Niclosamide in COVID-19
- Registration Number
- NCT04542434
- Lead Sponsor
- Entero Therapeutics
- Brief Summary
This is a two-part, Phase 2, multicentre, randomized, double blind, 2-arm placebo-controlled study in adults with moderate COVID-19 with gastrointestinal signs and symptoms
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Part 1 only: Patients hospitalized with a primary diagnosis of COVID-19 with or without pneumonia, who are expected to remain in hospital at least seven days after the randomization and who accept continuing to be assessed for the study procedures (home or outpatient unit) up to 6 weeks in case of discharge.
Part 2 only: Patients with a primary diagnosis of COVID-19 with or without pneumonia who are not planned to be hospitalized.
- Patients who prior to developing COVID-19 usually have normal bowel habits defined as at least solid-formed 3 stools per week and no more than 3 solid-formed stools per day.
- SARS-CoV-2 RNA presence in rectal swab (or stool test) ≤2 days before randomization by local or central lab.
- Diarrhea defined as at least 3 watery stools in the last 24 hours prior to enrolment
- At the time of randomization patients requiring ICU admission or patients with severe respiratory insufficiency requiring 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 which, in the opinion of the investigator, makes the patient unsuitable for inclusion.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Niclosamide Niclosamide Oral Tablet -
- Primary Outcome Measures
Name Time Method SAEs From Day 1 to end of study Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA)
TEAE From Day 1 to 6 weeks Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation
Mortality From Day 1 to 6 weeks All-cause mortality
Body temperature From Day 1 to 6 weeks Change in body temperature from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
SaO2 From Day 1 to 6 weeks Change in SaO2 from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
Safety laboratory From Day 1 to 6 weeks Change in safety laboratory tests 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
Blood pressure From Day 1 to 6 weeks Change in sitting systolic and diastolic blood pressure from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
ECG From Day 1 to 6 weeks Change in ECG parameters including: 1. PR interval 2. RR interval 3. QRS interval 4 QT interval 5. HR interval 6. QtcF interval. All intervals summarized descriptively by visit from baseline to 6 weeks
fecal RNA virus clearance From Day 1 to 6 weeks time to fecal RNA virus clearance (rectal swab or stool sample) assessed by RT-qPCR in the niclosamide group, compared to the placebo group (Part 2 only)
Heart rate From Day 1 to 6 weeks Change in heart rate from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
- Secondary Outcome Measures
Name Time Method