NCT04621461

Placebo Controlled Trial to Evaluate Zinc for the Treatment of COVID-19 in the Outpatient Setting

A Randomized, Placebo-Controlled Study Evaluating the Efficacy of Zinc for the Treatment of COVID-19 in the Outpatient Setting

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: St. Francis Hospital, New York · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled trial to assess the efficacy of zinc in a higher risk COVID-19 positive outpatient population.

Detailed description

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.

Conditions

• Corona Virus Infection

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Zinc Sulfate 220 MG	220mg once daily for 5 days
DRUG	Placebo	Once daily for 5 days

Timeline

• Start date: 2020-12-20
• Primary completion: 2021-02-08
• Completion: 2021-02-08
• First posted: 2020-11-09
• Last updated: 2021-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study