Placebo Controlled Trial to Evaluate Zinc for the Treatment of COVID-19 in the Outpatient Setting
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|ClinicalTrials.gov Identifier: NCT04621461|
Recruitment Status : Completed
First Posted : November 9, 2020
Last Update Posted : February 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Corona Virus Infection||Dietary Supplement: Zinc Sulfate 220 MG Drug: Placebo||Phase 4|
Zinc, a micronutrient, appears to have anti-viral properties with various mechanisms of action depending on the concentration Zinc supplementation has been reviewed extensively for use in the common cold, and has been shown to reduce the duration of symptoms. In-vitro studies have shown zinc can inhibit RNA-dependent RNA polymerase (RdRP) in coronavirus, which is typically a conserved region in the viral genome. In-vitro experiments have also shown that lung epithelium in a zinc depleted state can become susceptible to apoptosis and loss of barrier function, increasing permeability, which can lead to acute respiratory distress syndrome (ARDS).
If a patient can travel to St. Francis Hospital they can have a COVID test on site at a designated St. Francis testing location. The COVID test will be resulted via a rapid Covid (Point of Care device) or at a local lab.
Patients who are unable to travel to St. Francis Hospital or one of the outpatient practices, will be allowed to enroll remotely. Patients are eligible to enroll within 72 hours of a positive Covid-19 test result. Study medications will be mailed to the patient overnight after being enrolled.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a randomized, double-blind, placebo-controlled trial to assess the efficacy of zinc in a higher risk COVID-19 positive outpatient population. Patients will randomized to zinc or placebo.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Patients will be randomized via a randomization block. Only the research coordinator will know which group the patients belong to. Placebo pills given to the patient will be similar in size and shape to zinc.|
|Official Title:||A Randomized, Placebo-Controlled Study Evaluating the Efficacy of Zinc for the Treatment of COVID-19 in the Outpatient Setting|
|Actual Study Start Date :||December 20, 2020|
|Actual Primary Completion Date :||February 8, 2021|
|Actual Study Completion Date :||February 8, 2021|
Placebo Comparator: Experimental Arm #1
Once daily for 5 days
Experimental: Experimental Arm #2
Dietary Supplement: Zinc Sulfate 220 MG
220mg once daily for 5 days
- Number of participants hospitalized and/or requiring repeat emergency room visits [ Time Frame: 21 days ]COVID-19 related complications that require the participant to be hospitalized or have an emergency room visit
- Number of participants admitted to the Intensive care unit (ICU) [ Time Frame: 30 days ]If hospitalized, number of participants admitted to the ICU, and number of days in the ICU
- Number of participants on a ventilator [ Time Frame: 30 days ]If placed on ventilator, number of days on a ventilator
- All-cause mortality [ Time Frame: Up to 30 days ]Total number of deaths in the cohort.
- Time to resolution of COVID-19 symptoms [ Time Frame: Evaluated at day 2, 6, day 14, and day 21 ]Time at which the patient is completely symptom free.
- Severity of symptoms [ Time Frame: Evaluated at day 2, 6, day 14, and day 21 ]Scored by the participant for feverishness, sore throat, cough, shortness of breath, myalgias. (0 =none; 1 = mild; 2 = moderate; 3 = severe)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621461
|United States, New York|
|St. Francis Hospital - The Heart Center|
|Roslyn, New York, United States, 11576|
|Principal Investigator:||Avni Thakore, MD||St. Francis Hospital - The Heart Center|