COVID-19
Conditions
Interventions
Test group:Oral, KD-1 capsule 50mg/ capsule, 4 capsules/times, 3 times a day
For at least 7 days, the investigator may decide whether to continue the drug based on whether the subject has achieved an overall remission of clinical symptoms. The duration of the drug may not exce
Placebo group:Oral, KD-1 capsule simulation agent 50mg/ capsule, 4 capsules/times, 3 times a day
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age = 2 points: respiratory symptoms: Nasal congestion or runny nose, sore throat, shortness of breath or difficulty breathing, cough; Systemic symptoms: fatigue, muscle or body pain, chills, fever (axillary temperature >= 37.3 ?); Other: nausea, vomiting, diarrhea, headache. 5. The subject agrees to take effective contraception within 6 months after the study drug is first administered; 6. The subject is willing and able to comply with all visit arrangements, treatment plans, laboratory tests and other study procedures and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with definite other respiratory virus infection; 2. Patients who had used KD-1 capsule 3 months before screening; 3. Patients who have used drugs with pharmacological or clinical effects against novel coronavirus or traditional Chinese medicine containing "forsythia" within 7 days before screening, including but not limited to Paxlovid, azifudine, etc.; 4. Patients who have received COVID-19 monoclonal antibodies, convalescent plasma, or other concomitant drugs within 28 days prior to screening or who are receiving them; 5. Patients who received SARS-CoV-2 vaccine 28 days before screening were scheduled to receive SARS-CoV-2 vaccine during the visit period and follow-up period; 6. Immunodeficient patients (such as patients with malignant tumors, organ or bone marrow transplants, AIDS patients, long-term use of corticosteroids or other immunosuppressive drugs resulting in immune dysfunction); 7. Obese patients (body mass index >=30kg/m^2); 8. Heavy smokers (smoking index >=400 cigarettes per year); 9. Patients with serious cardiovascular and cerebrovascular diseases, chronic pulmonary diseases (chronic obstructive pulmonary disease, moderate to severe asthma, interstitial pulmonary disease), poorly controlled diabetes, chronic liver diseases (ALT or AST >=3ULN, total cholerine >=1.5ULN), kidney diseases (serum creatinine >=1.5ULN), tumors and other underlying diseases; 10. Patients who are known to be allergic to the ingredients contained in the study drug, or patients with allergic constitution; 11. Dysphagia or any history of gastrointestinal disease that affects drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, post-subtotal gastrectomy, etc.); 12. Women who are breastfeeding or pregnant, or patients who have a positive urine pregnancy test or who do not agree to participate in contraception within 3 months after the end of the test; 13. Suspected or confirmed history of alcohol, drug abuse or mental illness; 14. Patients who participated in clinical trials of other drugs within 3 months prior to screening; 15. Other patients considered unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from initial administration to general remission of clinical symptoms;Incidence of SAE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time between the first dose and the first negative nucleic acid;Proportion of subjects with negative nucleic acid test;CT values of N gene and ORF gene compared to baseline Area under CT-time curve (AUC);CT values of N gene and ORF gene changed from baseline;Overall response rate of clinical symptoms;Change of inflammatory markers from baseline and recovery rate;Time and rate of relief from first administration to respiratory clinical symptoms;Time and rate of partial remission of clinical symptoms after initial administration;Change in all COVID-19 symptoms and each COVID-19 symptom severity score from baseline;Time of resolution of all COVID-19 symptoms and individual COVID-19 symptoms (score 0) by day 28 of initial administration;Area under the symptoms-time curve (AUC) for all COVID-19 symptoms and each COVID-19 symptom score compared to baseline;The recurrence rate of fever after the body temperature has normalized;Frequency of symptomatic drug use;Proportion of subjects with all-cause death by day 28 of initial dosing;Proportion of subjects who had progressed to severe/critical COVID-19 by day 28 of initial administration;The incidence of mild to normal type was observed on the 28th day of initial administration; | — |
Countries
China
Contacts
Public ContactZhong Nanshan
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed