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

• Status: Completed
• Trial end date: 2021-02-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Francis Hospital, New York
• Treatments: Azithromycin; Hydroxychloroquine; Zinc Sulfate

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