Design a study protocol abstract for COVID -19 (Coronavirus):

HCR 557 Assignment 3

As we all know the cases of COVID-19 have reached pandemic proportions, and the spread of the virus has affected people globally. The international medical community is working unitedly to resolve this crisis.
Read the articles below or the most current on the subject.
https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html
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https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-first-emergency-use-authorization-point-care-diagnostic
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https://www.nih.gov/news-events/news-releases/nih-clinical-trial-remdesivir-treat-covid-19-begins
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https://www.gilead.com/news-and-press/press-room/press-releases/2020/2/gilead-sciences-initiates-two-phase-3-studies-of-investigational-antiviral-remdesivir-for-the-treatment-of-covid-19
(Links to an external site.)
https://www.biospace.com/article/coronavirus-update-gilead-struggles-to-recruit-patients-for-coronavirus-study/
(Links to an external site.)

Largest Covid-19 trials studying Umifenovir or traditional Chinese medicine

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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic

Every Vaccine and Treatment in Development for COVID-19, So Far

(Links to an external site.)
https://coronavirus.jhu.edu/
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Fulton, A., Sumner, E. (April 14, 2020). Update: Key FDA Actions for COVID-19 Devices and Therapies (as of April 14). National Law Review
https://www.natlawreview.com/article/update-key-fda-actions-covid-19-devices-and-therapies-april-14
(Links to an external site.)

PART 1: (50 points)
Do a little external reading.
1. Describe the pandemic of COVID-19 in numbers. What type of studies provided the information? How are the international and national communities working together (Governmental bodies, Healthcare Providers, Scientists, Pharmaceutical industries and Financial aid)? (25 points)
2. There are challenges that would be involved in a global clinical trial (distance, language, culture, economic statuses, political, bureaucratic, ethical, educational, environmental concerns, and many more). Select 5 of these or other challenges, and write a brief paragraph each regarding clinical research with COVID-19. (25 points)

PART 2: (25 points)

Luciana Borio

(Links to an external site.)
Listen to the Tedtalk by Dr. Luciana Borio on Ebola. She mentions two hospitals – Hospital A and Hospital B. The doctors at hospital A have a different way to test the study drug than the doctors at hospital B. Let’s call the study from hospital A as study design A and the study from hospital B as study design B. Now, consider that you work for a hospital and the hospital is treating coronavirus instead of Ebola. You are required to design a study – Would you select study design A or study design B, or an alternative. Justify your answer.
Use the Tedtalk and its content as your reference.

PART 3: (75 points)
Design a study protocol abstract for COVID -19 (Coronavirus):
1.State the study objective. (5 points)
2.State the study design (prospective or retrospective, phase, randomized – nonrandomized; open – blind; multicentric national or global, safety and/or efficacy). (10 points)
3. What would be your study population (treatment naïve patients, a specific time from diagnosis, based on the severity of the disease etc)? Would there be an inclusion or exclusion criteria? If yes, list two inclusion and two exclusion criteria. If no, explain your answer. (20points)
4. State at least two study endpoints. And the tools to measure them. Also, state the tests that will be used for statistical analysis. (20 points)
5. For epidemic studies, how would you calculate the sample size? Calculate an estimated sample size for the study. If you must; use power as 80% and ⍺ as 0.05. (20 points)

Hulley S. Designing Clinical Research, 4th Published By: Lippincott Williams & Wilkins; ISBN-10: 1469840545; ISBN-13: 9781469840543
Shah, K, Wells, C and Pfeiffer, J (2017). A Clinical Trial Workbook: Material to Complement Research Education and Training LAD Custom Publishing, Inc (Edition 2) ISBN 978-0-8401-3527-8