Evidence map›Paper›PMID 36577095›Full record

Trial reportThe New England journal of medicine2023

VV116 versus Nirmatrelvir-Ritonavir for Oral Treatment of Covid-19.

Zhujun Cao, Weiyi Gao, Hong Bao, Haiyan Feng, Shuya Mei, Peizhan Chen, Yueqiu Gao, Zhilei Cui, Qin Zhang, Xianmin Meng and 12 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05341609 (A Multicenter, Single-blind, Randomized, Controlled Study to Evaluate the Efficacy and Safety of JT001), which is not on this map. Cited by 102 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
102citing papers in PubMed, 6 pooled it
22.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05341609 phase3completednot on this map

A Multicenter, Single-blind, Randomized, Controlled Study to Evaluate the Efficacy and Safety of JT001 (VV116) Compared With Paxlovid for the Early Treatment of COVID-19 in Participants With Mild to Moderate COVID-19

TypeinterventionalSponsorVigonvita Life SciencesRan2022 to 2022Enrolled822ConditionsCOVID-19ArmsJT001, Paxlovid
3 · Its place in the literature

Who cites it

102 citing papers in PubMed, 6 syntheses or guidelines pooled it, 223 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
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  5. Nirmatrelvir combined with ritonavir for preventing and treating COVID-19.The Cochrane database of systematic reviews · 2023
    Pooled it
  6. Pooled it
  7. Trial
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  10. Trial
  11. Trial
  12. Article
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  14. Review
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  16. Observational
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  20. Review

42 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 8 institutions in 3 countries.

Zhujun CaoFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.ORCID 0000-0002-8684-2107
Weiyi GaoFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Hong BaoFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Haiyan FengFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Shuya MeiFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Peizhan ChenFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Yueqiu GaoFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Zhilei CuiFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Qin ZhangFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Xianmin MengFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Honglian GuiFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Weijing WangFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Yimei JiangFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Zijia SongFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Yiqing ShiFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Jing SunFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Yifei ZhangFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Qing XieFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Yiping XuFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Guang NingFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Yuan GaoFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Ren ZhaoFrom the Department of Infectious Diseases, Shanghai Institute of Virology (Z. Cao, H.G., W.W., Q.X.), the Department of Emergency Medicine, Shanghai Innovation Center for Digital Medicine (W.G.), the Clinical Research Center, Shanghai National Center for Translational Medicine, State Key Laboratory of Medical Genomics (P.C., Y.X.), the Departments of General Surgery (Y.J., Z.S., Y.S., R.Z.) and Gastroenterology (J.S.), the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases (Y.Z., G.N.), and Shanghai National Clinical Research Center for Metabolic Diseases, Key Laboratory for Endocrine and Metabolic Diseases of the National Health Commission of the People's Republic of China, Shanghai Key Laboratory for Endocrine Tumors (Y.Z., G.N.), Ruijin Hospital, the Department of Critical Care Medicine, Renji Hospital (S.M., Yuan Gao), the Department of Respiratory Medicine, Xinhua Hospital (Z. Cui), and the Department of Good Clinical Practice Office and Phase I Unit, Tongren Hospital (Q.Z.), Shanghai Jiao Tong University School of Medicine, the Department of Respiratory and Critical Medicine, Shanghai Pudong Hospital, Fudan University Pudong Medical Center (H.B.), the Departments of Pain Rehabilitation (H.F.) and Pharmacology (X.M.), Shanghai Public Health Clinical Center, Fudan University, and the Department of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Yueqiu Gao) - all in Shanghai, China.
Shanghai Institute of Hematology · CNNational Clinical Research · USShanghai Public Health Clinical Center · CNFudan University · CNRenji Hospital · CNShanghai Innovative Research Center of Traditional Chinese Medicine · CNShanghai Jiao Tong University · CNUniversity Gastroenterology · US

Funding

National Key Research and Development Program of China 2021YFC0865000National Natural Science Foundation of China 82000588National Natural Science Foundation of China 82088102Science and Technology Commission of Shanghai Municipality 22YJ1900600
6 · The paper itself

Abstract

backgroundNirmatrelvir-ritonavir has been authorized for emergency use by many countries for the treatment of coronavirus disease 2019 (Covid-19). However, the supply falls short of the global demand, which creates a need for more options. VV116 is an oral antiviral agent with potent activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

methodsWe conducted a phase 3, noninferiority, observer-blinded, randomized trial during the outbreak caused by the B.1.1.529 (omicron) variant of SARS-CoV-2. Symptomatic adults with mild-to-moderate Covid-19 with a high risk of progression were assigned to receive a 5-day course of either VV116 or nirmatrelvir-ritonavir. The primary end point was the time to sustained clinical recovery through day 28. Sustained clinical recovery was defined as the alleviation of all Covid-19-related target symptoms to a total score of 0 or 1 for the sum of each symptom (on a scale from 0 to 3, with higher scores indicating greater severity; total scores on the 11-item scale range from 0 to 33) for 2 consecutive days. A lower boundary of the two-sided 95% confidence interval for the hazard ratio of more than 0.8 was considered to indicate noninferiority (with a hazard ratio of >1 indicating a shorter time to sustained clinical recovery with VV116 than with nirmatrelvir-ritonavir).

resultsA total of 822 participants underwent randomization, and 771 received VV116 (384 participants) or nirmatrelvir-ritonavir (387 participants). The noninferiority of VV116 to nirmatrelvir-ritonavir with respect to the time to sustained clinical recovery was established in the primary analysis (hazard ratio, 1.17; 95% confidence interval [CI], 1.01 to 1.35) and was maintained in the final analysis (median, 4 days with VV116 and 5 days with nirmatrelvir-ritonavir; hazard ratio, 1.17; 95% CI, 1.02 to 1.36). In the final analysis, the time to sustained symptom resolution (score of 0 for each of the 11 Covid-19-related target symptoms for 2 consecutive days) and to a first negative SARS-CoV-2 test did not differ substantially between the two groups. No participants in either group had died or had had progression to severe Covid-19 by day 28. The incidence of adverse events was lower in the VV116 group than in the nirmatrelvir-ritonavir group (67.4% vs. 77.3%).

conclusionsAmong adults with mild-to-moderate Covid-19 who were at risk for progression, VV116 was noninferior to nirmatrelvir-ritonavir with respect to the time to sustained clinical recovery, with fewer safety concerns. (Funded by Vigonvita Life Sciences and others; ClinicalTrials.gov number, NCT05341609; Chinese Clinical Trial Registry number, ChiCTR2200057856.).

Indexed as

Antiviral AgentsCOVID-19COVID-19 Drug TreatmentAdenosineAdministration, OralAdultDisease ProgressionDrug CombinationsHumansLactamsLeucineNitrilesProlineRitonavirSARS-CoV-2Single-Blind MethodAdenosineAntiviral AgentsDrug CombinationsGS-621763LactamsLeucinenirmatrelvirnirmatrelvir and ritonavir drug combinationNitrilesProlineRitonavir

Identifiers

PMID36577095
PMCPMC9812289
OpenAlexW4313278416

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.