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
Drug: Niclosamide Oral Tablet
Niclosamide tablets 400 mg 3 times daily for 14 days
Drug: Placebo
Matching placebo tablets 3 times daily for 14 days
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.