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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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KCT |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
KCT0009342 |
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Date of registration:
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2024-04-15 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Exploratory double-blind randomized placebo-controlled trial of Metformin and Ursodeoxycholic acid (UDCA) to treat post-acute sequelae of SARS-CoV-2 infection (PASC)
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Scientific title:
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Exploratory double-blind randomized placebo-controlled trial of Metformin and Ursodeoxycholic acid (UDCA) to treat post-acute sequelae of SARS-CoV-2 infection (PASC) |
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Date of first enrolment:
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2024-04-01 |
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Target sample size:
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396 |
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Recruitment status: |
Recruiting |
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URL:
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https://cris.nih.go.kr/cris/search/detailSearchEn.do?seq=26609 |
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Study type:
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Interventional Study |
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Study design:
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Primary Purpose : Treatment, Intervention Model : Parallel, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Allocation : RCT
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Phase:
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Phase4
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Sung-Han
Kim |
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Address:
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88. olympic-ro 43-gil , Songpa-gu, Seoul, 05505, South Korea
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Telephone:
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+82-2-3010-3305 |
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Email:
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shkimmd@amc.seoul.kr |
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Affiliation:
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Asan Medical Center |
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Name:
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Sung-Han
Kim |
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Address:
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88. olympic-ro 43-gil , Songpa-gu, Seoul, 05505, South Korea
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Telephone:
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+82-2-3010-3305 |
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Email:
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shkimmd@amc.seoul.kr |
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Affiliation:
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Asan Medical Center |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) Adults with a PASC score of 12 or higher within 6 months of infection with SARS-CoV-2 virus (over 18 years of age)
2) A person who voluntarily agrees to participate in this clinical trial
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 decreased renal function: eGFR <30 mL/minute/1.73 m2 or dialysis patients
6) a patient with severe biliary obstruction
7) patients with nonfunctional or acute cholecystitis
8) a patient with fulminant hepatitis
9) Those enrolled in other blind, randomized, controlled clinical trials for COVID-19
10) Those who have received monoclonal antibody treatment against COVID-19
11) Alcohol abuse patients
12) 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
13) Pregnant women or nursing mothers
14) 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
15) In addition to the above, a person who determines that the tester is not suitable for participation in this clinical trial
Age minimum:
No Limit
Age maximum:
No Limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Codes for special purposes
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Intervention(s)
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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 hydrochloride)
- Characteristics: White circular film coating crystal
- Manufacturer: Daewoong Pharmaceutical Co., Ltd
2) Test medication 2: 300 milligrams of Ursa tablet (Ursa Tab. 300mg)
- Main ingredients and contents: urusodeoxycholic acid, 300mg
- Constellation: White Circular Refining
- Manufacturer: Daewoong Pharmaceutical Co., Ltd
3) Test drug 1 placebo: 500 milligrams of Diabex tablet placebo
- Principal Components and Content: Not Applicable
- Characteristics: White circular film coating crystal
- Manufacturer: Daewoong Pharmaceutical Co., Ltd
4) Placebo on trial drug 2: 300 milligrams of urusa tablet
- Principal Components and Content: Not Applicable
- Constellation: White Circular Refining
- Manufacturer: Daewoong Pharmaceutical Co., Ltd
2. Period and method of administration of clinical trial drugs
Subjects who meet the selection criteria and do not meet the exclusion criteria are randomly assigned to one of the test group 1, test group 2, or control groups at a 1:1:1 ratio and administer clinical trial drugs as follows.
- Test Group 1: Diabex tablets + Urusa tablets placebo
- Test Group 2: Diabex tablet placebo + urusa tablet
- Control group: Diabex tablet placebo + Ursa tablet placebo
1) orally administered a DIABEX tablet or a DIABEX tablet placebo
- On the first day, one tablet is administered once in the morning
- On the 2nd to 5th day, administer one tablet twice a day (morning and evening)
- administer one tablet in the morning and two tablets in the afternoon on the 6th to 14th day
2) A total of three tablets of urusa or placeb
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Ministry of Health & Welfare
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Ethics review
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Status: Submitted approval
Approval date: 04/03/2024
Contact:
IRB(Institutional Review Board) of Asan Medical Center in Seoul
+82-2-3010-7166
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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