None listed
Conditions
Interventions
Drug : Subjects participating in this clinical trial will receive the investigational product for a minimum of 3 days and up to a maximum of 7 days starting from the first administration. The investig
Sponsors
Koera University Guro Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: This clinical trial targets adult patients with mild to moderate COVID-19 who meet the following criteria: 1.Male and female participants who are at least 19 years old at the time of providing written informed consent for participation. 2. Individuals confirmed positive for SARS-CoV-2 within 72 hours prior to randomization, verified by a reverse transcription polymerase chain reaction (RT-PCR) test. 3. Mild: Participants showing symptoms associated with coronavirus infection but without dyspnea (shortness of breath) and with no abnormalities on chest radiography. Moderate: Participants with respiratory disease findings upon clinical assessment or imaging (e.g., chest radiography) who meet the following criteria without severe findings: Oxygen saturation (SpO2) of at least 94% on room air. Respiratory rate of 30 breaths per minute or less. 4. Participants must have experienced the onset of at least one symptom related to coronavirus infection (e.g., fever, cough, shortness of breath, chills, muscle pain, headache, sore throat, loss of smell/taste, nasal congestion, runny nose, fatigue, nausea or vomiting, diarrhea, or phlegm) within 5 days prior to baseline visit. 5. Participants (or their legal guardians) who understand the clinical trial contents, agree to participate, and provide written informed consent with their signature. 6. Contraceptive Use for Women of Childbearing Potential and Men with Fertile Partners Women of childbearing potential and men with fertile partners must agree to use appropriate contraceptive methods during the trial and for 90 days following the last dose of the investigational drug. (Exemptions apply for women who are infertile due to surgery, have lost ovarian function, or have been post-menopausal for at least one year.) Appropriate contraceptive methods include hormonal contraceptives, intrauterine devices, intrauterine systems, or dual-barrier methods (male condom with occlusive cap, cervical cap, or diaphragm with spermicide), as well as surgical sterilization procedures (e.g., vasectomy, tubal ligation).
Exclusion criteria
Exclusion criteria: 1. Individuals with known or suspected hypersensitivity to the active ingredients in APRG 64, including Geranium thunbergii (Sennakcho) or Galla rhois, and other excipients. 2. Individuals with genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 3. Severe COVID-19 Symptoms at Baseline Individuals showing one or more of the following severe COVID-19 symptoms: Blood oxygen saturation (SpO2) 30 breaths per minute. 4. Requirement for Oxygen Therapy or Critical Care at Baseline Individuals requiring oxygen therapy (e.g., nasal prong, facial mask, high-flow oxygen), mechanical ventilation (NIV or high-flow, intubation, or mechanical ventilation), or critical care support (e.g., ECMO, CRRT) due to severe respiratory failure, shock, or multi-organ failure. 5. Comorbidities at Screening Individuals with the following conditions at screening: Viral diseases other than COVID-19 that require antiviral treatment, such as active hepatitis B [positive hepatitis B virus surface antigen (HBsAg)] or active hepatitis C (individuals with positive anti-HCV but negative HCV RNA may participate). Suspected active bacterial, fungal, or other infections not related to COVID-19. Liver function abnormalities: AST or ALT levels = 5 times the upper limit of normal (ULN) or total bilirubin = 1.5 times the ULN. Severe renal impairment (serum creatinine > 2 mg/dL or estimated creatinine clearance < 30 mL/min/1.73 m² using the Cockcroft-Gault formula). Malignant tumors, severe central nervous system diseases, cardiovascular conditions (except controlled hypertension*), or significant endocrine disorders that would make participation difficult, as judged by the investigator. *Individuals with stable antihypertensive treatment maintaining BP below 140/90 mmHg may be eligible. Autoimmune disease patients who have taken immunosuppressants or immunomodulators (except corticosteroids) within the last 3 months. 6. Prohibited Medications or Therapies Prior to Trial Individuals who have taken prohibited medications that may affect the evaluation of the investigational drug within 7 days or 5 times the drug’s half-life (whichever is longer). Those who have used systemic corticosteroids (including inhalers) within 4 weeks before trial drug administration, except for topical, ocular, intra-articular, intranasal routes, or systemic corticosteroids at =10 mg/day prednisolone or equivalent. 7. Receipt of Standard Treatments That Could Interfere with the Investigational Drug Prior use of antiviral or anti-SARS-CoV-2 medications, such as remdesivir, Paxlovid, chloroquine, hydroxychloroquine, dexamethasone, interferon beta-1b, ribavirin, or protease inhibitors (e.g., lopinavir/ritonavir). Previous administration of SARS-CoV-2 immunoglobulins, convalescent plasma therapy, or any biologics or monoclonal antibodies for SARS-CoV-2 treatment. 8. Heart Rate Abnormalities Individuals with a pulse rate below 60 beats per minute (if the pulse is below 60 bpm on the first measurement, a second measurement is taken 10 minutes later, and if bradycardia persists, the individual is excluded). 9. Pregnant or Breastfeeding Women 10. Recent SARS-CoV-2 Vaccination Individuals who received a SARS-CoV-2 vaccine within 30 days prior to baseline. 11. Recent Participation in Other Clinical Trials Participation in other clinical trials involving investigational drugs or medical devices within 30 days prior to rece
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of days required for COVID-19 symptoms to improve and remain stable for more than 48 hours after administration of the investigational drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of APRG64; Adverse reactions that occurred after treatment, serious adverse reactions that occurred after treatment | — |
Countries
Korea, Republic of
Contacts
Public ContactJUN YOUNG SONG
Koera University Guro Hospital
Outcome results
None listed