COVID-19
Conditions
Interventions
LHQW group:Standard of Care (SOC) + LHQW: 4 capsules / time, 3 times/day
Placebo group:SOC + placebo: 4 capsules / time, 3 times/day
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Adult patients with mild or moderate COVID-19 (WHO criterion), who received positive results on SARS-CoV-2 rapid antigen test or RT-PCR for confirmation of SARS-CoV-2 infection 2.Adult men and non-pregnant women, between 18 and 70 years old (including 18 and 70 years old). 3.The time interval between the onset of symptoms and screening shall be not exceed 4 days. (the occurrence of signs and symptoms of COVID-19 may appear on the 2nd to 14th days after exposure to SARS-CoV-2. The onset of symptoms is defined as occurring at least one of the following symptoms: cough, stuffy or runny nose, sore throat, shortness of breath (difficulty breathing), low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea, new loss of smell, and new loss of taste.) 4.At least 3 of the 9 major symptoms (stuffy or runny nose, sore throat, cough, shortness of breath (difficulty breathing), low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish) occur within 12 hours before screening. 5.Can understand and comply with the requirements of the protocol, and can provide a signed written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients who meet COVID-19 diagnostic criteria of severe diseases or above. 2.By the assessment of investigator, patients who occur any of the following serious chronic systemic diseases that may affect the efficacy evaluation and disease regression: ?Poorly controlled diabetes (randomized blood glucose >11.1 mmol/L within 7 days prior to enrolment or glycated hemoglobin =8% within the last 3 months in the case of standardized glucose-lowering therapy); ?Poorly controlled hypertension (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg despite regulated use of antihypertensive medication); ?Chronic lung disease, including COPD (chronic obstructive pulmonary disease), asthma, interstitial lung disease, cystic fibrosis and pulmonary hypertension); ?Tumors, severe cardiovascular diseases (heart failure, cardiomyopathy, dementia, mental disorders, etc.), diseases that seriously affect the immune system, etc. ?Chronic kidney disease (including chronic kidney disease stages 3-5), chronic liver disease (e.g. liver fibrosis, cirrhosis, or serum AST and/or ALT = 3 times the upper limit of normal). ?Severe obesity: BMI =35 kg/m2. 3.Patients with known co-morbidities of other infections. 4.Patients with a history of alcohol or drug abuse (other than cannabis use) within 1 year prior to enrollment. 5.Those participated in other clinical trials within 1 month prior to screening. If the investigational product has a long half-life, the time interval should be more than 5 half-lives from the last administration to screening of this study. 6.Persons with a known or suspected history of allergy or hypersensitivity to the investigational product and its excipients. 7.Female patients who are pregnant, breastfeeding or within 2 weeks of delivery. 8.Patients who, in the opinion of the investigator, are not suitable to participate in the study due to a possible breach of the trial protocol or any other circumstances affecting their safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median time to sustained improvement or resolution of 9 major symptoms. (14d observation period); | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging (CT/chest x-ray) improvement rate. (14d observation period) (evaluation at conditioned centers);Median time to sustained improvement or resolution of smell losing and taste losing; (14d observation period);Changes in infection-related inflammatory factors (white blood cell count, lymphocyte count, C-reactive protein, D-dimer (sites in Vietnam needs to do interleukin IL-6, D dimer 8 times)); (14d observation period);Time to obtain negative result on SARS-CoV-2 virus tests and the rate of virus nucleic acid negative conversion. (planned testing dates: days 0, 7, 10, 14);Incidence of COVID-19-related severe/critical disease. (14d observation period);Median time to onset of antipyretic effect and return to normal body temperature; (14d observation period);Median time to sustained improvement or resolution of individual symptoms of the 9 primary symptoms; (14d observation period);Median time to sustained improvement or resolution of gastrointestinal symptoms; (14d observation period);Incidence of COVID-19-related and all-cause mortality within 14 days. (14d observation period);Proportion of patients with all clinical symptoms' improvement or resolution; (14d observation period);Proportion of patients with sustained improvement or resolution of 9 major symptoms; (14d observation period); | — |
Countries
China
Contacts
Public ContactZheng Jinping
Outcome results
None listed