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Title: Randomised controlled trial for high-dose intravenous zinc as adjunctive therapy in SARS-CoV-2 (COVID-19) positive critically ill patients: trial protocol.
Austin Authors: Perera, Marlon ;El Khoury, John ;Chinni, Vidyasagar ;Bolton, Damien M ;Qu, Liang G ;Johnson, Paul D R ;Trubiano, Jason A ;McDonald, Christine F ;Jones, Daryl A ;Bellomo, Rinaldo ;Patel, Oneel;Ischia, Joseph J 
Affiliation: Surgery
Infectious Diseases
Respiratory and Sleep Medicine
Intensive Care
General Medicine
Issue Date: 2-Dec-2020 2020-12-02
Publication information: BMJ open 2020; 10(12): e040580
Abstract: SARS-CoV-2 (COVID-19) has caused an international pandemic of respiratory illness, resulting in significant healthcare and economic turmoil. To date, no robust vaccine or treatment has been identified. Elemental zinc has previously been demonstrated to have beneficial effects on coronaviruses and other viral respiratory infections due to its effect on RNA polymerase. Additionally, zinc has well-demonstrated protective effects against hypoxic injury-a clear mechanism of end-organ injury in respiratory distress syndrome. We aimed to assess the effect of high-dose intravenous zinc (HDIVZn) on SARS-CoV-2 infection. The end of study analyses will evaluate the reduction of impact of oxygen saturations or requirement of oxygen supplementation. We designed a double-blind randomised controlled trial of daily HDIVZn (0.5 mg/kg) versus placebo. Primary outcome measures are lowest oxygen saturation (or greatest level of supplemental oxygenation) for non-ventilated patients and worst PaO2/FiO2 for ventilated patients. Following power calculations, 60 hospitalised patients and 100 ventilated patients will be recruited to demonstrate a 20% difference. The duration of follow-up is up to the point of discharge. Ethical approval was obtained through the independent Human Research Ethics Committee. Participant recruitment will commence in May 2020. Results will be published in peer-reviewed medical journals. ACTRN126200000454976.
DOI: 10.1136/bmjopen-2020-040580
ORCID: 0000-0002-1138-6389
PubMed URL: 33268419
Type: Journal Article
Subjects: infectious diseases
public health
respiratory infections
Appears in Collections:Journal articles

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