A randomized, double-blind, placebo-controlled design phase 2 clinical trial to comparatively evaluate the efficacy and safety of CP-COV03 in patients with mild or moderate COVID-19

Not Applicable

Completed

• Conditions: Codes for special purposes

• Registration Number: KCT0007307
• Lead Sponsor: Hyundai Bioscience

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-23
• Last Update Posted: 30 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

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

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 < 300 mmHg (Test can be omitted if it is medically unnecessary, when considering oxygen saturation, respiratory rate, etc.)
- Lung infiltrates >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 < 30 mL/min/1.73 m2)
6) Subjects with hepatic impairment (ALT or AST > 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 < 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 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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified