COVID-19
Conditions
Interventions
Experimental group:Ganmaoan granule
Control group:Placebo particles for colds
Sponsors
The First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 60 years, including critical value, male and female; 2. Non-severe patients with SARS-COV-2 infection confirmed by PCR within 3 days prior to randomization; 3. Signed informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Severe, severe/critical high-risk groups with confirmed novel coronavirus infection; 2. Respiratory tract bacterial infection, congenital respiratory malformation, congenital heart disease, gastroesophageal reflux, lung malformation caused by primary or secondary immunodeficiency; 3. Asthma or other chronic airway diseases that require maintenance treatment, acute respiratory bacterial infections (such as bronchiectasis, tonsillitis, bronchitis, sinusitis, otitis media), severe pulmonary interstitial disease; 4. Patients with severe systemic diseases (including but not limited to malignant tumors, autoimmune diseases, liver or kidney diseases) or surgery (splenectomy, organ transplantation) that may affect the evaluation of efficacy and have not been stabilized by the investigator; 5. Pregnant and lactating women; 6. Participated in other clinical trials within 1 month; 7. Known allergy to the drug under study; 8. Have taken heat-clearing and detoxifying traditional Chinese medicine preparations within 48 hours before randomization; 9. Other conditions that the researchers judge are not suitable for participating in the project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness: After administration, clinical symptoms fever, sore throat, head discomfort, fatigue, recovery time disappear symptoms;Safety: Adverse reactions/events and serious adverse events after administration. Safety indicators include: life signs, clinical laboratory examination indicators (blood routine, urine routine, blood biochemistry, CRP, myocardial enzyme spectrum, etc.), physical examination, pain and cough schemes.; | — |
Secondary
| Measure | Time frame |
|---|---|
| After administration, the recovery rate of disappearing symptoms such as fever, sore throat, head discomfort, fatigue, cough, etc. during the treatment and observation period of treatment;After the administration, the subjects of fever, sore throat, head discomfort, fatigue, cough, and other symptoms of disappearing symptoms;;After the administration, the clinical symptoms of fever, sore throat, head discomfort, fatigue of fever, sore throat, head discomfort, and fatigue during the treatment period and observation period are all disappeared;After administration, the average time of the numeric virus nucleic acid detection of negative virus RNA is lower than the detection limit and/or CT value >= 35);After the administration, the visits point of each nucleic acid test, the subject's pharynx swab virus nucleic acid detection negative (virus RNA copy number is lower than the detection limit and/or CT value >= 35);The proportion of the worse during treatment (the definition of severe and critical illness in the diagnosis and treatment plan);Proportion of CT improvements (if applicable); | — |
Countries
China
Contacts
Public ContactLi Zhang
The First Affiliated Hospital of Naval Medical University
Outcome results
None listed