NCT05076253

Efficacy of Ivermectin in COVID-19

Completed Phase 1, PHASE2 Last updated 15 December 2021

What this trial tests

Phase 1, PHASE2 trial testing Ivermectin in Safety in 72 participants. Completed in 1 December 2021.

Timeline

1 September 2021

Primary endpoint
1 December 2021

1 December 2021

Quick facts

Lead sponsor	Bangkok Metropolitan Administration Medical College and Vajira Hospital
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	triple
Primary purpose	treatment
Enrollment	72
Start date	1 September 2021
Primary completion	1 December 2021
Estimated completion	1 December 2021
Sites	1 location across Thailand

Drugs / interventions tested

• Ivermectin (ivermectin) — full drug profile →
• Placebo

Conditions studied

• Safety — all drugs for Safety →
• SARS-CoV2 Infection — all drugs for SARS-CoV2 Infection →
• Ivermectin Poisoning — all drugs for Ivermectin Poisoning →
• Effect of Drug — all drugs for Effect of Drug →

Sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Who can join

Adults 18 to 80, any sex, with Safety or SARS-CoV2 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ivermectin for preventing and treating COVID-19.
   Popp M, Reis S, Schießer S, Hausinger RI, et al · · 2022 · cited 30× · PMID 35726131 · DOI 10.1002/14651858.cd015017.pub3
2. Efficacy and safety of ivermectin in the treatment of mild to moderate COVID-19 infection: a randomized, double-blind, placebo-controlled trial.
   Manomaipiboon A, Pholtawornkulchai K, Poopipatpab S, Suraamornkul S, et al · · 2022 · cited 7× · PMID 36028897 · DOI 10.1186/s13063-022-06649-3