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

NCT04858425 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: AZ-NICL-COV-1
• Study Type: interventional
• Target: 166
• Locations: 3 countries
• Sites: 25

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.

Conditions

Covid19

Keywords

SARS-CoV-2; Covid; Covid19 Diarrhea; Covid19 GI Infection

Outcome Measures

Primary Outcomes (11)

• SAEs

  Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA).

  Day 1 to 6 weeks

• TEAE

  Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation.

  Day 1 to 6 weeks

• Fecal RNA Virus Clearance

  Time to fecal viral RNA clearance (stool sample) assessed by RT-qPCR in the niclosamide arm compared to the placebo arm.

  Day 1 to 6 weeks

• Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Leukocytes and Platelets)

  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.

  Day 1 to Day 43

• Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Erythrocytes)

  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

  Day 1 to Day 43

• Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Hemocrit)

  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)

  Day 1 to Day 43

• Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Hemoglobin)

  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)

  Day 1 to Day 43

• Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Corpuscular Volume)

  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)

  Day 1 to Day 43

• Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically BUN, Glucose, Chloride, Potassium, and Sodium)

  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.

  Day 1 to Day 43

• Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Alkaline Phosphatase, AST, ALT, and LDH)

  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.

  Day 1 to Day 43

• Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Bilirubin and Serum Creatinine)

  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.

  Day 1 to Day 43

Study Arms (2)

Niclosamide

EXPERIMENTAL

Niclosamide tablets 400 mg 3 times daily for 14 days

Drug: Niclosamide

Placebo

PLACEBO COMPARATOR

Matching placebo tablets 3 times daily for 14 days

Drug: Placebo

Interventions

Niclosamide DRUG

Niclosamide tablets 400 mg 3 times daily for 14 days

Niclosamide

Placebo DRUG

Matched placebo tablets 400 mg 3 times daily for 14 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Entero Therapeutics: lead

Study Sites (25)

Central Alabama Research

Birmingham, Alabama, 35209, United States

Location

Midland Florida Clinical Research Center, LLC

DeLand, Florida, 32720-0920, United States

Location

New Generation Medical Research

Hialeah, Florida, 33016-1895, United States

Location

LCC Medical Reserach Institute, LLC

Miami, Florida, 33126, United States

Location

Westchester General Hospital

Miami, Florida, 33155-2805, United States

Location

Miami Clinical Research

Miami, Florida, 33155, United States

Location

P & S Research, LLC

Miami, Florida, 33175-2912, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

IACT Health - Roswell

Columbus, Georgia, 30076, United States

Location

Snake River Research, PLLC

Idaho Falls, Idaho, 83404, United States

Location

Homestead Associates in Research

Homestead Meadows, Texas, 33032-8225, United States

Location

SMS Clinical Research LLC

Mesquite, Texas, 75149, United States

Location

Tranquil Research

Webster, Texas, 77598, United States

Location

Yashoda Hospital

Secunderabad, Andhra Pradesh, 50003, India

Location

SSG Hospital and Medical Institute

Vadodara, Gujarat, 390001, India

Location

GMERS Medical College and Hospital

Vadodara, Gujarat, 390021, India

Location

Noble Hospital Private Limited

Pune, Maharashtra, 411013, India

Location

Sir Ganga Ram Hospital

Nagar, New Delhi, 110060, India

Location

Maharaja Agrasen Superspeciality Hospital, Jaipur

Jaipur, Rajasthan, 302039, India

Location

Malla Reddy Narayana Multispecialty Hospital

Hyderabad, Telangana, 500055, India

Location

Communal Non-Commercial Medical Enterprise "Likarnya Prydniprovska"

Kremenchuk, Poltava Oblast, 39600, Ukraine

Location

Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council

Dnipro, 41102, Ukraine

Location

Municipal Non-profit Enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council

Ivano-Frankivsk, 76025, Ukraine

Location

Municipal Non-Profit Enterprise City Clinical Hospital 13 of Kharkiv Regional Council

Kharkiv, 61124, Ukraine

Location

Private Enterprise Private Manufacturing Company Acinus

Kropyvnytskyi, 25006, Ukraine

Location

MeSH Terms

Conditions

COVID-19

Interventions

Niclosamide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Salicylanilides; Anilides; Amides; Organic Chemicals; Salicylamides; Aniline Compounds; Amines

Results Point of Contact

• Title: VP, Regulatory, QA & Compliance
• Organization: First Wave BioPharma

AChandler@FirstWaveBio.com

19194491484

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: April 30, 2021
• Primary Completion: June 4, 2022
• Study Completion: September 10, 2023
• Last Updated: October 8, 2024
• Results First Posted: July 24, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (13); UA (5); IN (7)