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Marie-Hélène Masse
Julie Ménard
Sheila Sprague


Thanks to all Participating Centers and collaborators for engaging in this research program!

Thanks to the CCCTG for endorsing this research project.

Study Overview LOVIT-COVID




Background
The COVID-19 pandemic began on 11 March 2020. There is no specific treatment. Vitamin C may mitigate the inflammatory response associated with COVID-19.

Objective
To compare the effect of high-dose intravenous vitamin C vs. placebo on a composite of death or persistent organ dysfunction – defined as dependency on mechanical ventilation, new renal replacement therapy, or vasopressors – assessed at 28 days.

Primary Outcome
Death or persistent organ dysfunction (defined as continued
dependency on mechanical ventilation, new renal replacement
therapy, or vasopressors) at 28 days

Secondary Outcomes
  • Number of whole and part study days for which the patient is alive and not admitted to an ICU up until the end of study day 21;
  • Persistent organ dysfunction-free days in ICU, up to day 28;
  • Mortality and health-related quality of life at 6 months;
  • Daily organ function (SOFA score days 1, 2, 3, 4, 7, 10, 14, and 28);
  • Global tissue dysoxia, biomarkers for inflammation, infection, and endothelial injury on days 1, 3, 7;
  • Occurrence of stage 3 acute kidney injury as defined by KDIGO criteria;
  • Acute hemolysis;
  • Hypoglycemia, as defined by core lab-validated glucose level <3.8 mmol/L.
Study Design
Parallel-group allocation-concealed blinded randomized controlled trial.

Inclusion Criteria
  1. Patients ≥18 years old;
  2. Confirmed diagnosis of COVID-19;
  3. Admitted to a hospital (e.g. ward or intensive care unit (ICU)).
Exclusion Criteria
  1. Receiving or have received vasopressors during current hospital admission;
  2. More than 24 hours has elapsed since receipt of non-invasive ventilatory support (high-flow nasal cannula or continuous positive airway pressure or non-invasive ventilation) or invasive mechanical ventilation;
  3. Patient is expected to be discharged from the hospital in the next 24 hours;
  4. More than 14 days have elapsed since the commencement of hospital admission with respiratory illness;
  5. Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency;
  6. Known sickle cell anemia;
  7. Pregnancy or breastfeeding;
  8. Known allergy to vitamin C;
  9. Known kidney stones within the past 1 year;
  10. Received any intravenous vitamin C during this hospitalization unless incorporated in parenteral nutrition;
  11. Expected death or withdrawal of life-sustaining treatments within 48 hours;
  12. Previously enrolled in this study;
  13. Previously enrolled in a trial for which co-enrolment is not allowed (co-enrolment to be determined case by case).

Randomization
Web-based randomization system available 24/7. Eligible patients will be randomized in a 1:1 ratio to vitamin C or matching placebo. We will use permuted blocks of undisclosed and variable size and stratify randomization by site.

Study Intervention
Experimental arm: vitamin C 50 mg/kg every 6 hours for 96 hours. Control arm: placebo.

Follow-up
Daily during hospital stay and telephone follow-up at 6 months. Sample Size Up to 800 patients.