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临床试验/NCT04342728
NCT04342728已完成不适用

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

The Cleveland Clinic3 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2020年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
214
试验地点
3
主要终点
Symptom Reduction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • Fever or chills
  • Shortness of breath or difficulty breathing
  • Muscle or body Aches
  • New loss of taste
  • New loss of smell
  • Congestion or runny nose
  • Women of child bearing potential:
  • have had a menstrual period within the past 30 days, or
  • have had previous sterilization, or
  • are perimenopausal (less than 1 year) who have a negative pregnancy test, or
  • women of childbearing potential who do not meet the above and have a negative pregnancy test.

排除标准

  • Patients who are found to be positive during hospitalization
  • Patients who reside outside Ohio or Florida.
  • Pregnant women:
  • Current known pregnancy
  • 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.

结局指标

主要结局

Symptom Reduction

时间窗: 28 days

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

次要结局

  • Symptom Resolution: Headache(28 days)
  • Symptom Resolution: Fatigue(28 days)
  • Symptom Resolution: New loss of taste(28 days)
  • Symptom Resolution: New loss of smell(28 days)
  • Symptom Resolution: Congestion/ runny nose(28 days)
  • Symptom Resolution: Vomiting(28 days)
  • Hospitalizations(28 days)
  • Adjunctive Medications(28 days)
  • Symptom Resolution: Muscle/body aches(28 days)
  • Symptom Resolution: Fever(28 days)
  • Symptom Resolution: Cough(28 days)
  • Symptom Resolution: Shortness of Breath(28 days)
  • Day 5 Symptoms(5 days)
  • Severity of Symptoms(28 days)
  • Symptom Resolution: Diarrhea(28 days)
  • Supplementation Side Effects(28 days)
  • Symptom Resolution: Nausea(28 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Milind Desai

Principal Investigator

The Cleveland Clinic

研究点 (3)

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