Coronavirus 2019 (COVID-19)- Using Ascorbic Acid and Zinc Supplementation
COVIDAtoZ
Coronavirus Disease 2019- Using Ascorbic Acid and Zinc Supplementation (COVIDAtoZ) Research Study A Randomized, Open Label Single Center Study
1 other identifier
interventional
214
1 country
2
Brief Summary
The purpose of this study is to examine the impact of ascorbic acid (vitamin c) and zinc gluconate in reducing duration of symptoms in patients diagnosed with coronavirus disease 2019 (COVID-19). Patients above the age of 18 who present to the Cleveland Clinic outpatient testing and receive a positive test for COVID-19 will be invited to participate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2020
CompletedStudy Start
First participant enrolled
April 8, 2020
CompletedFirst Posted
Study publicly available on registry
April 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2021
CompletedFebruary 16, 2021
February 1, 2021
9 months
April 8, 2020
February 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptom Reduction
Number of days to reach a 50 percent reduction in the cumulative 0-36 symptom score with each symptom evaluated on a 0-3 scale. Assessed symptoms are Fever, Cough, Shortness of Breath, Fatigue, Muscle or body aches, Headache, New loss of taste, New loss of smell, Congestion or runny nose, Nausea, Vomiting, Diarrhea. Each patient will have a composite score ranging from 0-36/day
28 days
Secondary Outcomes (17)
Symptom Resolution: Fever
28 days
Symptom Resolution: Cough
28 days
Symptom Resolution: Shortness of Breath
28 days
Symptom Resolution: Fatigue
28 days
Symptom Resolution: Muscle/body aches
28 days
- +12 more secondary outcomes
Study Arms (4)
Ascorbic Acid
ACTIVE COMPARATOR8000 mg of ascorbic acid divided into 2-3 doses/day with food.
Zinc Gluconate
ACTIVE COMPARATOR50 mg of zinc gluconate to be taken daily at bedtime
Ascorbic Acid and Zinc Gluconate
ACTIVE COMPARATOR8000 mg of ascorbic acid divided into 2-3 doses/day with food and 50 mg of zinc gluconate to be taken daily at bedtime.
Standard of Care
OTHERStandard of care medications only as prescribed by patient's physician.
Interventions
Readily available marketed open label ascorbic acid
Readily available marketed open label zinc gluconate
Readily available marketed open label ascorbic acid and zinc gluconate
Readily available prescribed medications/ supplements- None study supplements
Eligibility Criteria
You may qualify if:
- Outpatients ≥ 18 years presenting to Cleveland Clinic Health System in Ohio and Florida who test positive for COVID-19 having any of the following symptoms
- Fever or chills
- Shortness of breath or difficulty breathing
- Cough
- Fatigue
- Muscle or body Aches
- Headache
- New loss of taste
- New loss of smell
- Congestion or runny nose
- Nausea
- Vomiting
- Diarrhea
- Women of child bearing potential:
- have had a menstrual period within the past 30 days, or
- +3 more criteria
You may not qualify if:
- Patients who are found to be positive during hospitalization
- Patients who reside outside Ohio or Florida.
- Pregnant women:
- Current known pregnancy
- Positive pregnancy test (women of child bearing potential who have not had previous sterilization as defined as hysterectomy or tubal ligation)
- Women of childbearing potential who do not meet the above criteria, last menstrual period greater than 30 days and have a positive pregnancy test.
- Lactating Women
- End stage kidney disease
- Advanced liver disease awaiting transplant
- History of Calcium Oxalate kidney stones.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cleveland Clinic
Weston, Florida, 33331, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (3)
O'Byrne L, Webster KE, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the treatment of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD013876. doi: 10.1002/14651858.CD013876.pub3.
PMID: 36062970DERIVEDO'Byrne L, Webster KE, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the treatment of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2021 Jul 22;7(7):CD013876. doi: 10.1002/14651858.CD013876.pub2.
PMID: 34291813DERIVEDThomas S, Patel D, Bittel B, Wolski K, Wang Q, Kumar A, Il'Giovine ZJ, Mehra R, McWilliams C, Nissen SE, Desai MY. 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. JAMA Netw Open. 2021 Feb 1;4(2):e210369. doi: 10.1001/jamanetworkopen.2021.0369.
PMID: 33576820DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Milind Desai, M. D.
The Cleveland Clinic
- PRINCIPAL INVESTIGATOR
Suma Thomas
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 8, 2020
First Posted
April 13, 2020
Study Start
April 8, 2020
Primary Completion
December 30, 2020
Study Completion
February 11, 2021
Last Updated
February 16, 2021
Record last verified: 2021-02