Use the following study (link here) to answer the following questions below: What are the independent and dependent variables of the study?   b) Is this study experimental or observational? How can you tell? c) Is this study quantitative or qualitative? How can you tell? d) One of the primary end points/outcomes the study listed was the number of days that it took to reach a 50% reduction in symptoms as reported on a 12-Symptom scale. In Table 2, you can see that the statistical test they used to evaluate differences between groups for this end point produced a p-value of 0.97. Please provide an interpretation of this p-value, explaining what it means in terms of whether significant differences exist between the groups in the number of days it took to achieve a 50% reduction in symptoms on the 12-Symptom scale.

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Question 1: Use the following study (link here) to answer the following questions below:

  1. What are the independent and dependent variables of the study?

 

  1. b) Is this study experimental or observational? How can you tell?
  2. c) Is this study quantitative or qualitative? How can you tell?
  3. d) One of the primary end points/outcomes the study listed was the number of days that it took to reach a 50% reduction in symptoms as reported on a 12-Symptom scale. In Table 2, you can see that the statistical test they used to evaluate differences between groups for this end point produced a p-value of 0.97. Please provide an interpretation of this p-value, explaining what it means in terms of whether significant differences exist between the groups in the number of days it took to achieve a 50% reduction in symptoms on the 12-Symptom scale.
JAMA
Network Open.
Original Investigation | Public Health
Effect of High-Dose Zinc and Ascorbic Acid Supplementation vs Usual Care
on Symptom Length and Reduction Among Ambulatory Patients
With SARS-CoV-2 Infection
The COVID A to Z Randomized Clinical Trial
Suma Thomas, MD, MBA; Divyang Patel, MD, MS; Barbara Bittel, BSN, RN; Kathy Wolski, MPH; Qiuqing Wang, MS; Anirudh Kumar, MD, MS; Zachary J. Il'Giovine, MD;
Reena Mehra, MD, MS; Carla McWilliams, MD; Steve E. Nissen, MD; Milind Y. Desai, MD, MBA
Abstract
IMPORTANCE There is limited evidence regarding early treatment of novel severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) infection to mitigate symptom progression.
OBJECTIVE To examine whether high-dose zinc and/or high-dose ascorbic acid reduce the severity
or duration of symptoms compared with usual care among ambulatory patients with SARS-CoV-2
infection.
DESIGN, SETTING, AND PARTICIPANTS This multicenter, single health system randomized clinical
factorial open-label trial enrolled 214 adult patients with a diagnosis of SARS-CoV-2 infection
confirmed with a polymerase chain reaction assay who received outpatient care in sites in Ohio and
Florida. The trial was conducted from April 27, 2020, to October 14, 2020.
INTERVENTION Patients were randomized in a 1:1:1:1 allocation ratio to receive either 10 days of zinc
gluconate (50 mg), ascorbic acid (8000 mg), both agents, or standard of care.
OUTCOMES The primary end point was the number of days required to reach a 50% reduction in
symptoms, including severity of fever, cough, shortness of breath, and fatigue (rated on a 4-point
scale for each symptom). Secondary end points included days required to reach a total symptom
severity score of O, cumulative severity score at day 5, hospitalizations, deaths, adjunctive prescribed
medications, and adverse effects of the study supplements.
RESULTS A total of 214 patients were randomized, with a mean (SD) age of 45.2 (14.6) years and 132
(61.7%) women. The study was stopped for a low conditional power for benefit with no significant
difference among the 4 groups for the primary end point. Patients who received usual care without
supplementation achieved a 50% reduction in symptoms at a mean (SD) of 6.7 (4.4) days compared
with 5.5 (3.7) days for the ascorbic acid group, 5.9 (4.9) days for the zinc gluconate group, and 5.5
(3.4) days for the group receiving both (overall P = .45). There was no significant difference in
secondary outcomes among the treatment groups.
CONCLUSIONS AND RELEVANCE In this randomized clinical trial of ambulatory patients diagnosed
with SARS-CoV-2 infection, treatment with high-dose zinc gluconate, ascorbic acid, or a combination
of the 2 supplements did not significantly decrease the duration of symptoms compared with
standard of care.
TRIAL REGISTRATION Clinical Trials.gov Identifier: NCT04342728
JAMA Network Open. 2021;4(2):e210369. doi:10.1001/jamanetworkopen.2021.0369
Open Access. This is an open access article distributed under the terms of the CC-BY License.
JAMA Network Open. 2021;4(2):e210369. doi:10.1001/jamanetworkopen.2021.0369
Downloaded From: https://jamanetwork.com/ by a Samford University Library User on 03/13/2023
Key Points
Question Do high-dose zinc, high-dose
ascorbic acid, and/or a combination of
the 2 reduce the duration of symptoms
of severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2)?
CO
Findings In this randomized clinical trial
of 214 patients with confirmed SARS-
CoV-2 infection receiving outpatient
care, there was no significant difference
in the duration of symptoms among the
4 groups.
Meaning These findings suggest that
treatment with zinc, ascorbic acid, or
both does not affect SARS-CoV-2
symptoms.
+ Visual Abstract
+ Invited Commentary
+ Supplemental content
Author affiliations and article information are
listed at the end of this article.
February 12, 2021 1/10
Transcribed Image Text:JAMA Network Open. Original Investigation | Public Health Effect of High-Dose Zinc and Ascorbic Acid Supplementation vs Usual Care on Symptom Length and Reduction Among Ambulatory Patients With SARS-CoV-2 Infection The COVID A to Z Randomized Clinical Trial Suma Thomas, MD, MBA; Divyang Patel, MD, MS; Barbara Bittel, BSN, RN; Kathy Wolski, MPH; Qiuqing Wang, MS; Anirudh Kumar, MD, MS; Zachary J. Il'Giovine, MD; Reena Mehra, MD, MS; Carla McWilliams, MD; Steve E. Nissen, MD; Milind Y. Desai, MD, MBA Abstract IMPORTANCE There is limited evidence regarding early treatment of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection to mitigate symptom progression. OBJECTIVE To examine whether high-dose zinc and/or high-dose ascorbic acid reduce the severity or duration of symptoms compared with usual care among ambulatory patients with SARS-CoV-2 infection. DESIGN, SETTING, AND PARTICIPANTS This multicenter, single health system randomized clinical factorial open-label trial enrolled 214 adult patients with a diagnosis of SARS-CoV-2 infection confirmed with a polymerase chain reaction assay who received outpatient care in sites in Ohio and Florida. The trial was conducted from April 27, 2020, to October 14, 2020. INTERVENTION Patients were randomized in a 1:1:1:1 allocation ratio to receive either 10 days of zinc gluconate (50 mg), ascorbic acid (8000 mg), both agents, or standard of care. OUTCOMES The primary end point was the number of days required to reach a 50% reduction in symptoms, including severity of fever, cough, shortness of breath, and fatigue (rated on a 4-point scale for each symptom). Secondary end points included days required to reach a total symptom severity score of O, cumulative severity score at day 5, hospitalizations, deaths, adjunctive prescribed medications, and adverse effects of the study supplements. RESULTS A total of 214 patients were randomized, with a mean (SD) age of 45.2 (14.6) years and 132 (61.7%) women. The study was stopped for a low conditional power for benefit with no significant difference among the 4 groups for the primary end point. Patients who received usual care without supplementation achieved a 50% reduction in symptoms at a mean (SD) of 6.7 (4.4) days compared with 5.5 (3.7) days for the ascorbic acid group, 5.9 (4.9) days for the zinc gluconate group, and 5.5 (3.4) days for the group receiving both (overall P = .45). There was no significant difference in secondary outcomes among the treatment groups. CONCLUSIONS AND RELEVANCE In this randomized clinical trial of ambulatory patients diagnosed with SARS-CoV-2 infection, treatment with high-dose zinc gluconate, ascorbic acid, or a combination of the 2 supplements did not significantly decrease the duration of symptoms compared with standard of care. TRIAL REGISTRATION Clinical Trials.gov Identifier: NCT04342728 JAMA Network Open. 2021;4(2):e210369. doi:10.1001/jamanetworkopen.2021.0369 Open Access. This is an open access article distributed under the terms of the CC-BY License. JAMA Network Open. 2021;4(2):e210369. doi:10.1001/jamanetworkopen.2021.0369 Downloaded From: https://jamanetwork.com/ by a Samford University Library User on 03/13/2023 Key Points Question Do high-dose zinc, high-dose ascorbic acid, and/or a combination of the 2 reduce the duration of symptoms of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)? CO Findings In this randomized clinical trial of 214 patients with confirmed SARS- CoV-2 infection receiving outpatient care, there was no significant difference in the duration of symptoms among the 4 groups. Meaning These findings suggest that treatment with zinc, ascorbic acid, or both does not affect SARS-CoV-2 symptoms. + Visual Abstract + Invited Commentary + Supplemental content Author affiliations and article information are listed at the end of this article. February 12, 2021 1/10
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