Official Title
Coronavirus Disease 2019- Using Ascorbic Acid and Zinc Supplementation (COVIDAtoZ) Research Study A Randomized, Open Label Single Center Study
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.

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.

Enrolling by invitation
COVID
Corona Virus Infection

Dietary Supplement: Ascorbic Acid
Readily available marketed open label ascorbic acid
Ascorbic Acid
Other Name: Vitamin C

Dietary Supplement: Zinc Gluconate
Readily available marketed open label zinc gluconate
Zinc Gluconate
Other Name: Zinc

Dietary Supplement: Ascorbic Acid and Zinc Gluconate
Readily available marketed open label ascorbic acid and zinc gluconate
Ascorbic Acid and Zinc Gluconate
Other Name: Vitamin C and Zinc

Other: Standard of Care
Readily available prescribed medications/ supplements- None study supplements
Standard of Care
Other Name: Standard prescribed medications/ supplements

Eligibility Criteria

Inclusion Criteria: - 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 1. Fever or chills 2. Shortness of breath or difficulty breathing 3. Cough 4. Fatigue 5. Muscle or body Aches 6. Headache 7. New loss of taste 8. New loss of smell 9. Congestion or runny nose 10. Nausea 11. Vomiting 12. Diarrhea

Women of child bearing potential: 1. have had a menstrual period within the past 30 days, or 2. have had previous sterilization, or 3. are perimenopausal (less than 1 year) who have a negative pregnancy test, or 4. women of childbearing potential who do not meet the above and have a negative pregnancy test.

Exclusion Criteria: - Patients who are found to be positive during hospitalization - Patients who reside outside Ohio or Florida. - Pregnant women: 1. Current known pregnancy 2. 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Cleveland Clinic
Weston, Florida, 33331

Cleveland Clinic
Cleveland, Ohio, 44195

Milind Desai, M. D.
Principal Investigator
The Cleveland Clinic

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Suma Thomas
Principal Investigator
The Cleveland Clinic

The Cleveland Clinic
NCT Number
Keywords
Covid-19
Viral Infection
Infection
Coronavirus-19
Ascorbic Acid
Zinc Gluconate
MeSH Terms
Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Vitamins
Ascorbic Acid
Zinc