Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Covid19

In brief

This is a 2-part, 2-arm, Phase 2 , multicentre, randomized, double-blind, placebo-controlled study in adults with COVID-19 with gastrointestinal infection.

Key facts

Study ID

NCT04858425

Run by

Entero Therapeutics

People needed

166

Starts

2021-04-30

Expected to finish

2023-09-10

Last updated by the study team

2024-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Part 1 only, patients with a primary diagnosis of COVID-19, with or without pneumonia, who agree to be monitored daily for at least 7 days after randomization and who accept continuing to be assessed for the study procedures.
• Part 2 only, patients with a primary diagnosis of COVID-19, with or without pneumonia.

You may not qualify if…

• At the time of randomization, patients who require intensive care unit (ICU) admission or patients with severe respiratory insufficiency who require mechanical ventilation or with rapid worsening of respiratory function leading to expectation for mechanical ventilation or ICU admission.
• Evidence of rapid clinical deterioration or existence of any life-threatening co-morbidity or any other medical condition that, in the opinion of the investigator, makes the patient unsuitable for inclusion.
• Patients who, at the time of enrollment, are not in a clinical condition compatible with the oral administration of the study drug.

Where it is running

• Central Alabama Research — Birmingham, Alabama, United States
• Midland Florida Clinical Research Center, LLC — DeLand, Florida, United States
• New Generation Medical Research — Hialeah, Florida, United States
• LCC Medical Reserach Institute, LLC — Miami, Florida, United States
• Westchester General Hospital — Miami, Florida, United States
• Miami Clinical Research — Miami, Florida, United States
• P & S Research, LLC — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• IACT Health - Roswell — Columbus, Georgia, United States
• Snake River Research, PLLC — Idaho Falls, Idaho, United States
• Homestead Associates in Research — Homestead Meadows, Texas, United States
• SMS Clinical Research LLC — Mesquite, Texas, United States
• Tranquil Research — Webster, Texas, United States
• Yashoda Hospital — Secunderabad, Andhra Pradesh, India
• SSG Hospital and Medical Institute — Vadodara, Gujarat, India
• GMERS Medical College and Hospital — Vadodara, Gujarat, India
• Noble Hospital Private Limited — Pune, Maharashtra, India
• Sir Ganga Ram Hospital — Nagar, New Delhi, India
• Maharaja Agrasen Superspeciality Hospital, Jaipur — Jaipur, Rajasthan, India
• Malla Reddy Narayana Multispecialty Hospital — Hyderabad, Telangana, India
• Communal Non-Commercial Medical Enterprise "Likarnya Prydniprovska" — Kremenchuk, Poltava Oblast, Ukraine
• Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council — Dnipro, Ukraine
• Municipal Non-profit Enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council — Ivano-Frankivsk, Ukraine
• Municipal Non-Profit Enterprise City Clinical Hospital 13 of Kharkiv Regional Council — Kharkiv, Ukraine
• Private Enterprise Private Manufacturing Company Acinus — Kropyvnytskyi, Ukraine

Full record on ClinicalTrials.gov

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