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

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ClinicalTrials.gov Identifier: NCT04344184
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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
COVID-19 Lung Injury, Acute Kidney Injury 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : December 18, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022


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 Name: Vitamin C, Intravenous

Placebo Comparator: Standard of care
Dextrose 5% Water
Other: Placebo
Dextrose 5% Water




Primary Outcome Measures :
  1. Change in COVID disease status [ Time Frame: 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 [ Time Frame: On days 5,7 and 14 ]
    Change in serum oxalate levels

  2. Renal safety biomarkers - urine oxalate stones [ Time Frame: On days 5,7 and 14 ]
    Microscopic analysis of urine for presence of oxalate stones

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

  4. Acute Kidney Injury-free days [ Time Frame: On day 28, 90 ]
    Renal-failure free days, with AKI defined by the KDIGO criteria

  5. Number of deaths [ Time Frame: On day 28, 60 and 90 days ]
    Mortality by all causes

  6. Change in plasma ferritin levels [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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

  11. Proportion of patients alive and free of invasive mechanical ventilation [ Time Frame: At 28-days ]
    Percentage of patients alive and not requiring invasive mechanical ventilation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344184


Contacts
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Contact: Markos G Kashiouris, MD MPH 804-305-7187 mkashiouris@vcu.edu
Contact: Alpha (Berry) A Fowler, III, MD 804-828-9071 alpha.fowler@vcuhealth.org

Locations
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United States, Virginia
Hunter Holmes McGuire VA Medical Center Recruiting
Richmond, Virginia, United States, 23249
Contact: Brian Davis, MD       brian.davis1@vcuhealth.org   
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Markos G Kashiouris, MD MPH Virginia Commonwealth University
Study Director: Brian Davis, MD Hunter Holmes McGuire VA Medical Center - Richmond, VA
Publications:

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04344184    
Other Study ID Numbers: HM20018977
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no default plan to share individual participant data. May be considered upon reaching the VCU IRB

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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:
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Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Respiration Disorders
Ascorbic Acid
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents