Clinical trial NCT04858425: Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection
Official title: A 2-Part, 2-Arm, Phase 2, Randomized, Double-Blind, Placebo-Controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Keywords: SARS-CoV-2
Covid
Covid19 Diarrhea
Covid19 GI Infection
Lead sponsor: Entero Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-04-26
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: SAEs
timeFrame: Day 1 to 6 weeks
measure: TEAE
timeFrame: Day 1 to 6 weeks
measure: Fecal RNA Virus Clearance
timeFrame: Day 1 to 6 weeks
measure: Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Leukocytes and Platelets)
timeFrame: Day 1 to Day 43
measure: Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Erythrocytes)
timeFrame: Day 1 to Day 43
measure: Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Hemocrit)
timeFrame: Day 1 to Day 43
measure: Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Hemoglobin)
timeFrame: Day 1 to Day 43
measure: Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Corpuscular Volume)
timeFrame: Day 1 to Day 43
measure: Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically BUN, Glucose, Chloride, Potassium, and Sodium)
timeFrame: Day 1 to Day 43
measure: Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Alkaline Phosphatase, AST, ALT, and LDH)
timeFrame: Day 1 to Day 43
measure: Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Bilirubin and Serum Creatinine)
timeFrame: Day 1 to Day 43
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Alabama Research
state: Alabama
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center, LLC
state: Florida
city: Hialeah
country: United States
facility: New Generation Medical Research
state: Florida
city: Miami
country: United States
facility: LCC Medical Reserach Institute, LLC
state: Florida
city: Miami
country: United States
facility: Westchester General Hospital
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: Miami
country: United States
facility: P & S Research, LLC
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Columbus
country: United States
facility: IACT Health - Roswell
state: Georgia
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC
state: Idaho
city: Homestead Meadows
country: United States
facility: Homestead Associates in Research
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research LLC
state: Texas
city: Webster
country: United States
facility: Tranquil Research
state: Texas
city: Secunderabad
country: India
facility: Yashoda Hospital
state: Andhra Pradesh
city: Vadodara
country: India
facility: SSG Hospital and Medical Institute
state: Gujarat
city: Vadodara
country: India
facility: GMERS Medical College and Hospital
state: Gujarat
city: Pune
country: India
facility: Noble Hospital Private Limited
state: Maharashtra
city: Nagar
country: India
facility: Sir Ganga Ram Hospital
state: New Delhi
city: Jaipur
country: India
facility: Maharaja Agrasen Superspeciality Hospital, Jaipur
state: Rajasthan
city: Hyderabad
country: India
facility: Malla Reddy Narayana Multispecialty Hospital
state: Telangana
city: Kremenchug
country: Ukraine
facility: Communal Non-Commercial Medical Enterprise "Likarnya Prydniprovska"
state: Poltava
city: Dnipro
country: Ukraine
facility: Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council
city: Ivano-Frankivsk
country: Ukraine
facility: Municipal Non-profit Enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council
city: Kharkiv
country: Ukraine
facility: Municipal Non-Profit Enterprise City Clinical Hospital 13 of Kharkiv Regional Council
city: Kropyvnytskyi
country: Ukraine
facility: Private Enterprise Private Manufacturing Company Acinus
Study officials:
References: