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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-08

Study Completion Date

2021-02-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Study of Quadruple Therapy Zinc, Quercetin, Bromelain and Vitamin C on the Clinical Outcomes of Patients Infected With COVID-19

NCT04468139

Covid-19

UNKNOWN PHASE4

Dietary Supplements for COVID-19

NCT04780061

Covid19

TERMINATED PHASE3

Pharmacologic Ascorbic Acid as an Activator of Lymphocyte Signaling for COVID-19 Treatment

NCT04363216

COVID-19

UNKNOWN PHASE2

The Role of Resistant Starch in COVID-19 Infection

NCT04342689

COVID-19

TERMINATED PHASE2/PHASE3

Anti-inflammatory/Antioxidant Oral Nutrition Supplementation in COVID-19

NCT04323228

COVID-19

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID Corona Virus Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ascorbic Acid

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

Group Type ACTIVE_COMPARATOR

Ascorbic Acid

Intervention Type DIETARY_SUPPLEMENT

Readily available marketed open label ascorbic acid

Zinc Gluconate

50 mg of zinc gluconate to be taken daily at bedtime

Group Type ACTIVE_COMPARATOR

Zinc Gluconate

Intervention Type DIETARY_SUPPLEMENT

Readily available marketed open label zinc gluconate

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.

Group Type ACTIVE_COMPARATOR

Ascorbic Acid and Zinc Gluconate

Intervention Type DIETARY_SUPPLEMENT

Readily available marketed open label ascorbic acid and zinc gluconate

Standard of Care

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

Group Type OTHER

Standard of Care

Intervention Type OTHER

Readily available prescribed medications/ supplements- None study supplements

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ascorbic Acid

Readily available marketed open label ascorbic acid

Intervention Type DIETARY_SUPPLEMENT

Zinc Gluconate

Readily available marketed open label zinc gluconate

Intervention Type DIETARY_SUPPLEMENT

Ascorbic Acid and Zinc Gluconate

Readily available marketed open label ascorbic acid and zinc gluconate

Intervention Type DIETARY_SUPPLEMENT

Standard of Care

Readily available prescribed medications/ supplements- None study supplements

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vitamin C Zinc Vitamin C and Zinc Standard prescribed medications/ supplements

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No