St. Francis Hospital - The Heart Center
Roslyn, New York, 11576, United States
NCT Number: NCT04621461
This is a randomized, double-blind, placebo-controlled trial to assess the efficacy of zinc in a higher risk COVID-19 positive outpatient population.
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Notify Me30 year and older
All sexes
Interventional
Phase 4
Roslyn, New York, 11576, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
220mg once daily for 5 days
Once daily for 5 days
Time frame: 21 days
COVID-19 related complications that require the participant to be hospitalized or have an emergency room visit
Time frame: 30 days
If hospitalized, number of participants admitted to the ICU, and number of days in the ICU
Time frame: 30 days
If placed on ventilator, number of days on a ventilator
Time frame: Up to 30 days
Total number of deaths in the cohort.
Time frame: Evaluated at day 2, 6, day 14, and day 21
Time at which the patient is completely symptom free.
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)
St. Francis Hospital, New York
Other
A Randomized, Placebo-Controlled Study Evaluating the Efficacy of Zinc for the Treatment of COVID-19 in the Outpatient Setting
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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