Novel coronavirus pneumonia(COVID-19)
Conditions
Interventions
Experimental group:DXP604
Control group:placebo
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The age of the patient at the time of signing the ICF shall be 18 to 70 years old (including 18 and 70 years old), no gender limit; 2. Venous access conditions are available, allowing drug administration and blood sample collection according to the study protocol; 3. Any samples confirmed by the laboratory were positive for SARS-CoV-2 within 96 hours prior to screening; 4. According to the ninth revised version of the Novel Coronavirus Pneumonia Diagnosis and Treatment Protocol of the National Health Commission of the People's Republic of China (NHC), the clinical classification of patients was light/ordinary type; 5. There is at least one risk factor for severe/critical high risk of COVID-19: (1) Aged > 60 years; (2) Patients with cardiovascular and cerebrovascular diseases (including hypertension), chronic pulmonary diseases (chronic obstructive pulmonary disease, moderate to severe asthma), diabetes, chronic liver and kidney diseases, tumors and other underlying diseases; (3) Immune deficiency (such as AIDS patients, long-term use of corticosteroids or other immunosuppressive drugs leading to immune dysfunction); (4) Obesity (BMI >= 30); (5) Heavy smokers; 6. Onset of COVID-19 symptoms <= 5 days before randomization, such as fever, cough, shortness of breath, sore throat, diarrhoea, vomiting and taste disturbance; 7. Consent to the collection of nasopharyngeal swabs, saliva and venous blood; 8. The patients are able to communicate well with the investigator, understand and comply with the requirements of the study, and understand and sign the ICF.
Exclusion criteria
Exclusion criteria: 1. Known allergy to the test drug and its components; 2. Hemodynamics were not stable within 24 h before treatment allocation, which required the use of pressors; 3. Suspected or confirmed severe, active bacterial, fungal, viral or other infections (other than COVID-19) that the investigator believes may pose a risk when taking interventions; 4. Any comorbiditions requiring surgery within 7 days prior to screening, or those considered life-threatening within 29 days prior to screening; 5. The investigator considers that participation in the study should be prevented from any serious systemic diseases, conditions, or disorders associated with the study; 6. Patients with anti-SARS-CoV-2 immunoglobulin G (IgG) test positive and IgG > 10; 7. Patients with malignant tumors who are undergoing chemotherapy or radiotherapy before and after surgery; 8. Those who have received SARS-CoV-2 specific immunoglobulin (including monoclonal antibody) treatment; 9. Those who have been vaccinated against COVID-19 within 1 month; 10. Patients with a history of receiving convalescent COVID-19 plasma therapy; 11. Received any investigational treatment for COVID-19 in the 30 days prior to administration, including but not limited to antivirals, corticosteroids, interleukin-1 inhibitors, interleukin-6 inhibitors, and intravenous immunoglobulin; 12. Participated in other drug clinical trials within 3 months prior to screening; 13. Dizzy with needles and blood; 14. Within 4 months after signing the ICF to the end of the trial, those who have a family plan or do not agree to use effective non-pharmaceutical contraceptive measures during this period; 15. Pregnant and lactating patients; 16. Additional factors considered inappropriate to be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 viral load in nasopharyngeal swabs;adverse events/serious adverse events;vital signs;physical examination;laboratory test; | — |
Countries
China
Contacts
Public ContactJin Ronghua
Outcome results
None listed