COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04436458

Tony Opipari, M.D.

tony@firstwavebio.com

2020-06-18

Withdrawn

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - patients hospitalized for treatment 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. - patients who prior to developing covid-19 usually have normal bowel habits defined as at least 3 stools per week and no more than 3 stools per day. - sars-cov-2 infection confirmed by rt-pcr 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.

2

First Wave BioPharma, Inc.

18

100

None

Moderate disease at enrollment

3: Moderate disease at enrollment

0

The primary endpoint is the rate of faecal SARS-CoV-2 virus clearance (rectal swab or stool sample) assessed by RT-PCR in the niclosamide group, compared to the placebo group

None

Phase 2

[{"arm_notes": "", "treatment_id": 883, "treatment_name": "Niclosamide", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]