A Multicenter Randomized Controlled Trial To Evaluate the Efficacy and Safety of Nelfinavir in Patients with Mild COVID-19

Author:

Miyazaki Taiga12ORCID,Hosogaya Naoki34,Fukushige Yuri3,Takemori Sachiko3,Morimoto Shinpei3,Yamamoto Hiroshi3,Hori Makoto5,Ozawa Yoshihito5,Shiko Yuki5,Inaba Yosuke5,Kurokawa Tomoya5,Hanaoka Hideki5,Iwanami Shoya6,Kim Kwangsu6,Iwami Shingo6,Watashi Koichi7,Miyazawa Ken8ORCID,Umeyama Takashi8,Yamagoe Satoshi9,Miyazaki Yoshitsugu8ORCID,Wakita Takaji10,Sumiyoshi Makoto1,Hirayama Tatsuro411ORCID,Izumikawa Koichi12,Yanagihara Katsunori13,Mukae Hiroshi4,Kawasuji Hitoshi14,Yamamoto Yoshihiro14,Tarumoto Norihito15,Ishii Hiroshi16,Ohno Hideaki17,Yatera Kazuhiro18,Kakeya Hiroshi19,Kichikawa Yoshiko20,Kato Yasuyuki21,Matsumoto Tetsuya21,Saito Makoto22ORCID,Yotsuyanagi Hiroshi22,Kohno Shigeru2

Affiliation:

1. Division of Respirology, Rheumatology, Infectious Diseases, and Neurology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan

2. Nagasaki University, Nagasaki, Japan

3. Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan

4. Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan

5. Division of Clinical Research Center, Chiba University Hospital, Chiba, Japan

6. interdisciplinary Biology Laboratory (iBLab), Division of Biological Sciences, Graduate School of Science, Nagoya University, Aichi, Japan

7. Research Center for Drug and Vaccine Development, National Institute of Infectious Diseases, Tokyo, Japan

8. Department of Fungal Infection, National Institute of Infectious Diseases, Tokyo, Japan

9. Section of Infectious Resource Coordination, Department of Research Resource, Center of Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan

10. National Institute of Infectious Diseases, Tokyo, Japan

11. Department of Pharmacotherapeutics, Nagasaki University Graduate School of Biomedical Science, Nagasaki, Japan

12. Infection Control and Education Center, Nagasaki University Hospital, Nagasaki, Japan

13. Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan

14. Department of Infectious Disease, Toyama University Hospital, Toyama, Japan

15. Department of Infectious Disease and Infection Control, Saitama Medical University Hospital, Saitama, Japan

16. Department of Respiratory Medicine, Fukuoka University Chikushi Hospital, Fukuoka, Japan

17. Department of Infectious Disease and Infection Control, Saitama Medical Center, Saitama, Japan

18. Department of Respiratory Medicine, Hospital of the University of Occupational and Environmental Health, Japan, Fukuoka, Japan

19. Department of Infection Control Science, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan

20. Division of Respiratory Medicine, Mishuku Hospital, Tokyo, Japan

21. Department of Infectious Diseases, International University of Health and Welfare Narita Hospital, Chiba, Japan

22. Department of Infectious Diseases and Applied Immunology, IMSUT Hospital of The Institute of Medical Science, The University of Tokyo, Tokyo, Japan

Abstract

The anti-HIV drug nelfinavir suppresses the replication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro . However, its efficacy in patients with COVID-19 has not been studied.

Funder

Japan Agency for Medical Research and Development

Ministry of Health, Labour and Welfare

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Cell Biology,Microbiology (medical),Genetics,General Immunology and Microbiology,Ecology,Physiology

Reference30 articles.

1. World Health Organization. 2020. Novel coronavirus (2019-nCoV): situation report vol 1. https://apps.who.int/iris/handle/10665/330760. Accessed 11 April 2022.

2. United States National Institutes of Health. Coronavirus Disease. 2019. 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov. Accessed 11 April 2022.

3. Food and Drug Administration. 2022. Fact sheet for healthcare providers: emergency use authorization for Paxlovid. https://www.fda.gov/media/155050/download.

4. Food and Drug Administration. 2021. Fact sheet for healthcare providers: emergency use authorization for Lagevrio (molnupiravir) capsules. https://www.fda.gov/media/155054/download.

5. SARS-CoV-2 Transmission From People Without COVID-19 Symptoms

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