Efficacy and safety of proxalutamide (GT0918) in severe or critically ill patients with COVID-19: study protocol for a prospective, open-label, single-arm, single-center exploratory trial

doi:10.1186/s40360-023-00678-7

. 2023 Jun 15;24(1):38.

doi: 10.1186/s40360-023-00678-7.

Efficacy and safety of proxalutamide (GT0918) in severe or critically ill patients with COVID-19: study protocol for a prospective, open-label, single-arm, single-center exploratory trial

Dawei Yang^#^{1

2

3}, Minjie Ju^#⁴, Hao Wang^#⁵, Yichen Jia⁶, Xiaodan Wang^{1

2

3}, Hao Fang^{7

8}, Jia Fan^{9

10

11}

Affiliations

¹ Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China.
² Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, China.
³ Shanghai Engineer & Technology Research Center of Internet of Things for Respiratory Medicine, Shanghai, China.
⁴ Department of Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China.
⁵ Department of Thoracic Surgery, Zhongshan Hospital Fudan University, Shanghai, China.
⁶ Department of Urology, Zhongshan Hospital Fudan University, Shanghai, China.
⁷ Department of Anesthesiology, Zhongshan Hospital Fudan University, Shanghai, China. fang.hao@zs-hospital.sh.cn.
⁸ Department of Anesthesiology, Minhang Hospital, Fudan University, Shanghai, China. fang.hao@zs-hospital.sh.cn.
⁹ Department of Liver Surgery and Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China. fan.jia@zs-hospital.sh.cn.
¹⁰ Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education，Fudan University, Shanghai, China. fan.jia@zs-hospital.sh.cn.
¹¹ Key Laboratory of Medical Epigenetics and Metabolism, Institutes of Biomedical Sciences, Fudan University, Shanghai, China. fan.jia@zs-hospital.sh.cn.

^# Contributed equally.

PMID: 37322522
PMCID: PMC10268455
DOI: 10.1186/s40360-023-00678-7

Efficacy and safety of proxalutamide (GT0918) in severe or critically ill patients with COVID-19: study protocol for a prospective, open-label, single-arm, single-center exploratory trial

Dawei Yang et al. BMC Pharmacol Toxicol. 2023.

. 2023 Jun 15;24(1):38.

doi: 10.1186/s40360-023-00678-7.

Authors

Dawei Yang^#^{1

2

3}, Minjie Ju^#⁴, Hao Wang^#⁵, Yichen Jia⁶, Xiaodan Wang^{1

2

3}, Hao Fang^{7

8}, Jia Fan^{9

10

11}

Affiliations

¹ Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China.
² Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, China.
³ Shanghai Engineer & Technology Research Center of Internet of Things for Respiratory Medicine, Shanghai, China.
⁴ Department of Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China.
⁵ Department of Thoracic Surgery, Zhongshan Hospital Fudan University, Shanghai, China.
⁶ Department of Urology, Zhongshan Hospital Fudan University, Shanghai, China.
⁷ Department of Anesthesiology, Zhongshan Hospital Fudan University, Shanghai, China. fang.hao@zs-hospital.sh.cn.
⁸ Department of Anesthesiology, Minhang Hospital, Fudan University, Shanghai, China. fang.hao@zs-hospital.sh.cn.
⁹ Department of Liver Surgery and Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China. fan.jia@zs-hospital.sh.cn.
¹⁰ Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education，Fudan University, Shanghai, China. fan.jia@zs-hospital.sh.cn.
¹¹ Key Laboratory of Medical Epigenetics and Metabolism, Institutes of Biomedical Sciences, Fudan University, Shanghai, China. fan.jia@zs-hospital.sh.cn.

^# Contributed equally.

PMID: 37322522
PMCID: PMC10268455
DOI: 10.1186/s40360-023-00678-7

Abstract

Background: The rapid worldwide spread of COVID-19 has caused a global health challenge with high mortality of severe or critically ill patients with COVID-19. To date, there is no specific efficient therapeutics for severe or critically ill patients with COVID-19. It has been reported that androgen is related to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Proxalutamide as an androgen receptor antagonist has shown potential treatment effects on COVID-19 patients. Thus, this trial is designed to investigate the efficacy and safety of proxalutamide in severe or critically ill patients with COVID-19.

Methods: This single-arm, open-label, single-center prospective exploratory trial is planned to recruit 64 severe or critically ill patients with COVID-19 in China. Recruitment started on 16 May 2022 and is foreseen to end on 16 May 2023. Patients will be followed-up until 60 days or death, whichever comes first. The primary outcome is the 30-day all-cause mortality. Secondary endpoints included 60-day all-cause mortality, rate of clinical deterioration within 30 days after administration, time to sustain clinical recovery (determined using an 8-point ordinal scale), mean change in the Acute Physiology and Chronic Health Evaluation II scores, change in oxygenation index, changes in chest CT scan, percentage of patients confirmed negative for SARS-CoV-2 by nasopharyngeal swab, change in Ct values of SARS-CoV-2 and safety. Visits will be performed on days 1 (baseline), 15 or 30, 22, and 60.

Discussion: The trial is the first to investigate the efficacy and safety of proxalutamide in severe or critically ill patients with COVID-19. The findings of this study might lead to the development of better treatment for COVID-19 and provide convincing evidence regarding the efficacy and safety of proxalutamide.

Trial registration: This study was registered on 18 June 2022 at the Chinese Clinical Trial Registry (ChiCTR2200061250).

Keywords: COVID-19; Critical ill COVID-19; Proxalutamide; Severe COVID-19.

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Conflict of interest statement

The authors declare that they have no competing interests.

References

1. WHO Coronavirus (COVID-19) Dashboard. https://covid19.who.int/. Accessed 24 May 2023.
1. Gao YD, Ding M, Dong X. Risk factors for severe and critically ill COVID-19 patients: a review. Allergy. 2021;76(2):428–455. doi: 10.1111/all.14657. - DOI - PubMed
1. Yang X, Yu Y, Xu J, Shu H, Liu H, Wu Y, et al. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020;8(5):475–481. doi: 10.1016/S2213-2600(20)30079-5. - DOI - PMC - PubMed
1. Ai J, Li Y, Zhou X, Zhang W. COVID-19: treating and managing severe cases. Cell Res. 2020;30(5):370–371. doi: 10.1038/s41422-020-0329-2. - DOI - PMC - PubMed
1. Robinson PC, Liew DFL. COVID-19 therapeutics: challenges and directions for the future. Proc Natl Acad Sci USA. 2022;119(15):e2119893119. doi: 10.1073/pnas.2119893119. - DOI - PMC - PubMed

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[1] WHO Coronavirus (COVID-19) Dashboard. https://covid19.who.int/. Accessed 24 May 2023.

[2] WHO Coronavirus (COVID-19) Dashboard. https://covid19.who.int/. Accessed 24 May 2023.

[3] Gao YD, Ding M, Dong X. Risk factors for severe and critically ill COVID-19 patients: a review. Allergy. 2021;76(2):428–455. doi: 10.1111/all.14657. - DOI - PubMed

[4] Gao YD, Ding M, Dong X. Risk factors for severe and critically ill COVID-19 patients: a review. Allergy. 2021;76(2):428–455. doi: 10.1111/all.14657. - DOI - PubMed

[5] Yang X, Yu Y, Xu J, Shu H, Liu H, Wu Y, et al. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020;8(5):475–481. doi: 10.1016/S2213-2600(20)30079-5. - DOI - PMC - PubMed

[6] Yang X, Yu Y, Xu J, Shu H, Liu H, Wu Y, et al. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020;8(5):475–481. doi: 10.1016/S2213-2600(20)30079-5. - DOI - PMC - PubMed

[7] Ai J, Li Y, Zhou X, Zhang W. COVID-19: treating and managing severe cases. Cell Res. 2020;30(5):370–371. doi: 10.1038/s41422-020-0329-2. - DOI - PMC - PubMed

[8] Ai J, Li Y, Zhou X, Zhang W. COVID-19: treating and managing severe cases. Cell Res. 2020;30(5):370–371. doi: 10.1038/s41422-020-0329-2. - DOI - PMC - PubMed

[9] Robinson PC, Liew DFL. COVID-19 therapeutics: challenges and directions for the future. Proc Natl Acad Sci USA. 2022;119(15):e2119893119. doi: 10.1073/pnas.2119893119. - DOI - PMC - PubMed

[10] Robinson PC, Liew DFL. COVID-19 therapeutics: challenges and directions for the future. Proc Natl Acad Sci USA. 2022;119(15):e2119893119. doi: 10.1073/pnas.2119893119. - DOI - PMC - PubMed

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Efficacy and safety of proxalutamide (GT0918) in severe or critically ill patients with COVID-19: study protocol for a prospective, open-label, single-arm, single-center exploratory trial

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Efficacy and safety of proxalutamide (GT0918) in severe or critically ill patients with COVID-19: study protocol for a prospective, open-label, single-arm, single-center exploratory trial

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