None listed
Conditions
Interventions
Drug : The investigational product for this study is CP-COV03-T (Niclosamide 50 mg, Hyundai Bioscience Co., Ltd.) and the reference drug and CP-COV03-R (Niclosamide 50 mg placebo, Hyundai Bioscience C
Sponsors
Hyundai Bioscience
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who voluntarily determine to participate in this study after listening the detailed information and consent in writing (electronically) to comply with the study requirements. 2) Adults aged 19 and over at the time of screening 3) Subjects who are confirmed to have COVID-19 through RT-PCR test or rapid antigen kit test by a specialist within 3 days of randomization 4) Subjects who have developed one or more of the symptoms of COVID-19* within 5 days of randomization, and have at least two symptoms of 2 or higher among the symptom scores** determined on the day of randomization * Symptoms of COVID-19: Fever (38.0? or above), cough, sore throat, headache, muscle pain, chills/tremor, runny nose/stuffy nose, fatigue/malaise, dyspnea/shortness of breath, sickness/nausea, vomiting, diarrhea ** Symptoms are assessed based on a total of 4 levels: 0=(absent), 1=(mild), 2=(moderate), 3=(severe). 5) Subjects who are diagnosed as mild or moderate according to the NIH triage criteria at screening and randomization.
Exclusion criteria
Exclusion criteria: 1) Subjects who have one or more of the following severe findings at screening: - Oxygen saturation (SpO2) less than 94% in indoor air conditions - Respiratory rate greater than 30 breaths per minute - PaO2/FiO2 50% on chest imaging 2) Subjects who require oxygen therapy (e.g., supplemental oxygen, Non-invasive ventilation, invasive ventilation, extracorporeal membrane oxygenation, etc.) or have serious conditions such as respiratory failure, shock, or multiple organ failure, etc. 3) Subjects who have hypersensitivity to the main active ingredient (niclosamide) and components of the clinical investigational drug 4) Subjects who have genetic problems such as lactose intolerance, galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption 5) Subjects with renal impairment (eGFR 5 times the upper limit of normal organ) 7) Cirrhosis patients with a Child-Pugh score of B or C A B C Ascites None Easily controlled Poorly controlled Bilirubin 3 mg/dL Albumin > 3.5 g/dL 3.0~3.5 g/dL < 3.0 g/dL Encephalopathy None Mild Advanced Nutritional status Excellent Good Poor 8) Subjects who have gastrointestinal disorders or undergone surgeries that may affect drug absorption, distribution, metabolism, and excretion (except for simple appendicectomy or hernia surgery) 9) Those who have received drugs such as antiviral agents, neutralizing antibody therapy, plasma fraction therapy, and immune modulators (cytokine therapy, etc.) for the treatment of COVID-19 infection within 28 days of the screening test. However, after a sufficient drug-free interval, the patient may be eligible for participating in the study 10) Subjects who have or had one or more of the following infectious diseases: - Viral diseases other than COVID-19 that require administration of other antiviral drugs (HIV, HBV, HCV, etc.) - Serious infections that require ystemic anti-infective treatment other than COVID-19 infection within 30 days before administration of the investigational drug 11) Pregnant or lactating women 12) Fertile women and men who plan to become pregnant or do not intend to use the following appropriate contraceptive methods* during the clinical study and for 3 months after the study termination. *hormonal contraception, intrauterine device, double blocking method (both male (condom) and female (contraceptive diaphragm, vaginal sponge or cervical cap) use), sterilization (vasectomy, tubal ligation, etc.) 13) Subjects who have participated in other clinical trials of a drug/medical device within 28 days of the consent form sign date and have administered/treated with that clinical investigational drugs/medical devices 14) Subjects who have chronic underlying diseases that are unsuitable for participation in the study in the opinion of the investigator, and who are determined by the investigator to be inappropriate to participate in this clinical study for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time(days) taken for the symptoms of COVID-19 to improve and continue for more than 48 hours by Day 14;Adverse event;Vital signs (blood pressure, heart rate, respiration rate, body temperature, oxygen saturation);Clinical laboratory test;chest imaging test;Electrocardiogram(ECG) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic characteristics of niclosamide and correlation between pharmacokinetic parameters and viral load;Time (days) taken for each COVID-19 symptom to improve and continue for more than 48 hours by Day 14;Time (days) taken for each COVID-19 symptom to improve by Day 14;Time (days) taken for the score of each COVID-19 symptom to decrease by 1 point or more by Day 14;Changes in the total score and mean of all COVID-19 symptoms by Day 14 (asymptomatic items are excluded from the mean calculation);Time(days) taken for the total score of COVID-19 symptoms to decrease by 25% or more and 50% or more by Day 14;Presence and number of the appearance of new symptoms derived from COVID-19 other than pre-defined symptoms by Day 14;Changes in SARS-CoV-2 viral load for Day 2, Day 4, Day 6 and Day 8 compared to before administration of the investigational product;Among the rescue medications used on Day 1 to Day 28, the dose and dosing frequency of Acetaminophen, Ibuprofen, and antidiarrheal drugs;Proportion of subjects who worsened to severe level or worse from Day 1 to Day 28 | — |
Countries
Korea, Republic of
Contacts
Public ContactDukju Moon
Bestian Hospital
Outcome results
None listed