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

Phase 2

Terminated

• Conditions: Covid19
• Interventions: Drug: Placebo; Drug: Niclosamide

• Registration Number: NCT04858425
• Lead Sponsor: Entero Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-26
• Study Start: 2021-04-30
• Primary Completion: 2022-06-04
• Status Verified: 2023-06
• Study Completion: 2023-09-10
• Results First Submitted: 2024-03-21
• Results First Submitted QC: 2024-07-01
• Results First Posted: 2024-07-24
• Last Update Submitted: 2024-09-16
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

1. 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.
2. Part 2 only, patients with a primary diagnosis of COVID-19, with or without pneumonia.

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Exclusion Criteria

1. 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.
2. 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.
3. Patients who, at the time of enrollment, are not in a clinical condition compatible with the oral administration of the study drug.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo tablets 3 times daily for 14 days
Niclosamide	Niclosamide	Niclosamide tablets 400 mg 3 times daily for 14 days

Primary Outcome Measures

Name	Time	Method
SAEs	Day 1 to 6 weeks	Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA).
TEAE	Day 1 to 6 weeks	Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation.
Fecal RNA Virus Clearance	Day 1 to 6 weeks	Time to fecal viral RNA clearance (stool sample) assessed by RT-qPCR in the niclosamide arm compared to the placebo arm.
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Leukocytes and Platelets)	Day 1 to Day 43	Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided.
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Hemocrit)	Day 1 to Day 43	Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided.; Hemocrit (L/L)
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Erythrocytes)	Day 1 to Day 43	Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided.; Erythrocytes
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Bilirubin and Serum Creatinine)	Day 1 to Day 43	Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided.
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Hemoglobin)	Day 1 to Day 43	Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided.; Hemoglobin (g/L)
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically BUN, Glucose, Chloride, Potassium, and Sodium)	Day 1 to Day 43	Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided.
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Alkaline Phosphatase, AST, ALT, and LDH)	Day 1 to Day 43	Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided.
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Corpuscular Volume)	Day 1 to Day 43	Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided.; Corpuscular volume (fL)

Trial Locations

Locations (25)

Yashoda Hospital; 🇮🇳 Secunderabad, Andhra Pradesh, India

SSG Hospital and Medical Institute; 🇮🇳 Vadodara, Gujarat, India

Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council; 🇺🇦 Dnipro, Ukraine

Municipal Non-Profit Enterprise City Clinical Hospital 13 of Kharkiv Regional Council; 🇺🇦 Kharkiv, Ukraine

GMERS Medical College and Hospital; 🇮🇳 Vadodara, Gujarat, India

Communal Non-Commercial Medical Enterprise "Likarnya Prydniprovska"; 🇺🇦 Kremenchug, Poltava, Ukraine

Homestead Associates in Research; 🇺🇸 Homestead Meadows, Texas, United States

IACT Health - Roswell; 🇺🇸 Columbus, Georgia, United States

Tranquil Research; 🇺🇸 Webster, Texas, United States

SMS Clinical Research LLC; 🇺🇸 Mesquite, Texas, United States

Sir Ganga Ram Hospital; 🇮🇳 Nagar, New Delhi, India

Malla Reddy Narayana Multispecialty Hospital; 🇮🇳 Hyderabad, Telangana, India

Municipal Non-profit Enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council; 🇺🇦 Ivano-Frankivsk, Ukraine

Private Enterprise Private Manufacturing Company Acinus; 🇺🇦 Kropyvnytskyi, Ukraine

Midland Florida Clinical Research Center, LLC; 🇺🇸 DeLand, Florida, United States

Central Alabama Research; 🇺🇸 Birmingham, Alabama, 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

Snake River Research, PLLC; 🇺🇸 Idaho Falls, Idaho, United States

Noble Hospital Private Limited; 🇮🇳 Pune, Maharashtra, India

Maharaja Agrasen Superspeciality Hospital, Jaipur; 🇮🇳 Jaipur, Rajasthan, India