COVID-19 trials registries data warehouse

https://cris.nih.go.kr/cris/search/detailSearchEn.do?seq=21932

Chang min Sung

mdscm@bestian.kr

2022-05-19

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

1) A subject who voluntarily decides to participate this clinical study after hearing the detailed explanation of this clinical trial and agrees in writing to abide by the precautions 2) Adults over 19 years of age at the time of screening 3) Those who are confirmed to be infected with COVID-19 by RT-PCR test within 3 days from the date of randomization 4) Those who have developed one or more of the symptoms of COVID-19* within 5 days from the date of randomization, and have at least two or more symptoms of 2 or higher among the symptom scores** determined on the day of randomization * Coronavirus Infectious Disease-19 Symptoms: Fever (above 38.0?), cough, sore throat, headache, muscle pain, chills/tremor, runny nose/stuffy nose, sputum, fatigue/malarity, shortness of breath/shortness of breath, nausea/nausea, vomiting, diarrhea ** Symptoms are evaluated in a total of 4 stages: 0=(absent), 1=(mild), 2=(moderate), 3=(severe). 5) Those who are mild or moderate according to the NIH triage criteria at screening and randomization.

1) If one or more of the following severe findings were shown at the time of screening - Oxygen saturation (SpO2) less than 94% in indoor air conditions - Respiratory rate greater than 30 breaths per minute - PaO2/FiO2 < 300 mmHg - Lung infiltration >50% on chest imaging 2) Subjects who require oxygen therapy (Supplemental oxygen, Non-invasive ventilation, invasive ventilation, extracorporeal membrane oxygenation, etc.) or have serious conditions such as respiratory failure, shock, or multiple organ failure 3) Those who have hypersensitivity to the main ingredient (niclosamide) and components of the clinical investigational drug 4) Subjects with genetic problems such as lactose intolerance, galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption 5) Subjects with renal impairment (eGFR < 30 mL/min/1.73 m2) 6) Subjects with hepatic impairment (ALT or AST > 5 times the upper limit of normal organ) 7) Cirrhosis Subjects with a Child-Pugh score of B or C A B C Ascites None Easily controlled Poorly controlled Bilirubin < 2 mg/dL 2~3 mg/dL > 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 with gastrointestinal diseases and 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 coronavirus infection-19 infection within 28 days of the screening test. However, after a sufficient withdrawal period of the drug has elapsed, it is possible to participate in the clinical trial. 10) If you have one or more of the following infectious diseases in the past or present - Viral diseases other than COVID-19 (HIV, HBV, HCV, etc.) that require administration of other antiviral drugs - Serious infections that require systemic anti-infective treatment other than COVID-19 infection within 30 days before administration of the investigational drug 11) Pregnant or lactating women 12) Women and men of childbearing potential who plan to become pregnant or do not intend to use the appropriate contraception* *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) Those who have participated in other clinical trials/medical device clinical trials within 28 days from the date of signing the consent form and have received/administered/treated clinical investigational drugs/medical devices 14) Those who have chronic underlying diseases that are unsuitable for participation in the clinical trial as judged by the investigator, and those who are judged inappropriate for the investigator to participate in this clinical trial for other reasons

3

Hyundai Bioscience

19

100

Democratic People's Republic of Korea

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

300

The period(days) taken for the clinical improvement and clinical improvement symptoms has maintained for at least 48 hours;Adverse reaction;Vital signs (blood pressure; heart rate; respiration rate; body temperature; oxygen saturation);Clinical laboratory test;chest imaging test;ECG

Phase 2

[{"arm_notes": "900mg/day", "treatment_id": 883, "treatment_name": "Niclosamide", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "1350 mg/day", "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"}]