COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04603924

Andrew Bartynski

andrew@neurobopharma.com

2020-10-27

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

key inclusion criteria: provide written informed consent prior to performing study procedures hospitalized. male or female ≥18 years of age positive for severe acute respiratory syndrome coronavirus 2 presence of symptoms of lower respiratory tract infection (lrti) including at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, or more significant lower respiratory tract symptoms, including shortness of breath at least 1 of the following: respiratory rate (rr) ≥20 breaths per minute, room air oxygen saturation (spo2) <98%, requirement for supplemental oxygen, heart rate (hr) ≥90 beats per minute, or temperature >38.3°c women of childbearing potential must agree to abstinent or use at least 1 form of contraception not including hormonal contraception from the day of screening through day 30 key

hospitalized but no longer requires ongoing inpatient care (i.e., discharge is anticipated in ≤24 hours) patient is not anticipated to survive >48 hours or is under palliative care evidence of critical illness, defined by at least 1 of the following: respiratory failure requiring at least 1 of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula noninvasive positive pressure ventilation (nipvv), or extracorporeal membrane oxygenation (ecmo) or clinical diagnosis of respiratory failure shock (defined by systolic blood pressure (bp) <90 mm hg, or diastolic blood pressure (bp) <60 mm hg or requiring vasopressors), or multi-organ dysfunction/failure severe central nervous system (cns) conditions chronic kidney disease requiring dialysis known allergy to the study drug or salicylate containing medications. suspected and/or confirmed pregnancy or breastfeeding current or planned participation in any other clinical trial of a treatment being developed under a us investigational new drug (ind) or emergency use authorization (eua). patients receiving chemotherapeutic agents and/or immunomodulators (including monoclonal antibodies (mabs) or plasma transfusions) for chronic disease conditions.

2

NeuroBo Pharmaceuticals Inc.

18

100

United States

Moderate disease at enrollment

3: Moderate disease at enrollment

436

Efficacy as measured by median time to hospital discharge (Part 2);Safety and Tolerability of ANA001 as measured by the incidence of treatment emergent adverse events (TEAE's) (Part 1 and Part 2)

None

Phase 2/Phase 3

[{"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"}]