novel coronavirus pneumonia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: o be enrolled, all the following criteria must be met: 1) the confirmed patient (or legal guardian) agrees to participate in the study and signs the informed consent; 2) Aged 18-65 years, gender not limited; 3) the time interval between symptom onset and random enrollment was within 8 days (symptom onset was mainly determined by the time of fever); 4) real-time fluorescence rt-pcr detection of respiratory tract or blood samples in patients with positive nucleic acid of novel coronavirus; 5) diagnosis of mild, common or severe cases according to the diagnosis and treatment plan for pneumonia caused by novel coronavirus (trial version 5): A. Mild: the clinical symptoms were mild, and no pneumonia was found on imaging; B. Common type: symptoms such as fever and respiratory tract, and manifestations of pneumonia can be seen on imaging; C. Heavy: meets any of the following: A. respiratory distress, respiratory frequency >= 30 times/min; B. At rest, oxygen saturation (SaO2) <= 93%; C. Arterial partial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) <= 300mmHg.
Exclusion criteria
Exclusion criteria: You cannot be enrolled if you meet any of the following criteria: 1) any situation that cannot allow the program to proceed safely; 2) allergic constitution, allergic to more than one kind of food or medicine; 3) patients with severe basic diseases that affect survival, including uncontrolled clinically significant heart, lung, kidney, digestion, blood diseases, neuropsychiatric diseases, immune diseases, metabolic diseases, malignant tumors, and severe malnutrition; 4) pregnant or lactating women; 5) patients may be transferred to non-participating hospitals within 72 hours; 6) patients who have been on immunosuppressive agents or organ transplants for nearly 6 months; 7) critically ill patients diagnosed according to the diagnosis and treatment plan for pneumonia caused by novel coronavirus infection (trial fifth edition); 8) those who are unable to cooperate in mental state, suffer from mental illness, have no self-control and cannot express clearly; 9) a history of HBV, HCV, TPPA, HIV and pancreatitis before infection; 10) participants in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time required for RNA Yin conversion of novel coronavirus in respiratory or blood specimens was compared between treatment groups The difference of; | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in mean clinical recovery time between treatment groups were compared;The proportion of subjects for the novel coronavirus RNA in respiratory or blood samples at day 7 of treatment was compared between treatment groups;RNA negative ratio of subjects for The novel coronavirus in respiratory or blood samples at day 14 of treatment was compared between treatment groups;In the light cohort, the proportion of subjects who progressed to pneumonia at day 7 of treatment was compared between treatment groups;Pneumonia severity index at day 14 of treatment was compared between treatment groups in the general and heavy cohort (PSI) differences, chest imaging differences (chest CT);In normal subjects,the ratio of subjects who progressed to severe pneumonia on day 14 of treatment were compared between treatment groups;In normal and heavy queues,the ration of Progression to critical pneumonia at day 14 of treatment were compared between treatment groups;The proportion of subjects who died of illness at day 28 and day 84 were compared between treatment groups; | — |
Countries
China
Contacts
The First Affiliated Hospital of Medical College of Zhejiang University