COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000454976.aspx

Prof Joseph Ischia

jjischia@unimelb.edu.au

2020-04-08

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

• 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

• 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.

2

Austin Health

18

100

Australia

Critical disease at enrollment

8: Critical disease at enrollment

160

In non-ventilated patients- Mean change in the worst (highest) level of oxygenation (oxygen flow in litres/min). This will be assessed by the nursing documentation in the participant's electronic record of the flow rate of oxygen delivered and the delivery method (ie nasal prongs; Hudson mask; or non-breather mask). In ventilated patients- Mean change in the worst (lowest) PaO2 /FiO2 ratio (in mmHg). This will be assessed by nursing documented PaO2 and FiO2 levels in the patient chart.[Worst recorded level of oxygenation during the 7 days of intervention.];Feasibility will be assesses by the following measures:• The primary assessment of our ability to blind treatment of the HDIVZn in a 250-ml saline preparation• Drug availability from supplier; storage and timely delivery to a patient• Good clinical practice documentation of drug prescription on Cerner (an electronic medical record); delivery to ICU by project research officer; double signing by nursing staff• Appropriate preparation of drug- onsite refrigeration storage; preparation with SOPs; maintenance of sterile conditions; protocol compliance; breaches; and variation; documentation processes including patient retention and follow-up rates• Determine the per-patient cost to estimate subsequent pivotal trial costs• Assess the process for efficient and effective data entry and analysisThese will be assessed by our research investigators on a regular basis and data collected in the case report forms.[During 7 days of intervention]

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 1397, "treatment_name": "Zinc", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]