Clinical trial
Lessening Organ Dysfunction With VITamin C - COVID
Name
MP-31-2021-3741
Description
LOVIT-COVID is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in hospitalized COVID-19 patients.
Trial arms
Trial start
2020-08-14
Estimated PCD
2022-07-15
Trial end
2022-12-06
Status
Completed
Phase
Early phase I
Treatment
Vitamin C
Intravenous vitamin C administered in bolus doses of 50 mg/kg mixed in a 50-ml solution of either normal saline (0.9% NaCl) or dextrose 5% in water (D5W) during 30 to 60 minutes, every 6 hours for 96 hours (i.e. 200 mg/kg/day and 16 doses in total).
Arms:
Vitamin C
Other names:
Ascorbic acid
Control
Dextrose 5% in water of normal saline (0.9% NaCL) in a volume to match vitamin C.
Arms:
Control
Other names:
Placebo
Size
392
Primary endpoint
Death or persistent organ dysfunction
Both assessed at 28 days
Eligibility criteria
Inclusion Criteria:
* Confirmed diagnosis of COVID-19;
* Admitted to hospital (ward or intensive care unit).
Exclusion Criteria:
* Receiving or has received vasopressors during the current hospitalization;
* 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;
* Patient is expected to be discharged from the hospital in the next 24 hours;
* More than 14 days have elapsed since the commencement of hospital admission with respiratory illness;
* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency;
* Known sickle cell anemia
* Pregnancy or breastfeeding;
* Known allergy to vitamin C;
* Known kidney stones within the past 1 year;
* Received any intravenous vitamin C during this hospitalization unless incorporated in parenteral nutrition;
* Expected death or withdrawal of life-sustaining treatments within 48 hours;
* Previously enrolled in this study;
* Previously enrolled in a trial for which co-enrolment is not allowed (co- enrolment to be determined case by case).
The trial has broad eligibility criteria and includes all COVID-19 patients admitted to the hospital (e.g. hospital ward or the intensive care unit) who are not receiving vasopressors.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Only the pharmacist of the participating site will be unblinded for the preparation of the study drug to be administered.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 392, 'type': 'ACTUAL'}}
Updated at
2023-04-21
1 organization
1 product
1 drug
3 indications
Organization
Université de SherbrookeProduct
Vitamin CIndication
Ascorbic AcidIndication
COVID-19Indication
Hospitalized PatientsDrug
Varlilumab