Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04342728
Other study ID # IRB 20-361
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Terminated NCT04558125 - Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism Phase 4
Recruiting NCT04410510 - P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19 Phase 2/Phase 3
Active, not recruiting NCT04420676 - Synbiotic Therapy of Gastrointestinal Symptoms During Covid-19 Infection N/A
Completed NCT04419025 - Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease Phase 2
Completed NCT04425317 - Detection of SARS-CoV-2 in Follicular Fluid and Cumulus-oocyte-complexes in COVID-19 Patients N/A
Completed NCT04395911 - Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections N/A
Withdrawn NCT04456426 - Characteristics of Patients With COVID-19 in Meta State, Colombia
Completed NCT04526769 - Detecting SARS-CoV-2 in Tears
Suspended NCT04385771 - Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation N/A
Completed NCT04425720 - Use of Remote Monitoring for COVID-19 Patient N/A
Completed NCT04419610 - RAS and Coagulopathy in COVID19 Early Phase 1
Completed NCT04546581 - Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC) Phase 3
Completed NCT04435327 - Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19)
Terminated NCT04530448 - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization Phase 4
Not yet recruiting NCT04524156 - COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2 N/A
Completed NCT04441710 - Caregiver Serological Monitoring Extended Secondarily to Patients With the SARS-CoV-2 Coronavirus
Completed NCT04357834 - WAVE. Wearable-based COVID-19 Markers for Prediction of Clinical Trajectories
Not yet recruiting NCT04392427 - New Antiviral Drugs for Treatment of COVID-19 Phase 3
Terminated NCT04614025 - Open-label Multicenter Study to Evaluate the Efficacy of PLX-PAD for the Treatment of COVID-19 Phase 2
Completed NCT04402957 - LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19) Phase 2