Coronavirus 2019 (COVID-19)- Using Ascorbic Acid and Zinc Supplementation
Coronavirus 2019 (COVID-19)- Using Ascorbic Acid and Zinc Supplementation
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.
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.
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.