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Nitazoxanide for post-exposure prophylaxis of COVID-19 in elderly LTCF residents
NCT04343248Phase 3
Key facts
- Status
- Terminated
- Start
- May 2020
- Primary completion
- Feb 2021
- Countries
- 1
- Sponsor
- Romark Laboratories
- Modality
- Small Molecules
- Drugs
- nitazoxanide
- Conditions
- coronavirus disease 2019 (COVID-19)viral respiratory infection
01
Overview
Phase 3, randomised, double-blind trial in coronavirus disease 2019 (COVID-19) and viral respiratory infection comparing Nitazoxanide with Placebo (2 arms). Primary endpoints: Symptomatic Laboratory-confirmed COVID-19 at 6 weeks and Symptomatic Laboratory-confirmed Viral Respiratory Illness at 6 weeks. Started May 2020; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Nitazoxanide
Nitazoxanide 600 mg (2 x 300 mg) BID
Placebo
Placebo BID
03
Who it enrols
Elderly residents (>=55 years) of Long-Term Care Facilities with at least one confirmed COVID-19 case in the facility within 10 days. Excludes those with prior COVID-19, inability to swallow, or taking CYP2C8 substrates.
04
Endpoints
Primary
Symptomatic Laboratory-confirmed COVID-19
Symptomatic Laboratory-confirmed Viral Respiratory Illness
Secondary
Hospitalization Due to COVID-19 or Complications
Mortality Due to COVID-19 or Complications
Presence of Anti-SARS-CoV-2 Antibodies
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