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Trial record 2 of 7 for:    Coronavirus Vitamin C

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342728
Recruitment Status : Enrolling by invitation
First Posted : April 13, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Milind Desai, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
COVID Corona Virus Infection Dietary Supplement: Ascorbic Acid Dietary Supplement: Zinc Gluconate Dietary Supplement: Ascorbic Acid and Zinc Gluconate Other: Standard of Care Not Applicable

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 4 basic questions on illness severity.They will stop filling out their daily questions once they reach 0 for all categories or they reach the end of the 28 day study period. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Coronavirus Disease 2019- Using Ascorbic Acid and Zinc Supplementation (COVIDAtoZ) Research Study A Randomized, Open Label Single Center Study
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : April 30, 2021


Arm Intervention/treatment
Active Comparator: Ascorbic Acid
8000 mg of ascorbic acid divided into 2-3 doses/day with food.
Dietary Supplement: Ascorbic Acid
Readily available marketed open label ascorbic acid
Other Name: Vitamin C

Active Comparator: Zinc Gluconate
50 mg of zinc gluconate to be taken daily at bedtime
Dietary Supplement: Zinc Gluconate
Readily available marketed open label zinc gluconate
Other Name: Zinc

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

Standard of Care
Standard of care medications only as prescribed by patient's physician.
Other: Standard of Care
Readily available prescribed medications/ supplements- None study supplements
Other Name: Standard prescribed medications/ supplements




Primary Outcome Measures :
  1. Symptom Reduction [ Time Frame: 28 days ]
    Outpatients who test positive for the Coronavirus 2019; number of days required in which they reach a 50 percent reduction in the cumulative 0-12 score 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; 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. Each patient will have a composite score ranging from 0-12/day


Secondary Outcome Measures :
  1. Symptom Resolution: Fever [ Time Frame: 28 days ]
    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

  2. Symptom Resolution: Cough [ Time Frame: 28 days ]
    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

  3. Symptom Resolution: Shortness of Breath [ Time Frame: 28 days ]
    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

  4. Symptom Resolution: Fatigue [ Time Frame: 28 days ]
    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.

  5. Day 5 Symptoms [ Time Frame: 5 days ]
    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.

  6. Hospitalizations [ Time Frame: 28 days ]
    Differences in hospitalization events between the study arms

  7. Severity of Symptoms [ Time Frame: 28 days ]
    Differences in severity of symptoms between study arms

  8. Adjunctive Medications [ Time Frame: 28 days ]
    Differences in number of patients who were prescribed adjunctive medications for their diagnosis between study arms

  9. Supplementation Side Effects [ Time Frame: 28 days ]
    Differences in number of patients in study arms who experienced side effects from the supplements.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients ≥ 18 years presenting to Cleveland Clinic Health System in Northeast Ohio and Florida who test positive for COVID-19
  • 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 CKD (Chronic kidney disease)
  • Advanced liver disease awaiting transplant
  • History of Calcium Oxalate kidney stones.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342728


Locations
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United States, Florida
Cleveland Clinic
Weston, Florida, United States, 33331
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Milind Desai, M. D. The Cleveland Clinic
Principal Investigator: Suma Thomas The Cleveland Clinic
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Responsible Party: Milind Desai, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04342728    
Other Study ID Numbers: IRB 20-361
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Milind Desai, The Cleveland Clinic:
COVID-19
Viral Infection
Infection
Coronavirus-19
Ascorbic Acid
Zinc Gluconate
Additional relevant MeSH terms:
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Coronavirus Infections
Infection
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Vitamins
Ascorbic Acid
Zinc
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents