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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

Tracking Information
First Submitted Date  ICMJE April 9, 2020
First Posted Date  ICMJE April 14, 2020
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE December 18, 2020
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
Number of ventilator-free days [ Time Frame: Up to 28 days ]
Documented days free off mechanical ventilation the first 28 days post enrollment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
  • Renal safety biomarkers - serum oxalate [ Time Frame: On days 5,7 and 14 ]
    Change in serum oxalate levels
  • Renal safety biomarkers - urine oxalate stones [ Time Frame: On days 5,7 and 14 ]
    Microscopic analysis of urine for presence of oxalate stones
  • Renal safety biomarkers - 24-hour urine oxalate levels [ Time Frame: On days 5,7 and 14 ]
    24-hour urine oxalate levels
  • Acute Kidney Injury-free days [ Time Frame: On day 28, 90 ]
    Renal-failure free days, with AKI defined by the KDIGO criteria
  • Number of deaths [ Time Frame: On day 28, 60 and 90 days ]
    Mortality by all causes
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • All-cause-mortality [ Time Frame: Up to 28 days ]
    Mortality at 28-days by all causes
  • Acute-inflammation-free days [ Time Frame: Up to 28 days ]
    Number of days free of acute inflammation (defined as CRP >= 10 mg/L)
  • Organ-failure-free days [ Time Frame: Up to 1 year ]
    Number of days that the participant is free of organ failure in ALL of the following organ systems: Cardiovascular, Respiratory, Neurological, Liver, Bone marrow organ, Renal
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI)
Official Title  ICMJE SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI)
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Lung Injury, Acute
  • Kidney Injury
Intervention  ICMJE
  • Drug: L-ascorbic acid
    50 mg/kg intravenous vitamin C infusion every 6 hours for up to 96 hours
    Other Name: Vitamin C, Intravenous
  • Other: Placebo
    Dextrose 5% Water
Study Arms  ICMJE
  • Active Comparator: Infusion
    L-Ascorbic Acid (Vitamin C), intravenous infusion
    Intervention: Drug: L-ascorbic acid
  • Placebo Comparator: Standard of care
    Dextrose 5% Water
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2020)
60
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2020)
200
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04344184
Other Study ID Numbers  ICMJE HM20018977
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Markos G Kashiouris, MD MPH Virginia Commonwealth University
Study Director: Brian Davis, MD Hunter Holmes McGuire VA Medical Center - Richmond, VA
PRS Account Virginia Commonwealth University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP