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

The Cleveland Clinic214 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

214

Conditions

COVID Corona Virus Infection

Interventions

Ascorbic AcidDIETARY_SUPPLEMENT

Readily available marketed open label ascorbic acid

Zinc GluconateDIETARY_SUPPLEMENT

Readily available marketed open label zinc gluconate

Ascorbic Acid and Zinc GluconateDIETARY_SUPPLEMENT

Readily available marketed open label ascorbic acid and zinc gluconate

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Cleveland Clinic

Weston, Florida, United States

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: 28 days

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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