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Efficacy of Ivermectin in COVID-19

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ClinicalTrials.gov Identifier: NCT05076253
Recruitment Status : Recruiting
First Posted : October 13, 2021
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: a 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 : September 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

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




Primary Outcome Measures :
  1. Viral clearance of SARS- CoV-2 intervention [ Time Frame: 7 days ]
    Viral load from RT-PCR test

  2. Viral clearance of SARS- CoV-2 intervention [ Time Frame: 14 days ]
    Viral load from RT-PCR test


Secondary Outcome Measures :
  1. Duration of hospitalization [ Time Frame: 28 days ]
    Day of hospitalization

  2. frequency of clinical worsening [ Time Frame: 28 days ]
    numbers of cases that have clinical worsening

  3. Mechanical ventilation [ Time Frame: 28 days ]
    numbers of cases that needs mechanical ventilation

  4. Mortality rate [ Time Frame: 28 days ]
    numbers of cases that died



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05076253


Contacts
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Contact: Thananda Trakarnvanich, M.D. 0814431628 thananda@hotmail.com
Contact: Sujaree Pupipatpab, M.D. 668818011547 sujaree@nmu.ac.th

Locations
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Thailand
Thananda Trakarnvanich Recruiting
Bangkok, Thailand, 10300
Contact: Thananda Trakarnvanich, M.D.    0814431628    thananda@hotmail.com   
Contact: Sujaree Pupipatpab, M.D.    66818011547    sujaree@nmu.ac.th   
Sponsors and Collaborators
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Investigators
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Principal Investigator: Thananda Trakarnvanich, M.D. Bangkok Metropolitan Administration and Vajira Hospital
Publications:
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Responsible Party: Thananda Trakarnvanich, Associate Professor, Bangkok Metropolitan Administration Medical College and Vajira Hospital
ClinicalTrials.gov Identifier: NCT05076253    
Other Study ID Numbers: 171/64
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available upon request after publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital:
efficacy
ivermectin
covid-19
randomised controlled trial
Additional relevant MeSH terms:
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Infections
COVID-19
Poisoning
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Chemically-Induced Disorders
Ivermectin
Antiparasitic Agents
Anti-Infective Agents