None listed
Conditions
Interventions
Drug : 1. Drugs for clinical trials
1) Test medication 1: 500 milligrams of Diabex Table (Diabex Tab. 500 mg)
- Main ingredients and contents: Metformin hydrochloride (500 mg of Metformin hydrochlor
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Adults with a PASC score of 12 or higher at screening (ages 19 and older) after clinical suspicion of COVID-19 at least 30 days and up to 730days(2years) prior to screening and being diagnosed as SARS-CoV-2 positive by RT-PCR or rapid antigen test results 2) A person whose rapid antigen test results are negative during screening 3) A person who voluntarily agrees in writing to participate in this clinical trial
Exclusion criteria
Exclusion criteria: 1) People who are allergic to metformin or ursodeoxycholic acid 2) a patient on metformin 3) Patients on ursodeoxycholic acid (UDCA) 4) Those hospitalized for COVID-19 or other reasons 5) Patients with respiratory infections such as flu, other things that can cause fatigue Diseases (hyperthyroidism, hypothyroidism, chronic fatigue syndrome, rheumatoid disease, etc.) 6) Glomerular filtration rate below 45ml/min/1.73m2 or dialysis patients, radiation within 48 hours, patients undergoing intravenous examination of iodine contrast agents, severe infections, malnutrition,a patient with pituitary/adrenal insufficiency, peptic ulcer, and Crohn's disease. 7) a patient with severe biliary obstruction 8) patients with nonfunctional or acute cholecystitis 9) a patient with fulminant hepatitis 10) Those enrolled in other blind, randomized, controlled clinical trials for COVID-19 11) Those who have received monoclonal antibody treatment against COVID-19 12) Alcohol abuse patients 13) A person who has a disease in the liver, kidney, nervous system, respiratory system, endocrine system, blood/tumor, cardiovascular system, and urinary system that may affect the interpretation of the results of clinical trials at the time of screening 14) Pregnant women or nursing mothers 15) A childbearing woman or man who is not willing to use appropriate contraception* during this clinical trial *Hormonal contraceptives, implantation of intrauterine devices or intrauterine systems, vasectomy, ligation of ovaries, double blocking contraception (such as cervical cap or simultaneous use of contraceptive septum and men's condoms), etc 16) In addition to the above, a person who determines that the tester is not suitable for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the test group 1 with the control group, an analysis will be conducted to see the difference in the improvement rate of patients whose PASC score improves from 12 or more to less than 12 at the time of the baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The average change in the three groups Post-Acute Sequel of COVID-19 (PASC) score improvement values at 8 weeks of treatment compared to the baseline. 2) Mortality 3) Hospitalization rate during the follow-up period; admission rate following-up 4) Improvement and recovery rate of scores for specific symptoms (fatigue, chest pain, brain fog, cognitive impairment, depression scale, quality of life scale 5) Analysis of symptom improvement according to the timing of drug administration (1-2 months, 3-4 months, 5-6 months or within 3 months, 6 months) in patients with COVID-19 sequelae (6) Improvement analysis of immune markers such as IL-10, IP-10, and RANTES | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-Han Kim
Asan Medical Center
Outcome results
None listed