Clinical trial NCT04621461: Placebo Controlled Trial to Evaluate Zinc for the Treatment of COVID-19 in the Outpatient Setting
Official title: A Randomized, Placebo-Controlled Study Evaluating the Efficacy of Zinc for the Treatment of COVID-19 in the Outpatient Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Corona Virus Infection
Keywords: COVID-19
Zinc
Lead sponsor: St. Francis Hospital, New York
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 3
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants hospitalized and/or requiring repeat emergency room visits
timeFrame: 21 days
measure: Number of participants admitted to the Intensive care unit (ICU)
timeFrame: 30 days
measure: Number of participants on a ventilator
timeFrame: 30 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: Up to 30 days
measure: Time to resolution of COVID-19 symptoms
timeFrame: Evaluated at day 2, 6, day 14, and day 21
measure: Severity of symptoms
timeFrame: Evaluated at day 2, 6, day 14, and day 21
Other outcomes:
Locations:
city: Roslyn
country: United States
facility: St. Francis Hospital - The Heart Center
state: New York
Study officials:
affiliation: St. Francis Hospital - The Heart Center
name: Avni Thakore, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: te Velthuis AJ, van den Worm SH, Sims AC, Baric RS, Snijder EJ, van Hemert MJ. Zn(2+) inhibits coronavirus and arterivirus RNA polymerase activity in vitro and zinc ionophores block the replication of these viruses in cell culture. PLoS Pathog. 2010 Nov 4;6(11):e1001176. doi: 10.1371/journal.ppat.1001176.
citation: Singh M, Das RR. Zinc for the common cold. Cochrane Database Syst Rev. 2013 Jun 18;(6):CD001364. doi: 10.1002/14651858.CD001364.pub4.
citation: Bao S, Knoell DL. Zinc modulates airway epithelium susceptibility to death receptor-mediated apoptosis. Am J Physiol Lung Cell Mol Physiol. 2006 Mar;290(3):L433-41. doi: 10.1152/ajplung.00341.2005. Epub 2005 Nov 11.