COVIDCOVIDAtoZNCT04342728
Coronavirus 2019 (COVID-19)- Using Ascorbic Acid and Zinc Supplementation
A study testing Ascorbic Acid, Zinc Gluconate and Ascorbic Acid and Zinc Gluconate in people with COVID and Corona Virus Infection, run by The Cleveland Clinic at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Corona Virus Infection
- What is being tested?
- Ascorbic Acid, Zinc Gluconate and Ascorbic Acid and Zinc Gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Apr 2020to 11 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
- have had previous sterilization, or
- are perimenopausal (less than 1 year) who have a negative pregnancy test, or
- women of childbearing potential who do not meet the above and have a negative pregnancy test.
Who cannot join
- 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.
Show all 10Show fewer
- Lactating Women
- End stage kidney disease
- Advanced liver disease awaiting transplant
- History of Calcium Oxalate kidney stones.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Cleveland Clinic
Weston, Florida, 33331
About this study
Official title: Coronavirus Disease 2019- Using Ascorbic Acid and Zinc Supplementation (COVIDAtoZ) Research Study A Randomized, Open Label Single Center Study
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.
Read the detailed description
We aim to see whether ascorbic acid and zinc gluconate which has limited side effect profile and is readily available over the counter can decrease the duration of symptoms seen in patients with new diagnosis of COVID-2019. A secondary purpose is to see whether Zinc and/or Ascorbic acid supplementation can prevent progression of the severe manifestations of the disease including development of dyspnea and acute respiratory distress syndrome which may require hospitalization, mechanical ventilation, and or lead to death.
This is a single-center, prospective, randomized study which plans to enroll 520 patients with a principal diagnosis of COVID-2019, managed in an outpatient setting, who presented after being sent by a healthcare provider to get tested and receive a PCR (Polymerase Chain Reaction) -assay based confirmed diagnosis of the disease. All patients who agree to participate in the study will answer a baseline questionnaire about their symptoms at the time of inclusion. Patients will then be randomized to one of 4 study arms. Patients in Arm A (n=130) will receive vitamin C (to be taken divided over 2-3 times a day with meals), patients in Arm B (n=130) will receive zinc gluconate to be taken at bedtime, patients in Arm C (n=130) will receive both vitamin C (to be taken divided over 2-3 times a day with meals) and zinc gluconate (taken at bedtime). Patients in arms A, B and C will take study supplements daily for 10 days. Patients in Arm D (n=130) will not receive any of the study medications and continue on standard of care. Patients will then track their symptoms daily from day 0 to day 28 answering 12 basic questions on illness severity.They will stop filling out their daily questions once they reach reach the end of the 28 day study period or at time of hospitalization; whichever comes first . Study team members will call patients at days 7, 14, 21, and 28 of the study period to assess need for hospitalization, ER visit, or additional medications prescribed by a healthcare provider, and any side effects from the supplements that the patient could have experienced.
- Conditions
- COVID, Corona Virus Infection
- Being tested
- Ascorbic Acid, Zinc Gluconate, Ascorbic Acid and Zinc Gluconate, Standard of Care
- Keywords
- COVID-19, Viral Infection, Infection, Coronavirus-19, Ascorbic Acid, Zinc Gluconate
- Medical subject headings
- Coronavirus Infections, COVID-19, Virus Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDietary supplement
Also called Vitamin C
Readily available marketed open label ascorbic acid
Zinc GluconateDietary supplement
Also called Zinc
Readily available marketed open label zinc gluconate
Ascorbic Acid and Zinc GluconateDietary supplement
Also called Vitamin C and Zinc
Readily available marketed open label ascorbic acid and zinc gluconate
Standard of CareOther
Also called Standard prescribed medications/ supplements
Readily available prescribed medications/ supplements- None study supplements
| Study group | Role | What they receive |
|---|---|---|
| Ascorbic Acid | Active comparator | 8000 mg of ascorbic acid divided into 2-3 doses/day with food. Receives: Dietary Supplement: Ascorbic Acid |
| Zinc Gluconate | Active comparator | 50 mg of zinc gluconate to be taken daily at bedtime Receives: Dietary Supplement: Zinc Gluconate |
| Ascorbic Acid and Zinc Gluconate | Active comparator | 8000 mg of ascorbic acid divided into 2-3 doses/day with food and 50 mg of zinc gluconate to be taken daily at bedtime. Receives: Dietary Supplement: Ascorbic Acid and Zinc Gluconate |
| Standard of Care | Other | Standard of care medications only as prescribed by patient's physician. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (17)
Symptom Resolution: Fever
The number of days required to reach a score of 0 from the symptom category of fever based on a 0-3 scale: 0 = ≤98.6, 1 = >98.6- 100.6, 2 = > 100.6 - 102.6, 3 = >102.6
Measured: 28 days
Symptom Resolution: Cough
The number of days required to reach a score of 0 from the symptom category of cough based on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe
Measured: 28 days
Symptom Resolution: Shortness of Breath
The number of days required to reach a score of 0 from the symptom category of shortness of breath based on a 0-3 scale: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = with walking on flat surface 3 = short of breath with getting dressed or daily activities
Measured: 28 days
Symptom Resolution: Fatigue
The number of days required to reach a score of 0 from the symptom category of fatigue based on a 0-3 scale: 1=mild fatigue, 2=moderate fatigue, 3=severe fatigue.
Measured: 28 days
Symptom Resolution: Muscle/body aches
The number of days required to reach a score of 0 from the symptom category of muscle/body aches based on a 0-3 scale: 1=mild muscle/body aches, 2=moderate muscle/body aches , 3=severe muscle/body aches.
Measured: 28 days
Symptom Resolution: Headache
The number of days required to reach a score of 0 from the symptom category of headache based on a 0-3 scale: 1=mild headache, 2=moderate headache, 3=severe headache.
Measured: 28 days
Symptom Resolution: New loss of taste
The number of days required to reach a score of 0 from the symptom category of new loss of taste based on a 0-3 scale: 1=mild loss of taste, 2=moderate loss of taste, 3=severe loss of taste.
Measured: 28 days
Symptom Resolution: New loss of smell
The number of days required to reach a score of 0 from the symptom category of new loss of smell based on a 0-3 scale: 1=mild loss of smell, 2=moderate loss of smell, 3=severe loss of smell.
Measured: 28 days
Symptom Resolution: Congestion/ runny nose
The number of days required to reach a score of 0 from the symptom category of congestion/runny nose on a 0-3 scale: 1=mild congestion/runny nose , 2=moderate congestion/runny nose , 3=severe congestion/runny nose .
Measured: 28 days
Symptom Resolution: Nausea
The number of days required to reach a score of 0 from the symptom category of nausea on a 0-3 scale: 1=mild nausea, 2=moderate nausea, 3=severe nausea.
Measured: 28 days
Symptom Resolution: Vomiting
The number of days required to reach a score of 0 from the symptom category of vomiting on a 0-3 scale: 1=mild vomiting, 2=moderate vomiting, 3=severe vomiting.
Measured: 28 days
Symptom Resolution: Diarrhea
The number of days required to reach a score of 0 from the symptom category of diarrhea on a 0-3 scale: 1=mild diarrhea, 2=moderate diarrhea, 3=severe diarrhea.
Measured: 28 days
Day 5 Symptoms
Total symptom composite score at day 5 of study supplementation: Symptom categories of fever based on a 0-3 scale: 0 = ≤98.6, 1 = >98.6- 100.6, 2 = > 100.6 - 102.6, 3 = >102; Cough on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe; Shortness of Breath on a 0-3: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = with walking on flat surface 3 = short of breath with getting dressed or daily activities; and Fatigue on a 0-3 scale: 0 = No fatigue/energetic, 1=mild fatigue, 2=moderate fatigue, 3=severe fatigue.
Measured: 5 days
Hospitalizations
Differences in hospitalization events between the study arms
Measured: 28 days
Severity of Symptoms
Differences in severity of symptoms between study arms
Measured: 28 days
Adjunctive Medications
Differences in number of patients who were prescribed adjunctive medications for their diagnosis between study arms
Measured: 28 days
Supplementation Side Effects
Differences in number of patients in study arms who experienced side effects from the supplements.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start8 Apr 2020
- Primary completion30 Dec 2020
- Study completion11 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- A single-center, prospective, open label four arm study (1. Zinc only 2. Zinc and ascorbic acid 3. Ascorbic acid only 4. Standard of care.
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milind Desai, The Cleveland Clinic
- Investigators
- Milind Desai, M. D., Principal investigator, The Cleveland ClinicSuma Thomas, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342728
- Sponsor's protocol ID
- IRB 20-361
- Acronym
- COVIDAtoZ
- Status last verified
- Feb 2021
- First submitted
- 8 Apr 2020
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36062970O'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.
PubMed 34291813Thomas 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.
PubMed 33576820
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronavirus Disease 2019- Using Ascorbic Acid and Zinc Supplementation (COVIDAtoZ) Research Study A Randomized, Open Label Single Center Study
- ClinicalTrials.gov ID
- NCT04342728
- Acronym / sponsor ID
- COVIDAtoZ / IRB 20-361
- Conditions
- COVID, Corona Virus Infection
- Keywords
- COVID-19, Viral Infection, Infection, Coronavirus-19, Ascorbic Acid, Zinc Gluconate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We aim to see whether ascorbic acid and zinc gluconate which has limited side effect profile and is readily available over the counter can decrease the duration of symptoms seen in patients with new diagnosis of COVID-2019. A secondary purpose is to see whether Zinc and/or Ascorbic acid supplementation can prevent progression of the severe manifestations of the disease including development of dyspnea and acute respiratory distress syndrome which may require hospitalization, mechanical ventilation, and or lead to death.
This is a single-center, prospective, randomized study which plans to enroll 520 patients with a principal diagnosis of COVID-2019, managed in an outpatient setting, who presented after being sent by a healthcare provider to get tested and receive a PCR (Polymerase Chain Reaction) -assay based confirmed diagnosis of the disease. All patients who agree to participate in the study will answer a baseline questionnaire about their symptoms at the time of inclusion. Patients will then be randomized to one of 4 study arms. Patients in Arm A (n=130) will receive vitamin C (to be taken divided over 2-3 times a day with meals), patients in Arm B (n=130) will receive zinc gluconate to be taken at bedtime, patients in Arm C (n=130) will receive both vitamin C (to be taken divided over 2-3 times a day with meals) and zinc gluconate (taken at bedtime). Patients in arms A, B and C will take study supplements daily for 10 days. Patients in Arm D (n=130) will not receive any of the study medications and continue on standard of care. Patients will then track their symptoms daily from day 0 to day 28 answering 12 basic questions on illness severity.They will stop filling out their daily questions once they reach reach the end of the 28 day study period or at time of hospitalization; whichever comes first . Study team members will call patients at days 7, 14, 21, and 28 of the study period to assess need for hospitalization, ER visit, or additional medications prescribed by a healthcare provider, and any side effects from the supplements that the patient could have experienced.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A single-center, prospective, open label four arm study (1. Zinc only 2. Zinc and ascorbic acid 3. Ascorbic acid only 4. Standard of care.
| Arm | Type | Receives |
|---|---|---|
| Ascorbic Acid | Active comparator | Dietary Supplement: Ascorbic Acid8000 mg of ascorbic acid divided into 2-3 doses/day with food. |
| Zinc Gluconate | Active comparator | Dietary Supplement: Zinc Gluconate50 mg of zinc gluconate to be taken daily at bedtime |
| Ascorbic Acid and Zinc Gluconate | Active comparator | Dietary Supplement: Ascorbic Acid and Zinc Gluconate8000 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 | Other | Other: Standard of CareStandard of care medications only as prescribed by patient's physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
- have had a menstrual period within the past 30 days, or
- have had previous sterilization, or
- are perimenopausal (less than 1 year) who have a negative pregnancy test, or
- women of childbearing potential who do not meet the above and have a negative pregnancy test.
Key exclusion criteria (10 listed)
- Patients who are found to be positive during hospitalization
- Patients who reside outside Ohio or Florida.
- Pregnant women:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic AcidAlso: Vitamin CReadily available marketed open label ascorbic acid | Dietary supplement | Ascorbic Acid |
| Zinc GluconateAlso: ZincReadily available marketed open label zinc gluconate | Dietary supplement | Zinc Gluconate |
| Ascorbic Acid and Zinc GluconateAlso: Vitamin C and ZincReadily available marketed open label ascorbic acid and zinc gluconate | Dietary supplement | Ascorbic Acid and Zinc Gluconate |
| Standard of CareAlso: Standard prescribed medications/ supplementsReadily available prescribed medications/ supplements- None study supplements | Other | Standard of Care |
Primary outcome
Symptom Reduction
Time frame: 28 days
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
17 secondary outcomes
Symptom Resolution: Fever
Time frame: 28 days
Symptom Resolution: Cough
Time frame: 28 days
Symptom Resolution: Shortness of Breath
Time frame: 28 days
Symptom Resolution: Fatigue
Time frame: 28 days
Symptom Resolution: Muscle/body aches
Time frame: 28 days
Symptom Resolution: Headache
Time frame: 28 days
Symptom Resolution: New loss of taste
Time frame: 28 days
Symptom Resolution: New loss of smell
Time frame: 28 days
Symptom Resolution: Congestion/ runny nose
Time frame: 28 days
Symptom Resolution: Nausea
Time frame: 28 days
Symptom Resolution: Vomiting
Time frame: 28 days
Symptom Resolution: Diarrhea
Time frame: 28 days
Day 5 Symptoms
Time frame: 5 days
Hospitalizations
Time frame: 28 days
Severity of Symptoms
Time frame: 28 days
Adjunctive Medications
Time frame: 28 days
Supplementation Side Effects
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Derived from this study: PubMed 36062970O'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.
- Derived from this study: PubMed 34291813O'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.
- Derived from this study: PubMed 33576820Thomas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milind Desai, M. D. principal investigator
The Cleveland Clinic
Suma Thomas principal investigator
The Cleveland Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ascorbic Acid, Zinc Gluconate and Ascorbic Acid and Zinc Gluconate in people with COVID and Corona Virus Infection, run by The Cleveland Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Reduction (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04342728, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.