1. A pilot double‐blind safety and feasibility randomized controlled trial of high‐dose intravenous zinc in hospitalized COVID‐19 patients
- Author
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Ary Serpa Neto, Christine F McDonald, John El-Khoury, Damien M Bolton, Daryl A Jones, Joseph Ischia, Rinaldo Bellomo, Jason A Trubiano, Marlon Perera, Oneel Patel, Vidyasagar Chinni, Emily J See, and Intensive Care Medicine
- Subjects
Adult ,Male ,Short Communication ,Short Communications ,Pilot Projects ,medicine.disease_cause ,Placebo ,Infusion Site ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Pharmacotherapy ,Double-Blind Method ,Randomized controlled trial ,COVID‐19 ,law ,Virology ,medicine ,Humans ,030212 general & internal medicine ,Adverse effect ,Aged ,Aged, 80 and over ,Inpatients ,Dose-Response Relationship, Drug ,SARS-CoV-2 ,business.industry ,zinc ,COVID-19 ,trial protocol ,Middle Aged ,medicine.disease ,Respiration, Artificial ,COVID-19 Drug Treatment ,Oxygen ,Increased serum zinc ,Infectious Diseases ,Anesthesia ,Injections, Intravenous ,randomized controlled trial ,Zinc deficiency ,Feasibility Studies ,Female ,030211 gastroenterology & hepatology ,Irritation ,business - Abstract
Zinc inhibits replication of the SARS‐CoV virus. We aimed to evaluate the safety, feasibility, and biological effect of administering high‐dose intravenous zinc (HDIVZn) to patients with COVID‐19. We performed a Phase IIa double‐blind, randomized controlled trial to compare HDIVZn to placebo in hospitalized patients with COVID‐19. We administered trial treatment per day for a maximum of 7 days until either death or hospital discharge. We measured zinc concentration at baseline and during treatment and observed patients for any significant side effects. For eligible patients, we randomized and administered treatment to 33 adult participants to either HDIVZn (n = 15) or placebo (n = 18). We observed no serious adverse events throughout the study for a total of 94 HDIVZn administrations. However, three participants in the HDIVZn group reported infusion site irritation. Mean serum zinc on Day 1 in the placebo, and the HDIVZn group was 6.9 ± 1.1 and 7.7 ± 1.6 µmol/l, respectively, consistent with zinc deficiency. HDIVZn, but not placebo, increased serum zinc levels above the deficiency cutoff of 10.7 µmol/l (p
- Published
- 2021
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