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NIC for COVID-19


Title Niclosamide for Patients with Mild to Moderate Disease from Novel Coronavirus (COVID-19)
Therapeutic Area Covid-19
Principal Investigator Harry Selker, MD
Min Age 18 Years
Gender All
Contact Dorothy Dulko, PhD, CCRP
617-636-5367
covidresearch@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04399356

Overview

Participation in this study can be done remotely, from your home. No in-person interactions with the researchers will be needed, and no travel will be required.

To be eligible, contact with the study team needs to be made within 3 days of the time you were tested for COVID-19.

 

What is the purpose of the study? Coronavirus disease 2019 (COVID-19) is a public health emergency for which there is no known effective treatment. This study will evaluate the study drug, Niclosamide, as a potential treatment for mild to moderate COVID-19 to find out if it is effective in shortening the time that COVID-19 is contagious. This research study will also evaluate if Niclosamide works to shorten the time of symptoms related to COVID-19.

Background: Niclosamide has been widely used in humans to treat tapeworm infections for several decades and is currently listed on the World Health Organization’s List of Essential Medicines, the safest and most effective medicines needed in a health system.

Study Details

Inclusion Criteria

  • Mild or moderate cases- defined based on less severe clinical symptoms (fever, cough, discomfort).  Patients with a positive COVID -19 test without symptoms will also be included.  
  • No need for oxygen supplementation
  • Not requiring hospital admission

Exclusion Criteria

  • Mild or moderate cases- defined based on less severe clinical symptoms (fever, cough, discomfort).  Patients with a positive COVID -19 test without symptoms will also be included.  
  • No need for oxygen supplementation
  • Not requiring hospital admission

Study Requirements

If you have had a positive COVID-19 test in the past 3 days, you may be eligible for this study.

Study participants will be given either niclosamide or a placebo (an inactive substance made to look like an active drug). These will be given in addition to your routine medications. In addition:

  • For safety and convenience, social distancing will be maintained by having all communication with the researchers done via a telehealth platform. There will be no face-to-face visits with the research team.
  • All study materials, including the study drug or placebo, will be delivered directly to you.
  • You will be provided a home thermometer and a fingertip oximeter (a small measurement device that goes on your fingertip to check your oxygen level), with the specific instructions to monitor your temperature and oxygen level at the same time you take your study drug/placebo each day (7 days).
  • We expect that you will be in this research study for approximately 14 days. The researchers will aslo follow up with you by phone at day 21 and day 30.

The researchers welcome the opportunity to discuss this study with you.