Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Sponsors
Laos National Institute of Public Health
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Common to severe COVID-19 patients: 2. No gender limit, aged 18 to 80 years(as of screening date); 3. Eligible patients are evaluated on the basis of: (1) Epidemic history; (2) Positive test for SARS-CoV-2 virus; (3) Abnormal CT; (4) Fever, cough, shortness of breath or pulmonary rales; (5) Respiratory rate 93%, no serious symptoms or ICU care; 4. Signed a written informed consent, voluntarily randomized into the placebo group or the DG group, and underwent a series of chest CT and other lung, liver, heart, and kidney tests, as well as quality of life questionnaires (SF-36 and ECOG); 5. Avoid licorice products (e.g. licorice candy, licorice tea, supplements).
Exclusion criteria
Exclusion criteria: 1. Subjects with other types of lung infections (such as tuberculosis) or chronic lung diseases (COPD, chronic bronchitis, obstructive emphysema, occupational lung disease). 2. Subjects with hypertension (systolic blood pressure >=140mmHg or diastolic blood pressure >=90mmHg), pulmonary infarction, or the following: (1) Subjects at risk of hypokalemia, and subjects taking medications associated with hypokalemia (such as circuit diuretics); (2) Subjects with a history of uncontrolled hypertension or hypertension-related end-organ damage (such as CVA, microangiopatic hemolytic anemia, and hypertension-related nephropathy); (3) Subjects with hypokalemia and/or hypernatremia at screening; (4) Subjects with a history of endocrine disease involving the renin-aldosteron-angiotensin axis and congenital 11ß-hydroxy steroid dehydrogenase deficiency; (5) Subjects with abnormal creatinine clearance or eGFR or high creatinine levels. 3. Subjects with a history of recurrent or chronic infection, or underlying conditions that may further predispose the subject to severe infection. 4. In the 3 months prior to screening, the subject had taken hydroxychloroquine, immunosuppressants (corticosteroids, methotrexate, cyclophosphamide, cyclosporine, and azathioprine), and biologic agents such as the other antiviral drugs abatasepil, etanercept, infliximab, epritrezumab, and rituximab. 5. A history of moderate to severe congestive heart failure or any other uncontrolled heart disease, or a history of clinically significant electrocardiogram abnormalities (ECG) at the time of screening, according to the New York Heart Association (NYHA) Functional Classification System. 6. Use products with ammonium glycyrrhizate flavor and sweetness 3 days before registration. 7. Subject has a current or history of severe, progressive, or uncontrolled kidney, liver, hematology, gastrointestinal, endocrine, or brain disease, as well as any other medical or mental illness that the investigator deems unsuitable for admission to this study. 8. Evidence of hepatorenal insufficiency or hematological disease, abnormal laboratory tests in any of the following at screening: (1) Aspartate aminotransferase (AST) >=3 times the upper limit of normal (ULN); (2) Alanine aminotransferase (ALT) >= 3 x ULN; (3) Total bilirubin >=2 x ULN; (4) Serum creatinine >=3.0 x ULN; (5) The absolute count of neutrophils (ANC) <= 1.0x10^9/L; (6) Platelet count <= 100x10^9/L. 9. Known allergy to the test drug or any component of DG. 10. Failure to comply with protocols or study requirements. 11. Any other conditions that the investigator deems inappropriate to enter into this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| lung CT evaluation;improvement of clinical symptoms;changes of plasma inflammatory molecules; | — |
Secondary
| Measure | Time frame |
|---|---|
| sequela of COVID 19;vital organ function; | — |
Countries
Laos
Contacts
Public ContactLatsamy Siengsounthone
Laos National Institute of Public Health
Outcome results
None listed