NCT04401150

Brief Summary

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
392

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

August 14, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2022

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

1.9 years

First QC Date

May 21, 2020

Last Update Submit

April 20, 2023

Conditions

Vitamin CCOVID-19Hospitalized Patients

Keywords

Vitamin CCOVID-19Hospitalized patientsPandemicCoronavirus

Outcome Measures

Primary Outcomes (1)

  • Death or persistent organ dysfunction

    Number of deceased participants or with persistant organ dysfunction (dependency on mechanical ventilation, new renal replacement therapy, or vasopressors).

    Both assessed at 28 days

Secondary Outcomes (15)

  • Number of intensive care unit-free days

    Assessed at 21 days

  • Persistent organ dysfunction-free days in ICU

    Assessed at 28 days

  • Number of patients deceased at 6 months

    6 months

  • Health related quality of life in 6-month survivors

    6 months

  • Organ function

    Days 1, 2, 3, 4, 7, 10, 14, 28

  • +10 more secondary outcomes

Study Arms (2)

Vitamin C

EXPERIMENTAL

Vitamin C: 50 mg/kg of weight administered intravenously every 6 hours for 96 hours (16 doses).

Drug: Vitamin C

Control

PLACEBO COMPARATOR

Normal saline (0.9% NaCl) or dextrose 5% in water (D5W) in a volume to match the vitamin C.

Drug: Control

Interventions

Vitamin CDRUG

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).

Also known as: Ascorbic acid
Vitamin C
ControlDRUG

Dextrose 5% in water of normal saline (0.9% NaCL) in a volume to match vitamin C.

Also known as: Placebo
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of COVID-19;
  • Admitted to hospital (ward or intensive care unit).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Center of the CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Research Centre of the CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

  • LOVIT-COVID Investigators, on behalf of the Canadian Critical Care Trials Group, and the REMAP-CAP Investigators; Adhikari NKJ, Hashmi M, Tirupakuzhi Vijayaraghavan BK, Haniffa R, Beane A, Webb SA, Angus DC, Gordon AC, Cook DJ, Guyatt GH, Berry LR, Lorenzi E, Mouncey PR, Au C, Pinto R, Menard J, Sprague S, Masse MH, Huang DT, Heyland DK, Nichol AD, McArthur CJ, de Man A, Al-Beidh F, Annane D, Anstey M, Arabi YM, Battista MC, Berry S, Bhimani Z, Bonten MJM, Bradbury CA, Brant EB, Brunkhorst FM, Burrell A, Buxton M, Cecconi M, Cheng AC, Cohen D, Cove ME, Day AG, Derde LPG, Detry MA, Estcourt LJ, Fagbodun EO, Fitzgerald M, Goossens H, Green C, Higgins AM, Hills TE, Horvat C, Ichihara N, Jayakumar D, Kanji S, Khoso MN, Lawler PR, Lewis RJ, Litton E, Marshall JC, McAuley DF, McGlothlin A, McGuinness SP, McQuilten ZK, McVerry BJ, Murthy S, Parke RL, Parker JC, Reyes LF, Rowan KM, Saito H, Salahuddin N, Santos MS, Saunders CT, Seymour CW, Shankar-Hari M, Tolppa T, Trapani T, Turgeon AF, Turner AM, Udy AA, van de Veerdonk FL, Zarychanski R, Lamontagne F. Intravenous Vitamin C for Patients Hospitalized With COVID-19: Two Harmonized Randomized Clinical Trials. JAMA. 2023 Nov 14;330(18):1745-1759. doi: 10.1001/jama.2023.21407.

    PMID: 37877585DERIVED

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • François Lamontagne, MD, FRCPC, MSc

    Université de Sherbrooke and CIUSSS de l'Estrie - CHUS

    PRINCIPAL INVESTIGATOR

  • Neill K Adhikari, MDCM, FRCPC, MSc

    Sunnybrook Health Sciences Centre, University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Only the pharmacist of the participating site will be unblinded for the preparation of the study drug to be administered.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 26, 2020

Study Start

August 14, 2020

Primary Completion

July 15, 2022

Study Completion

December 6, 2022

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations

CA(2)