Dompe' Reparixin study

A multinational, multicentre, randomised, doubleblinded, placebo-controlled, parallel-group phase III trial Reparixin 1200 mg three times a day as add-on therapy to standard of care to limit disease progression in hospitalised adult patients with COVID-19.

medical-cross
COVID-19
user
All genders
person-wave 18+
world
Recruiting now
More information  

Overview
Principal Investigator: Brian Chow, MD

This is a research study being conducted in patients who tested positive for COVID-19 in the past 10 days and are admitted to the hospital. The study is being conducted to assess the safety of an experimental drug called Reparixin. This is provided as tablets along with standard treatment to limit progression of Covid-19 disease. This is a randomized, (which means just like tossing a coin, you will be randomly assigned to receive the study drug or the standard treatment) double-blind trial (which means neither you nor the study team will know which group you are assigned to). Details of the study visits are as noted below.

Contact Us

user
Rupali Ranade

Study details
Inclusion Criteria
  • Adults ≥18 years old
  • Hospitalized confirmed Covid-19 patients.
  • Receiving oxygen by mask or nasal cannula
Exclusion Criteria
  • Subjects with liver or/and kidney diseases.
  • Pregnant or lactating women
  • Anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening
Study Requirements

There are up to a total of 7 study visits with a follow up phone call for Visit 8. All study visits will be conducted while you are in the hospital. The number of total visits depends on the duration of hospital admission.

The main study procedures are:

  1. Blood draws at screening, days 1, 3, 7, 14, 21 and 28 or at discharge. Total amount of blood collected at each visit is about 10ml( less than 1 tablespoon). In addition, about 10ml blood collected at first visit and end of the treatment. Total amount would be about 80-90ml ( 5-6 tablespoons) for the study.
  2. The study involves intake of study drug/placebo, monitoring of vital signs, ECG and in some cases, chest X-ray or CT scan if not done for clinical care.
  3. Pregnancy test (urine dipstick) will be performed in women of childbearing potential. Positive urine test results will be confirmed with a blood pregnancy test; Pregnancy test will be repeated at end of treatment.
  4. 60-day follow-up by phone.