None listed
Conditions
Brief summary
An outbreak of a new virus called novel coronavirus (COVID-19 or 2019-CoV) infection has posed significant threats to the health of people worldwide and the global economy. There are no vaccines for this virus, and there is no specific treatment for people infected with the virus. In severe cases, COVID-19 virus can spread to the lungs and cause extreme difficulty with their breathing. We call this acute respiratory distress syndrome (ARDS). Zinc is a naturally occurring essential metal required for the normal function of the body. Numerous studies have been done showing the potential of zinc to inhibit viral infections (including the common cold) in clinical trials and experiments. It is our study hypothesis that zinc will reduce the severity of COVID-19 infection and improve the clinical outcomes of patients with COVID-19 infection. Therefore, we plan to perform a study to test whether zinc (given as Zn chloride) is effective and safe in subjects with COVID-19 infection and to work out whether giving zinc to patients can make them get better quicker.
Interventions
COVID-19 symptomatic confirmed hospitalized adult patients will be enrolled as soon as possible after fulfilling the criteria for randomisation. Patients will be allocated in a 1:1 ratio to either the treatment group receiving intravenous zinc chloride (0.5mg/kg/d) or to control group, receiving saline placebo alone.
Pharmaceutical grade Zinc Chloride stock solution obtained from an Australian company (Phebra Pty Ltd) will be diluted in 250ml of normal saline and infused, resulting in a final d
COVID-19 symptomatic confirmed hospitalized adult patients will be enrolled as soon as possible after fulfilling the criteria for randomisation. Patients will be allocated in a 1:1 ratio to either the treatment group receiving intravenous zinc chloride (0.5mg/kg/d) or to control group, receiving saline placebo alone. Pharmaceutical grade Zinc Chloride stock solution obtained from an Australian company (Phebra Pty Ltd) will be diluted in 250ml of normal saline and infused, resulting in a final dosage of 0.5mg/kg/d. Patients will be administered zinc for seven days. To standardise administration time, zinc infusions will commence around 9am but anywhere between 8am to 12pm in the morning is adequate. Zinc chloride will be administered via central venous or peripheral access over 3-6 hrs. We will monitor fidelity to the intervention by review of nursing documentation in the intravenous fluid given section of the electronic fluid balance chart. Note will be made of what was given, time commenced, volume given, time completed.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Consenting adult patients adult male or female, age 18 years or older. Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or another commercial or public health assay • Hospitalized with a SARS-CoV-2 infection of any duration • Ability to provide informed consent signed by study patient or legally acceptable representative • Willingness and ability to comply with study-related procedures/assessments • Have an oxygen saturation (SaO2) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) (Pao2: Fio2) at or below 300 mg Hg. • No chronic kidney disease (CKD) defined by stage II or higher using the Kidney Disease Improving Global Outcomes (KDIGO) classification
Exclusion criteria
• Age less than 18yo or pregnant or lactating female • Allergy to Zn • Severe hepatic impairment defined as Child C liver disease. • eGFR equal to or less than 30 mL/min/1.73 m2 (defined using CKD-EPI SCr formula) • History of any organ transplant which requires active immunosuppressive treatment which can interfere with kidney function • If a patient required cardiopulmonary resuscitation (CPR) within 14 days • DNR (do not resuscitate) DNI (do not intubate) orders • Death is deemed imminent or inevitable during this admission, and either the attending physician, patient or substitute decision-maker is not committed to active treatment • Already receiving dialysis (either acute or chronic) or imminent need of dialysis at the time of enrolment • Patients with known HIV infection • Patients with a known or suspected history of oxalate nephropathy or hyperoxaluria, scurvy, chronic iron overload, G-6PD deficiency • Clinician expects to prescribe Zinc for another indication • Patients with known haemochromatosis.
Outcome results
None listed