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

NeuroTherapia, Inc.

Status: Completed

Conditions: Corona Virus Infection; COVID

Treatments: Dietary Supplement: Zinc Gluconate; Dietary Supplement: Ascorbic Acid; Dietary Supplement: Ascorbic Acid and Zinc Gluconate; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04342728

IRB 20-361

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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214 participants in 4 patient groups

Ascorbic Acid

Active Comparator group

Description:

8000 mg of ascorbic acid divided into 2-3 doses/day with food.

Treatment:

Dietary Supplement: Ascorbic Acid

Zinc Gluconate

Active Comparator group

Description:

50 mg of zinc gluconate to be taken daily at bedtime

Treatment:

Dietary Supplement: Zinc Gluconate

Ascorbic Acid and Zinc Gluconate

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Ascorbic Acid and Zinc Gluconate

Standard of Care

Other group

Description:

Standard of care medications only as prescribed by patient's physician.

Treatment:

Other: Standard of Care