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To summarize and analyze clinical development strategy and the key considerations of clinical trial design of drugs for the treatment of corona virus disease 2019 (COVID-19) at home and abroad in recent years, including ribonucleic acid (RNA) polymerase inhibitors, 3CL protease inhibitors, and neutralizing antibodies, etc. In general, the confirmatory clinical trials for therapeutic drugs for COVID-19 typically adopt a randomized, double blind, placebo-controlled clinical trials using a superiority design. Based on their therapeutic positioning, most trials mainly enroll patients with mild to moderate COVID-19, with or without high-risk of complications, and the primary efficacy endpoints are the proportion of patients hospitalized or mortality by an appropriate time point, or the time to sustained clinical recovery assessed over an appropriate duration. Through reviewing drug development during the COVID-19 pandemic, this paper summarized the considerations and changes for clinical research and development, as well as the focus of clinical trial design for new drugs in the treatment of COVID-19, in the context of emerging and sudden major infectious diseases, hoping to provide references for drug research and development.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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