None listed
Conditions
Interventions
Medical Device : 1) Intervention: Application of interventional treatment by group
- Control group: Symptomatic + Sham Bye-Vi (fake device of the same shape)
- Test group: Symptomatic therapy + Bye-
Sponsors
Nanobioimaging
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women between the ages of 19 and 65 2) Those who have been confirmed to have COVID-19 by rapid antigen test or PCR 3) Those who do not require supplemental oxygen therapy with confirmed mild or moderate COVID-19 infection who have developed one or more COVID-19-related symptoms* within 2 days prior to randomization 4) A person whose sum of symptom scores of 1-11 of the symptom items is 8 points or more 5) A person who voluntarily decided to participate and gave written consent to abide by the precautions after hearing a detailed explanation of this clinical trial and fully understanding it * COVID-19-related symptoms: fever, cough, sore throat, headache, muscle pain, chills/tremors, runny nose/congestion, phlegm, fatigue/malarial, shortness of breath/breath, nausea/nausea, vomiting, diarrhea
Exclusion criteria
Exclusion criteria: 1) If you have had one or more of the following infectious diseases in the past or present - Viral diseases other than coronavirus infection that require administration of other antiviral drugs (HIV, HBV, HCV, etc.) - A person who has been confirmed to have a bacterial infection and is currently receiving treatment 2) A person with symptoms of respiratory infection accompanied by one or more of the following symptoms: respiratory rate of 30 times/min or more, severe dyspnea, or oxygen saturation (SpO2) of 93% or less without oxygen administration 3) Those who have received drugs such as antiviral drugs, neutralizing antibody treatments, plasma fractionation treatments, and other immune modulators (cytokine treatments, etc.) for the purpose of treating COVID-19 infection within 28 days prior to screening 4) Those who have been vaccinated with the bivalent COVID-19 vaccine (Reason: In this clinical trial, we will include those who have been vaccinated with the monovalent vaccine to proceed under conditions similar to the participants' immune status) 5) Under the judgment of the investigator, those who have a respiratory disease and are using drugs for it as an underlying disease that is unsuitable for participation in the clinical trial, or who have a chronic underlying disease and other reasons, who are judged unsuitable to participate in this clinical trial by the principal researcher ruler 6) Those with photosensitivity or photoallergy 7) Those with a history of alcoholism, those with a history of substance abuse or prescription/inappropriate drug use (e.g., contraceptives, systemic steroids, intranasal drugs, antibiotics, etc.) within 3 months of screening 8) A person who is judged unfit to participate in a clinical trial by the trial director for reasons other than the above exclusion criteria 9) Patients who have participated in other clinical trials within 1 month before obtaining informed consent 10) Pregnant and lactating women, those who tested positive for pregnancy on urine tests, those who are expected to become pregnant during the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCR test (viral load) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Symptom Score;Clinical symptom score improvement time;Erythrocyte Sedimentation Rate;complete blood cell count with difference count, CBC with DC;C-reactive protein test | — |
Countries
Korea, Republic of
Contacts
Public ContactSEUNG-ROK KANG
Jeonbuk National University Hospital
Outcome results
None listed