Treatment of adult patients with mild to moderate novel coronavirus infection (COVID-19)
Conditions
Interventions
Clarithromycin group:Clarithromycin+JT001
Cyclosporine group:Cyclosporine+JT001
Sponsors
Henan Infectious Disease Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. age: 18 years= kg for men and >=45 kg for women; 2.body mass index (BMI) within the range of 19-26 kg/m^2 (including 19 and 26 kg/m^2); 3. good health status, i.e., normal or abnormal vitals, physical examination, laboratory tests, ECG and ultrasound without clinical significance; 4. will be able to use reliable contraception during the trial and for 3 months after taking the drug (see section 10.4 Annex 4 for details); 5. fully understand the purpose, content and possible adverse effects of the trial, voluntarily participate in the clinical trial and sign the written informed consent, and be able to complete all the trial procedures and comply with the trial regulations according to the trial requirements.
Exclusion criteria
Exclusion criteria: 1. known history of allergy to the test preparation and any of its components or related agents; 2. Subjects with allergic diseases or allergic individuals; 3. persons with definite diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic disorders, etc. and requiring medical intervention or other diseases that are not suitable for participation in clinical trials (e.g., history of psychiatric disorders, etc.); 4. those who have donated blood or lost >= 400 mL of blood within 3 months prior to enrollment, or have a history of blood product use; 5. those who have participated in other drug clinical trials within 3 months prior to enrollment and are taking the test drug; 6. who have used any prescription drugs, over-the-counter drugs, herbal medicines or health supplements within 2 weeks prior to screening; 7. who have used any vaccine within 2 weeks prior to screening; 8. who have undergone prior surgery that may affect the absorption, distribution, metabolism, or excretion of the drug (e.g., major gastrectomy) or who anticipate that surgery or hospitalization may be planned during the trial; 9. a history of drug dependence or abuse within 1 year prior to screening, or a positive urine drug screening test; 10. who have used a strong inhibitor of P-gp or BCRP within 2 weeks prior to screening (see section 10.6, Annex 6 for details); 11. have ingested grapefruit/grapefruit juice, food or beverages rich in methylxanthines (e.g. coffee, tea, cola, chocolate, functional drinks) within 48h prior to dosing, or have had strenuous exercise and other factors affecting drug absorption, distribution, metabolism, excretion, etc; 12. a person who was an alcohol addict within 1 year prior to screening, who consumed alcohol at least twice daily or more than 14 units per week, or who was an avid alcoholic (1 unit ˜ 200 mL of beer with an alcohol content of 5% or 25 mL of spirits with an alcohol content of 40% or 85 mL of wine with an alcohol content of 12%); 13. addicted to tobacco within 1 year prior to screening, smoking more than 10 cigarettes or equivalent per day; 14. those who are unable to abstain from smoking or alcohol during the trial; 15. those who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), syphilis spirochete antibody and HIV antibody; 16. those with abnormal and clinically significant results on chest X-ray (front and side view); 17. those whose glutamic aminotransferase (ALT) or glutamic oxalacetic aminotransferase (AST) exceeds the upper limit of normal (ULN) at screening or at baseline; 18. glomerular filtration rate (eGFR) 450 ms in men and > 470 ms in women and/or other abnormalities of clinical significance; 20. pregnant or lactating women or male subjects whose spouse has a child-rearing plan within 3 months; 21. those who have other factors that, in the opinion of the investigator, make them unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK (AUC0-8, AUC0-t, Cmax); | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and serious adverse events;PK (Tmax?t1/2?Vz/F?CL/F); | — |
Countries
China
Contacts
Public ContactShuang Li
Henan Infectious Disease Hospital
Outcome results
None listed