A pilot double-blind safety and feasibility randomized controlled trial of high-dose intravenous zinc in hospitalized COVID-19 patients
Patel et al.
, A pilot double-blind safety and feasibility randomized controlled trial of high-dose intravenous zinc in..
, Journal of Medical Virology, doi:10.1002/jmv.26895
Small early terminated RCT with 33 hospitalized patients in Australia, 15 treated with zinc, showing no significant difference in clinical outcomes. Treatment increased zinc levels above the deficiency cutoff. Intravenous zinc 0.5mg/kg/day (elemental zinc concentration 0.24mg/kg/day) for up to 7 days. ACTRN12620000454976.
Although the 20% lower mortality is not statistically significant, it is consistent with the significant 29% lower mortality [9‑44%]
from meta analysis of the 19 mortality results to date
risk of death, 20.0% lower, RR 0.80, p = 1.00, treatment 2 of 15 (13.3%), control 3 of 18 (16.7%), NNT 30.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Patel et al., 25 Feb 2021, Double Blind Randomized Controlled Trial, Australia, peer-reviewed, 12 authors.
Abstract: Received: 6 December 2020
Revised: 18 January 2021
Accepted: 20 January 2021
A pilot double‐blind safety and feasibility randomized
controlled trial of high‐dose intravenous zinc in hospitalized
| Vidyasagar Chinni1,2
| John El‐Khoury1,2 |
| Ary S. Neto3,4
| Christine McDonald5 |
| Damien Bolton
Department of Surgery, The University of
Melbourne, Austin Health, Heidelberg,
| Jason Trubiano
Zinc inhibits replication of the SARS‐CoV virus. We aimed to evaluate the
Department of Urology, Austin Health,
Heidelberg, Victoria, Australia
safety, feasibility, and biological effect of administering high‐dose intravenous
zinc (HDIVZn) to patients with COVID‐19. We performed a Phase IIa double‐
Australian and New Zealand Intensive
Care‐Research Centre, Monash University,
Melbourne, Victoria, Australia
Centre for Integrated Critical Care, The
University of Melbourne, Parkville,
Department of Respiratory and Sleep
Medicine, Austin Health, Heidelberg,
Department of Intensive Care, Austin
Hospital, Heidelberg, Victoria, Australia
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
Department of Infectious Disease, The
University of Melbourne, Austin Health,
Heidelberg, Victoria, Australia
Joseph Ischia, Department of Surgery,
The University of Melbourne, Austin Health,
Heidelberg, VIC, Level 8, Lance Townsend
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 < .001) on Day 6. Our study did not
reach its target enrollment because stringent public health measures markedly
reduced patient hospitalizations. Hospitalized COVID‐19 patients demonstrated zinc deficiency. This can be corrected with HDIVZn. Such treatment
appears safe, feasible, and only associated with minimal peripheral infusion site
irritation. This pilot study justifies further investigation of this treatment in
COVID‐19, randomized controlled trial, trial protocol, zinc
Abbreviations: HDIVZn, high dose intravenous zinc; HFNC, high‐flow nasal cannula; NIV, noninvasive ventilation.
J Med Virol. 2021;93:3261–3267.
© 2021 Wiley Periodicals LLC
Cheap, safe, and easily administered interventions to improve
ME THO D S
2.1 | Human ethics
outcomes associated with COVID‐19 infection remain an important goal. Zinc and Zn‐salts inhibit viral infections..
is less effective
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