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

COVID Clinical Trial

— COVIDAtoZ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342728
• Other study ID #: IRB 20-361
• Status: Completed
• Phase: N/A
• Start date: April 8, 2020
• Est. completion date: February 11, 2021

Study information

• Verified date: February 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: February 11, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID
• Infection
• Severe Acute Respiratory Syndrome

Intervention

Dietary Supplement:
• Ascorbic Acid
Readily available marketed open label ascorbic acid
• Zinc Gluconate
Readily available marketed open label zinc gluconate
• Ascorbic Acid and Zinc Gluconate
Readily available marketed open label ascorbic acid and zinc gluconate

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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Cleveland Clinic	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days
Secondary	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	28 days
Secondary	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	28 days
Secondary	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	28 days
Secondary	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.	28 days
Secondary	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.	28 days
Secondary	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.	28 days
Secondary	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.	28 days
Secondary	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.	28 days
Secondary	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 .	28 days
Secondary	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.	28 days
Secondary	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.	28 days
Secondary	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.	28 days
Secondary	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.	5 days
Secondary	Hospitalizations	Differences in hospitalization events between the study arms	28 days
Secondary	Severity of Symptoms	Differences in severity of symptoms between study arms	28 days
Secondary	Adjunctive Medications	Differences in number of patients who were prescribed adjunctive medications for their diagnosis between study arms	28 days
Secondary	Supplementation Side Effects	Differences in number of patients in study arms who experienced side effects from the supplements.	28 days