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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT04344184
Collaborator
(none)
48
Enrollment
2
Locations
2
Arms
17.7
Actual Duration (Months)
24
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: L-ascorbic acid
  • Other: Placebo
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI)
Actual Study Start Date :
Dec 18, 2020
Actual Primary Completion Date :
Jun 10, 2022
Actual Study Completion Date :
Jun 10, 2022

Arms and Interventions

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: Standard of care

    Dextrose 5% Water

    Other: Placebo
    Dextrose 5% Water

    Outcome Measures

    Primary Outcome Measures

    1. Change in COVID disease status [Baseline to 28, 60 and 90 days]

      COVID disease status will be measured by the 9-point (from 0 to 8) World Health Organization (WHO) ordinal scale for disease improvement at 28 days.

    Secondary Outcome Measures

    1. Renal safety biomarkers - serum oxalate [On days 5,7 and 14]

      Change in serum oxalate levels

    2. Renal safety biomarkers - urine oxalate stones [On days 5,7 and 14]

      Microscopic analysis of urine for presence of oxalate stones

    3. Renal safety biomarkers - 24-hour urine oxalate levels [On days 5,7 and 14]

      24-hour urine oxalate levels

    4. Acute Kidney Injury-free days [On day 28, 90]

      Renal-failure free days, with AKI defined by the KDIGO criteria

    5. Number of deaths [On day 28, 60 and 90 days]

      Mortality by all causes

    6. Change in plasma ferritin levels [Days 1-7 compared with baseline]

      Difference in plasma ferritin levels in ng/mL, compared to baseline levels

    7. Change in plasma D-dimer levels [Days 1-7 compared with baseline]

      Difference in D-dimer levels in mcg/mL, compared to baseline levels

    8. Change in serum lactate dehydrogenase (LDH) levels [Days 1-7 compared with baseline]

      Difference in lactate dehydrogenase (LDH) levels in units/L, compared to baseline levels

    9. Change in plasma IL-6 levels [Days 1-7 compared with baseline]

      Difference in plasma IL-6 levels in pg/mL, compared to baseline levels

    10. Proportion of patients alive and free of respiratory failure [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

    11. Proportion of patients alive and free of invasive mechanical ventilation [At 28-days]

      Percentage of patients alive and not requiring invasive mechanical ventilation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    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 (see page 28).

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hunter Holmes McGuire VA Medical Center Richmond Virginia United States 23249
    2 Virginia Commonwealth University Richmond Virginia United States 23298

    Sponsors and Collaborators

    • Virginia Commonwealth University

    Investigators

    • Principal Investigator: Markos G Kashiouris, MD MPH, Virginia Commonwealth University
    • Study Director: Brian Davis, MD, Hunter Holmes McGuire VA Medical Center - Richmond, VA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT04344184
    Other Study ID Numbers:
    • HM20018977
    First Posted:
    Apr 14, 2020
    Last Update Posted:
    Jul 5, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Lung Injury
    Acute Lung Injury
    Wounds and Injuries
    Ascorbic Acid

    Study Results

    No Results Posted as of Jul 5, 2022