Trial ACTRN12620000454976
Publication Patel O, J Med Virol, 2021 (published paper)
Funding: Public/non profit (Australian Urologic Cancer Research Trust)
Conflict of interest: No
| Methods | |
| RCT Blinding: quadruple blinding | |
| Location :
Single center / Australia Follow-up duration (days): 28 | |
| Inclusion criteria | Consenting adult patients
Adult male or female, Age ≥ 18 years old; 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 <18 or pregnant or lactating female;
Allergy to Zn; Severe hepatic impairment defined as Child C liver disease; eGFR ≤ 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 |
| Interventions | |
| Treatment
Zinc 0.5 mg/kg IV once a day over 3 hours for up to 7 days [elemental zinc concentration 0.24 mg/kg/day] |
|
| Control
Placebo | |
| Participants | |
| Randomized 33 participants (n1=* / n2= *) | |
| Characteristics of participants N=33 Mean age : NR 21 males Severity : Mild: n=15 / Moderate: n=13/ Severe: n=2 Critical: n=3 | |
| Primary outcome | |
| In the register 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. Feasibility. Timepoint: Worst recorded level of oxygenation during the 7 days of intervention. | |
| In the report Level of oxygenation expressed as oxygen flow (in litres/min) required to maintain blood oxygen levels (SpO2) above 94% and the worst (lowest) PaO2/FiO2 ratio in ventilated patients | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Low |
| General comment |
In addition to all available versions of the published article, the study registry, statistical analysis plan and protocol were used in data extraction and risk of bias assessment. The study did not reach its target sample size due to reduction of eligible participants. Consequently, several outcomes, including some primary outcomes, listed in the protocol and registry were not reported.
Quote: "Our study did not reach its target enrollment because stringent public health measures markedly reduced new patient presentations to zero. Consequently, we could not adequately assess the primary outcome of whether HDIVZn reduced the level of oxygenation in non‐ventilated (Figure 3) or improved the PaO2/ FiO2 ratio in the four ventilated patients (data not shown) and other clinical efficacy outcomes (Table 2)" The study did not provide the proportion randomized per arm (only the overall number randomized). There was no change from the protocol or trial registration in the intervention and control treatments. |