Skip to main content
OpenTrials
Completed

NCT Number: NCT04621461

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Francis Hospital - The Heart Center

Roslyn, New York, 11576, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to read and understand informed consent.
  • High initial clinical suspicion by physician based on signs and symptoms (fever, cough, myalgias, fatigue, shortness of breath) followed by confirmation of COVID-19 diagnosis
  • Any gender
  • Age 60 years and older
  • Age 30-59 years with one or more of the following:
  • abnormal lung exam
  • abnormal oxygen saturation <95%
  • abnormal Chest X-ray or chest CT
  • persistent fever >100.4 degrees Fahrenheit
  • one of the following co-morbidities: hypertension, diabetes mellitus, history of coronary artery disease, chronic kidney disease (CKD), asthma, COPD, current or former smoker, or morbid obesity (Body Mass Index ≥35)

Exclusion criteria

  • Severe COVID-19 requiring admission for inpatient treatment
  • Need for any oxygen supplementation
  • Need for mechanical ventilatory support
  • History of oxygen supplementation dependency
  • History of cancer with ongoing chemotherapy or radiation therapy
  • Known hypersensitivity to zinc
  • Severe renal disease: Glomerular Filtration Rate <30ml/min

Treatment and study plan

Zinc Sulfate 220 MG

Dietary Supplement

220mg once daily for 5 days

Placebo

Drug

Once daily for 5 days

Primary outcomes

  1. 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

  2. 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

  3. Number of participants on a ventilator

    Time frame: 30 days

    If placed on ventilator, number of days on a ventilator

Secondary outcomes

  1. All-cause mortality

    Time frame: Up to 30 days

    Total number of deaths in the cohort.

  2. 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.

  3. 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)

Sponsors and collaborators

Lead sponsor

St. Francis Hospital, New York

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2020
Registry last updated
Feb 11, 2021

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.

Published trials that share one or more normalized conditions with this study.