COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04858425

Ansy Mathews

amathews@firstwavebio.com

2021-04-26

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: part 1 only, patients with a primary diagnosis of covid-19, with or without pneumonia, who agree to be monitored daily for at least 7 days after randomization and who accept continuing to be assessed for the study procedures. part 2 only, patients with a primary diagnosis of covid-19, with or without pneumonia.

at the time of randomization, patients who require intensive care unit (icu) admission or patients with severe respiratory insufficiency who require 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 that, in the opinion of the investigator, makes the patient unsuitable for inclusion. patients who, at the time of enrollment, are not in a clinical condition compatible with the oral administration of the study drug.

2

First Wave BioPharma, Inc.

18

100

India;Ukraine;United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

166

Fecal RNA virus Clearance;SAEs;Safety Laboratory Tests including CBC, BUN, blood sugar, electrolytes;TEAE

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"}]