Study period | Lead-in period | Treatment period | ||||
---|---|---|---|---|---|---|
Follow-up times | 1 | 2 | 3 | 4 | 5 | 6 |
Time point | 0 Day | 24 h | 48 h | 72 h | 96 h | 120 h |
Case screening | ||||||
History | √ | |||||
Indicator check | √ | √ | √ | |||
Basic information | √ | |||||
Determine the inclusion | √ | |||||
Informed content | √ | |||||
Indicator check | ||||||
Temperature | √ | √ | √ | √ | √ | √ |
BP/HR/P/symptoms/signs | √ | √ | √ | √ | √ | √ |
Blood routine/Urine routine | √ | √ | ||||
Liver function/Kidney function | √ | √ | ||||
Twelve-lead ECG | √ | √ | ||||
Pathogen test | √ | √ | ||||
Inflammatory factor test | √ | √ | ||||
Others | ||||||
randomization | √ | |||||
Drug distribution | √ | |||||
Drug recycle/ medication compliance | √ | |||||
Combined medication | √ | √ | √ | √ | √ | |
AEs | √ | √ | √ | √ | √ | |
Recycle drug | √ | |||||
Conclusion of Completion of experiment | √ |