None listed
Conditions
Interventions
Drug : 1. Drug name
1) Study drug: DW2008S 200mg
2) Comparator: placebo of the test drug
2. Dose: 800mg (4Tb)
3. Number of times: once a day
4. Duration: 14 days (administered for at least 5 days)
Sponsors
Dongwha Pharmaceutical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male and female over the age of 19 2. Real-time reverse transcription polymerase chain reaction with specimens collected from the upper airway (oral/nasopharyngeal smear mix, etc.) or/and lower airway (sputum, etc.) within 7 days of randomization Reverse transcription polymerase chain reaction (rRT-PCR) test results, the first confirmed COVID-19 infection 3. Time of randomization COVID-19 - Those who have developed symptoms within 7 days 4. A person who corresponds to moderate COVID-19 at the time of randomization, and who meets the condition of lower respiratory tract infection and blood oxygen saturation (SpO2) = 94% in indoor air conditions by imaging or clinical findings 5. According to the eight-category ordinal scale, those who are classified as a score of 4 or 5 at the time of randomization 6. Those who are hospitalized or are expected to be admitted to a medical institution 7. A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing and fully understanding the detailed explanation of this clinical trial
Exclusion criteria
Exclusion criteria: 1. A person who shows severe COVID-19 symptoms and meets at least one of the following conditions at the time of randomization 1.1. Blood oxygen saturation (SpO2) 30 breaths/min 2. Persons with hypersensitivity to clinical investigational drugs (Justicia procumbens) 3. Patients with gastrointestinal diseases and surgeries that may affect drug absorption, distribution, metabolism, and excretion, current active gastritis, gastrointestinal/rectal bleeding, gastric ulcer, pancreatic dysfunction such as pancreatitis (except for simple appendicectomy or hernia surgery) )factor 4. Those who have received drugs such as antiviral drugs, neutralizing antibody therapy, plasma fraction therapy, and other immune modulators (cytokine therapy, etc.) for the purpose of treating COVID-19 infection within 28 days prior to screening (however, sufficient wash-out period) After this, you can participate in clinical trials) However, those who started administering drugs approved or approved for emergency use by domestic regulatory authorities as a treatment for COVID-19 within 24 hours of randomization can register, and for details, follow Section 8.3.2 of the main text. 5. Those who received any vaccinations within 14 days of randomization 6. Renal impairment (serum creatinine > 1.5 times the upper limit of organ normal) 7. Hepatic impairment (ALT or AST > 3 times the upper limit of organ normal) 8. Persons with viral diseases other than COVID-19 (HIV, HBV, HCV, etc.) that require administration of other antiviral drugs 9. Those who require mechanical ventilation (eg, non invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc.) 10. Patients with chronic underlying diseases who are unsuitable for clinical trial participation (uncontrolled diabetes, chronic kidney disease, chronic liver disease, chronic lung disease, chronic cardiovascular disease, blood cancer, chemotherapy cancer patients, patients taking immunosuppressants, etc.) 11. Pregnant women or breastfeeding mothers 12. Women and men of childbearing potential who plan to become pregnant or do not intend to use the appropriate contraceptive methods 13. A person who has participated in another clinical trial/medical device clinical trial within 28 days from the date of signing the consent form and has received/administered/treated clinical investigational drug/medical device 14. A person who has been determined that it is inappropriate to participate in this study for any other reasons by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of clinical failure subjects by 28 days after administration of the investigational drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Viral load change from baseline; COVID-19 virus negative rate (%); Proportion of subjects who improved by 2 or more steps on the clinical eight-category ordinal scale compared to baseline; The time it takes to recover to a clinically normal value after administration of the clinical trial drug;NEWS (national early warning score) change from baseline;CRP change from baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactJOONSUP YEOM
Yonsei University Health System, Severance Hospital
Outcome results
None listed