CompletedPhase 2/3

Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients

United States49 participantsStarted 2020-10-07

Plain-language summary

Study of ANA001 in Moderate and Severe COVID-19 Patients

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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:
✕. 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
✕. Severe central nervous system (CNS) conditions
✕. Chronic kidney disease requiring dialysis

Number of Subjects Experiencing TEAEs

Timeframe: Randomization to Day 60

Number of Subjects Experiencing TESAEs

Timeframe: Randomization to Day 60

NCT IDNCT04603924

SponsorNeuroBo Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-16

Results submitted2024-08-06

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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:
✕. 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
✕. Severe central nervous system (CNS) conditions
✕. Chronic kidney disease requiring dialysis