standard care Drug: Placebo Standard care

Arm

Intervention/Treatment

Active Comparator: Ivermectin

Ivermectin 12 mg per day for 5 plus standard care

Drug: Ivermectin

Ivermectin plus standard care

Drug: Placebo

Standard care

Placebo Comparator: Placebo

Placebo plus standard care

Drug: Ivermectin

Ivermectin plus standard care

Drug: Placebo

Standard care

Outcome Measures

Primary Outcome Measures

Viral clearance of SARS- CoV-2 intervention [7 days]
Viral load from RT-PCR test
Viral clearance of SARS- CoV-2 intervention [14 days]
Viral load from RT-PCR test

Secondary Outcome Measures

Duration of hospitalization [28 days]
Day of hospitalization
frequency of clinical worsening [28 days]
numbers of cases that have clinical worsening
Mechanical ventilation [28 days]
numbers of cases that needs mechanical ventilation
Mortality rate [28 days]
numbers of cases that died

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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