A multicenter, double-blinded, randomized, parallel group and placebo-controlled clinical study of the efficacy and safety of Fuzheng Jiedu granules in the treatment of COVID-19

INTERVENTION: Control group:Placebo control;FZJDG:Fuzheng Jiedu granules; CONDITION: COVID‐19 PRIMARY OUTCOME: Duration of sustained clinical recovery; SECONDARY OUTCOME: WHO Clinical Progress Scale score;duration of symptoms about TCM patterns;Changes in chest CT scan image score from baseline at discharge;Change in single item scores compared to baseline for COVID‐19‐related target symptoms in the third, 5th, 7th, 14th from administration;Length of hospitalization;duration of SARS‐CoV‐2 Ct negative;Percentage of subjects with clinical recovery in the 7th and 14th day from administration;Changes in COVID‐19 symptom scores from baseline;Percentage of subjects whose CLINICAL Progress Scale score decreased by at least 1 point from baseline;Changes in SARS‐COV‐2 Ct values from baseline;Change from baseline in lymphocyte count, oxygen saturation (after 5 min of rest and exercise), arterial partial pressure of oxygen (PaO2), oxygen concentration (FiO2), fatigue, and sweating;Percentage of subjects' exacerbations and all‐cause deaths within 14 days; INCLUSION CRITERIA: Subjects must meet all of the following criteria: 1. SARS‐CoV‐2 positive; 2. Aged between 18 and 85 (including 18 and 85) 3. At the time of entry, the subject has at least one of the following clinical symptoms with a symptom score =1, including but not limited to: fever, cough, sore throat, stuffy or runny nose, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath or dyspnea, chills; 4. Subjects shall meet at least one of the following requirements: 1) The time between the samples tested positive for SARS‐COV‐2 and the first using of test drug is no more than 3 days; 2) =3 days from the first onset of COVID‐19 symptoms to the first administration of the investigational drug; 5. The TCM syndrome differentiation in screening period was divided into Yang deficiency and wet toxin not clear; Symptoms: pale complexion, fear of cold, cold limbs, fatigue, chest tightness, shortness of breath, nausea, poor stomach intake, thin stools, p