Coronavirus Disease-2019 Clinical Trial Case Studies Within the Biotechnology and Clinical Research Organizations Industry

Authors

  • Melanie K. Pearce Brock University, Niagara Region, 1812 Sir Isaac Brock Way, St. Catharines, ON, L2S 3A1, Canada
  • Nathanael E. Hughes George Clinical,The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA

DOI:

https://doi.org/10.17140/CTPOJ-4-118

Abstract

On March 11th, 2020 the World Health Organization (WHO) declared the novel coronavirus disease-2019 (COVID-19) outbreak a global pandemic. Coronaviruses are non-segmented positive-sense ribonucleic acid (RNA) viruses in the Coronaviridae family, which typically affects the respiratory, gastrointestinal, hepatic and neurologic systems. Under Food and Drug Administration (FDA) expanded access programs and federal emergency guidelines, COVID-19 clinical trials have been some of the most successful trials to date. However, significant challenges have been presented for both Clinical Research Organizations (CROs) and the sponsoring companies, as a result of the COVID-19 pandemic.

References

Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, et al. Risk factors associated with acute respiratory distress syndrome and death in patients with coronavirus disease 2019 pneumonia in Wuhan, Chi-na. JAMA Intern Med. 2020; 180(7): 934-943. doi: 10.1001/jamain-ternmed.2020.0994

Kant S, Menez SP, Hanouneh M, Fine DM, Crews DC, Brennan DC, et al. The Covid-19 nephrology compendium: AKI, CKD, ESKD and transplantation. BMC Nephrol. 2020; 21(1): 449. doi: 10.1186/s12882-020-02112-0

Abelson R, Fink S, Kulish N, Thomas K. An overlooked, possi-bly fatal coronavirus crisis: A dire need for kidney dialysis. The New York Times. Published April 18, 2020. Web site. https://www.ny-times.com/2020/04/18/health/kidney-dialysis-coronavirus.html. Accessed November 22, 2020.

Devaux CA, Rolain J-M, Raoult D. ACE2 receptor polymor-phism: Susceptibility to SARS-CoV-2, hypertension, multi-organ failure, and COVID-19 disease outcome. J Microbiol Immunol Infect. 2020; 53(3): 425-435. doi: 10.1016/j.jmii.2020.04.015

Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19. Web site. https://clinicaltrials.gov/ct2/ show/NCT04351152. Accessed November 22, 2020.

Rob G. DUR-928 in Subjects With SARS-CoV-2 With Acute Liver or Kidney Injury. Web site. https://clinicaltrials.gov/ct2/ show/NCT04447404. Accessed November 22, 2020.

Mohammadi M, Meskini M, do Nascimento Pinto AL. Novel coronavirus (COVID-19) overview. J Public Health (Berl). 2020. doi: 10.1007/s10389-020-01258-3

Kim WC, Mauborgne R. Blue ocean strategy: How to create uncontested market space and make the competition irrelevant. Brighton, MA, USA: Harvard Business School Press; 2004.

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Published

2021-01-22

How to Cite

Melanie K. Pearce, & Nathanael E. Hughes. (2021). Coronavirus Disease-2019 Clinical Trial Case Studies Within the Biotechnology and Clinical Research Organizations Industry. Clinical Trials and Practice – Open Journal, 4(1), 10–12. https://doi.org/10.17140/CTPOJ-4-118

Issue

Vol. 4 No. 1 (2021): Volume 4 Issue 1 2021

Section

Articles

License

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

All content published in Clinical Trials and Practice – Open Journal (CTP) is licensed under the Creative Commons Attribution 4.0 International License (CC BY 4.0). This license allows anyone to copy, distribute, transmit, and adapt the work — including for commercial purposes — provided appropriate credit is given to the original author(s) and source.