Efficacy of Ivermectin in COVID-19
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|ClinicalTrials.gov Identifier: NCT05076253|
Recruitment Status : Completed
First Posted : October 13, 2021
Last Update Posted : December 15, 2021
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|
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 (Clinical Trial)|
|Actual Enrollment :||72 participants|
|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|
|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|
|Actual Primary Completion Date :||December 1, 2021|
|Actual Study Completion Date :||December 1, 2021|
Active Comparator: Ivermectin
Ivermectin 12 mg per day for 5 plus standard care
Ivermectin plus standard care
Placebo Comparator: Placebo
Placebo plus standard care
Ivermectin plus standard care
- Viral clearance of SARS- CoV-2 intervention [ Time Frame: 7 days ]Viral load from RT-PCR test
- Viral clearance of SARS- CoV-2 intervention [ Time Frame: 14 days ]Viral load from RT-PCR test
- Duration of hospitalization [ Time Frame: 28 days ]Day of hospitalization
- frequency of clinical worsening [ Time Frame: 28 days ]numbers of cases that have clinical worsening
- Mechanical ventilation [ Time Frame: 28 days ]numbers of cases that needs mechanical ventilation
- Mortality rate [ Time Frame: 28 days ]numbers of cases that died
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
|Bangkok, Thailand, 10300|
|Principal Investigator:||Thananda Trakarnvanich, M.D.||Bangkok Metropolitan Administration and Vajira Hospital|