A Phase 1 Study of Ivermectin in Healthy Volunteers [COVID-19]

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Exploratory Phase I Trial Assessing the Pharmacokinetic Profile, Safety and Tolerability of a Continuous Daily Dosing Regimen of Ivermectin in Healthy Volunteers

• IRAS ID

  287568

• Contact name

  Pui Man Leung

• Sponsor organisation

  MedinCell S.A.

• Eudract number

  2020-002975-36

• Duration of Study in the UK

  0 years, 3 months, 31 days

• Research summary

  The purpose of this study is to test a drug called ivermectin, that is being developed as a treatment to prevent infection with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), which causes COVID-19.

  COVID-19 is a highly contagious disease, caused by a virus, SARS-CoV-2. After an initial outbreak in Wuhan, China at the end of 2019, it became a pandemic. The exact mechanisms of how the virus infects and replicates in humans are not yet clearly established. Most patients with COVID-19 develop mild or uncomplicated illness, but approximately 20-30% of hospitalised patients have required intensive care support and 5% of those experience multi-organ failure or shock (lack of blood flow). Treatments for COVID-19 in high risk individuals remain experimental.
  Ivermectin is a well-established treatment for several parasitic infections.

  Ivermectin has shown the ability to stop the virus causing COVID-19 from using human cells to replicate, in laboratory tests. Ivermectin is only given for one or two days as a treatment for parasitic infections. This study will test giving the drug for 28 consecutive days at several different strengths.

  The aims of this study are:
  - Characterise the pharmacokinetic (PK) profile of ivermectin following daily repeated doses for 28 days.
  - Characterise the safety and tolerability profile of daily repeated dosing of ivermectin for 28 days.
  - Evaluate the potential of ivermectin as a prophylactic measure to SARS-CoV-2 infection.

  24 healthy male volunteers will be enrolled between 18 to 45 years. There will be 3 groups of 8 participating for approximately 10 weeks. Consisting of screening, a residential period (Day -1 until Day 7), outpatient visits on Day 14, Day 21, and another inpatient visit (Day 28 to Day 29). Follow-up visits on Day 32, Day 35 and Day 42. Visits will take place at the MAC Clinical Research Unit, in Manchester.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  20/SC/0347

• Date of REC Opinion

  18 Sep 2020

• REC opinion

  Further Information Favourable Opinion