Randomised controlled trial for high-dose intravenous zinc as adjunctive therapy in SARS-CoV-2 (COVID-19) positive critically ill patients: trial protocol.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
02 Dec 2020
Historique:
entrez: 3 12 2020
pubmed: 4 12 2020
medline: 22 12 2020
Statut: epublish

Résumé

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 PaO 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.

Identifiants

pubmed: 33268419
pii: bmjopen-2020-040580
doi: 10.1136/bmjopen-2020-040580
pmc: PMC7712927
doi:

Substances chimiques

Zinc J41CSQ7QDS
Oxygen S88TT14065

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e040580

Informations de copyright

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Marlon Perera (M)

Department of Surgery, Austin Health, Heidelberg, Victoria, Australia marlonlperera@gmail.com.

John El Khoury (J)

Department of Surgery, Austin Health, Heidelberg, Victoria, Australia.

Vidyasagar Chinni (V)

Department of Surgery, Austin Health, Heidelberg, Victoria, Australia.

Damien Bolton (D)

Department of Surgery, Austin Health, Heidelberg, Victoria, Australia.

Liang Qu (L)

Department of Surgery, Austin Health, Heidelberg, Victoria, Australia.

Paul Johnson (P)

Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia.

Jason Trubiano (J)

Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia.

Christine F McDonald (CF)

Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia.

Daryl Jones (D)

Intensive Care Unit Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.
Department of Medicine, Austin Health, Heidelberg, Victoria, Australia.

Rinaldo Bellomo (R)

Intensive Care Unit Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.
Department of Medicine, Austin Health, Heidelberg, Victoria, Australia.

Oneel Patel (O)

Department of Surgery, Austin Health, Heidelberg, Victoria, Australia.

Joseph Ischia (J)

Department of Surgery, Austin Health, Heidelberg, Victoria, Australia.

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