Covid19
Conditions
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
Interventions
Niclosamide tablets 400 mg 3 times daily for 14 days
DRUGPlacebo
Matching placebo tablets 3 times daily for 14 days
Sponsors
Entero Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | From Day 1 to 6 weeks | All-cause mortality |
| TEAE | From Day 1 to 6 weeks | Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation |
| 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) |
| 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 |
| 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) |
| 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 |
| 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 |
| SaO2 | From Day 1 to 6 weeks | Change in SaO2 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 |
Outcome results
None listed