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Nitazoxanide Prophylaxis for COVID-19 in Healthcare Workers
NCT04359680Phase 3
Key facts
- Status
- Completed
- Start
- May 2020
- Primary completion
- Apr 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: Proportion of Subjects With Symptomatic Laboratory-confirmed COVID-19 up to 6 weeks and Proportion of Subjects With Symptomatic Laboratory-confirmed Viral Respiratory Illnesses (VRI) up to 6 weeks. Started May 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Nitazoxanide
Nitazoxanide 600 mg BID + Vitamin B-Complex
Placebo
Placebo BID + Vitamin B-Complex
03
Who it enrols
Adults at increased risk of contracting COVID-19 (healthcare workers or those with frequent social interaction) without current infection or history of COVID-19.
04
Endpoints
Primary
Proportion of Subjects With Symptomatic Laboratory-confirmed COVID-19
Proportion of Subjects With Symptomatic Laboratory-confirmed Viral Respiratory Illnesses (VRI)
Secondary
Proportion Experiencing Mortality Due to COVID-19 or Complications Thereof
Proportion With Anti-SARS-CoV-2 Antibodies
05
Results
Not all primary endpoints met
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