Efficacy of Ivermectin in COVID-19

December 14, 2021 updated by: Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10300
        • Thananda Trakarnvanich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral clearance of SARS- CoV-2 intervention
Time Frame: 7 days
Viral load from RT-PCR test
7 days
Viral clearance of SARS- CoV-2 intervention
Time Frame: 14 days
Viral load from RT-PCR test
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of hospitalization
Time Frame: 28 days
Day of hospitalization
28 days
frequency of clinical worsening
Time Frame: 28 days
numbers of cases that have clinical worsening
28 days
Mechanical ventilation
Time Frame: 28 days
numbers of cases that needs mechanical ventilation
28 days
Mortality rate
Time Frame: 28 days
numbers of cases that died
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Investigators

  • Principal Investigator: Thananda Trakarnvanich, M.D., Bangkok Metropolitan Administration and Vajira Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

December 15, 2021

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 171/64

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be made available upon request after publication

IPD Sharing Time Frame

After publication

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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