A pilot double-blind safety and feasibility randomised controlled trial of high-dose intravenous zinc in hospitalised COVID-19 patients.

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, randomised controlled trial to compare HDIVZn to placebo in hospitalised patients with COVID-19. We administered trial treatment once daily for a maximum of seven 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 randomised 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, 3 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 cut off of 10.7 µmol/l (P<0.001) by day 6. Our study did not reach its target enrolment because stringent public health measures markedly reduced patient hospitalisations. Hospitalised 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 patients. This article is protected by copyright. All rights reserved.