SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI)

March 6, 2024 updated by: Virginia Commonwealth University
This study will evaluate the safety of a 96-hour intravenous vitamin C infusion protocol (50 mg/kg every 6 hours) in patients with hypoxemia and suspected COVID-19.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The intravenous vitamin C treatment protocol will be comprised of four intravenous infusions a day, that is 50 mg/kg every 6 hours in patients with laboratory-confirmed SARS-CoV-2 infection manifesting COVID-19 (Novel Coronavirus Disease 2019) with hypoxemia. Treatment protocol will continue for 4 days (96 hours), and, if needed, the last study-specific bloodwork with being collected on day 7. All subjects will be followed to day 28 (phase I) and day 90 (phase II) for collection of clinical outcomes data through electronic health records (EHR) even though the treatment protocol will be completed by 96 hours from randomization at the latest. Secondary outcome data will also be collected either during in-person (clinic) visit or via telephone at the 60 and 90-day follow-up.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults of 18 years or older
  • Patients hospitalized with a diagnosis of COVID-19 based on central laboratory-confirmed COVID-19 Novel Coronavirus Disease-2019, based on a positive SARS-CoV-2 RT-PCR confirmed within 72 hours prior to enrollment of nasal, oropharyngeal, or BAL specimen with hypoxemia, (i.e., decrease in oxygenation, as outlined below)
  • Pulse oximetry saturation (SpO2) < 93% on room air in WHO COVID-19 ordinal scale 3 patients, regardless the need for assisted ventilation, or oxygenation.
  • Any new requirement of supplemental oxygen, with any oxygen device (WHO COVID-19 ordinal scale 4-7, regardless of pulse oximetry reading)
  • In patients with supplemental oxygen at home, any increase in the requirement of supplemental oxygen.
  • In ICU level care

Exclusion Criteria:

  • Age less than 18 years
  • Known allergy to Vitamin C
  • Inability to obtain consent from patient or next of kin
  • Presence of diabetic ketoacidosis
  • ANY history of oxalate stones at any time
  • Patients with Kidney Disease Improving Global Outcomes (KDIGO), CKD stage 4 (eGFR < 30 ml/min, CKD stage 5 and end-stage renal disease on dialysis patients are excluded.
  • Patients with Acute Kidney Injury, stage 3.
  • Pregnant, or lactating
  • Known diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Patients who received the following medications within 7 days prior to enrollment, or plan to receive during enrollment, or 7 days after enrollment: aluminum hydroxide, bortezomib, copper, deferoxamine, amphetamines including derivatives such as fluphenazine.
  • Patients with active sickle cell crisis
  • Prisoners
  • Patients outside ICU level care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Infusion
L-Ascorbic Acid (Vitamin C), intravenous infusion
Drug: L-ascorbic acid
50 mg/kg intravenous vitamin C infusion every 6 hours for up to 96 hours
Other Names:
  • Vitamin C, Intravenous
Placebo Comparator: Placebo
Dextrose 5% Water
Other: Placebo
Dextrose 5% Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in COVID Disease Status
Time Frame: Over 27 days from baseline, day 60 and day 90 day
COVID disease status was measured for improvement using the World Health Organization (WHO) ordinal scale for clinical improvement of COVID-19 over ICU admission within 27 days. The WHO scale is a 9-point ordinal scale ranging from uninfected (0), ambulatory (1-2), hospitalized with severe disease (5), hospitalized with intubation and organ support (6-7) and death (score of 8).
Over 27 days from baseline, day 60 and day 90 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Safety Biomarkers - Serum Oxalate
Time Frame: On days 5,7 and 14
Change in serum oxalate levels
On days 5,7 and 14
Renal Safety Biomarkers - Urine Oxalate Stones
Time Frame: On days 5,7 and 14
Microscopic analysis of urine for presence of oxalate stones
On days 5,7 and 14
Renal Safety Biomarkers - 24-hour Urine Oxalate Levels
Time Frame: On days 5,7 and 14
Renal safety will be Measured via renal safety biomarkers - 24- hour urine oxalate level
On days 5,7 and 14
Acute Kidney Injury-free Days
Time Frame: Over 27 days from baseline
Renal-failure free days, with AKI defined by the KDIGO criteria
Over 27 days from baseline
Number of Deaths
Time Frame: Over 27 days from baseline, day 60 and day 90 day
Mortality by all cause was comprehensively collected using hospital encounter information over 27 days from baseline, in addition to public record review at day 60 and day 90. Results for this outcome represents the number of deaths that have occurred between each time point.
Over 27 days from baseline, day 60 and day 90 day
Change in Plasma Ferritin Levels
Time Frame: Day 0 (baseline), day 1, day 7
Difference in plasma ferritin levels in ng/mL, compared to baseline levels
Day 0 (baseline), day 1, day 7
Change in Plasma D-dimer Levels
Time Frame: Day 0 (baseline), days 1, 2, 3, 4, 5, 6, and 7
Difference in D-dimer levels in mcg/mL, compared to baseline levels
Day 0 (baseline), days 1, 2, 3, 4, 5, 6, and 7
Change in Serum Lactate Dehydrogenase (LDH) Levels
Time Frame: Day 0 (baseline), days 1, 2, 3, 4, 5, 6 and 7
Difference in lactate dehydrogenase (LDH) levels in units/L, compared to baseline levels
Day 0 (baseline), days 1, 2, 3, 4, 5, 6 and 7
Change in Plasma IL-6 Levels
Time Frame: Day 0 (baseline), days 1, 2, 3, 4, 5, 6 and 7
Difference in plasma IL-6 levels in pg/mL, compared to baseline levels
Day 0 (baseline), days 1, 2, 3, 4, 5, 6 and 7
Number of Patients Alive and Free of Respiratory Failure
Time Frame: At 28-days
Respiratory failure defined as resource utilization requiring at least 1 of the following: Endotracheal intubation and mechanical ventilation, Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20L/min with fraction of delivered oxygen ≥0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation
At 28-days
Number of Patients Alive and Free of Invasive Mechanical Ventilation
Time Frame: At 28-days
Number of patients alive and not requiring invasive mechanical ventilation. The results represent the number of patients who were ventilator free.
At 28-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Study Director: Brian Davis, MD, Hunter Holmes McGuire VA Medical Center - Richmond, VA
  • Principal Investigator: Alpha (Berry) A Fowler, III, MD, Virginia Commonwealth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2020

Primary Completion (Actual)

June 10, 2022

Study Completion (Actual)

June 10, 2022

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20018977

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no default plan to share individual participant data. May be considered upon reaching the VCU IRB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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