COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04542434

Tony Opipari, M.D.

tony@firstwavebio.com

2020-09-09

Withdrawn

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

- 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

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

0

Heart rate;Safety laboratory;Blood pressure;fecal RNA virus clearance;Body temperature;TEAE;SAEs;Mortality;ECG;SaO2

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"}]