COVID-19, Lung Injury, Acute, Kidney Injury
Conditions
Brief summary
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.
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.
Interventions
DRUGL-ascorbic acid
50 mg/kg intravenous vitamin C infusion every 6 hours for up to 96 hours
OTHERPlacebo
Dextrose 5% Water
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in COVID Disease Status | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal Safety Biomarkers - Urine Oxalate Stones | On days 5,7 and 14 | Microscopic analysis of urine for presence of oxalate stones |
| Renal Safety Biomarkers - 24-hour Urine Oxalate Levels | On days 5,7 and 14 | Renal safety will be Measured via renal safety biomarkers - 24- hour urine oxalate level |
| Acute Kidney Injury-free Days | Over 27 days from baseline | Renal-failure free days, with AKI defined by the KDIGO criteria |
| Number of Deaths | 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. |
| Change in Plasma Ferritin Levels | Day 0 (baseline), day 1, day 7 | Difference in plasma ferritin levels in ng/mL, compared to baseline levels |
| Renal Safety Biomarkers - Serum Oxalate | On days 5,7 and 14 | Change in serum oxalate levels |
| Change in Serum Lactate Dehydrogenase (LDH) Levels | 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 |
| Change in Plasma IL-6 Levels | 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 |
| Number 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 |
| Number of Patients Alive and Free of Invasive Mechanical Ventilation | At 28-days | Number of patients alive and not requiring invasive mechanical ventilation. The results represent the number of patients who were ventilator free. |
| Change in Plasma D-dimer Levels | Day 0 (baseline), days 1, 2, 3, 4, 5, 6, and 7 | Difference in D-dimer levels in mcg/mL, compared to baseline levels |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Infusion L-Ascorbic Acid (Vitamin C), intravenous infusion
L-ascorbic acid: 50 mg/kg intravenous vitamin C infusion every 6 hours for up to 96 hours | 22 |
| Placebo Dextrose 5% Water
Placebo: Dextrose 5% Water | 25 |
| Total | 47 |
Baseline characteristics
| Characteristic | Infusion | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 13.4 | 60.7 years STANDARD_DEVIATION 15 | 60.8 years STANDARD_DEVIATION 16.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 45 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 19 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 10 Participants | 25 Participants | 15 Participants |
| Sex/Gender, Customized female | 12 Participants | 20 Participants | 8 Participants |
| Sex/Gender, Customized male | 10 Participants | 24 Participants | 14 Participants |
| Sex/Gender, Customized unknown | 0 Participants | 3 Participants | 3 Participants |
| Weight at Admission (kg) | 106 Kilograms STANDARD_DEVIATION 29.5 | 100 Kilograms STANDARD_DEVIATION 30 | 95.3 Kilograms STANDARD_DEVIATION 30.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 22 | 7 / 25 |
| other Total, other adverse events | 0 / 22 | 3 / 25 |
| serious Total, serious adverse events | 0 / 22 | 1 / 25 |
Outcome results
Primary
Change in COVID Disease Status
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).
Time frame: Over 27 days from baseline, day 60 and day 90 day
Population: All data points were not available for all subjects at follow-up, Day 27, 60, 90, due to participants not actively being admitted within the ICU and available for assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infusion | Change in COVID Disease Status | Baseline (day 0) | 5.09 score on a scale | Standard Deviation 0.811 |
| Infusion | Change in COVID Disease Status | Day 27 | 3.05 score on a scale | Standard Deviation 0.218 |
| Infusion | Change in COVID Disease Status | Day 60 | 3.00 score on a scale | Standard Deviation 0 |
| Infusion | Change in COVID Disease Status | Day 90 | 3.00 score on a scale | Standard Deviation 0 |
| Placebo | Change in COVID Disease Status | Day 90 | 2.81 score on a scale | Standard Deviation 0.544 |
| Placebo | Change in COVID Disease Status | Baseline (day 0) | 5.48 score on a scale | Standard Deviation 0.714 |
| Placebo | Change in COVID Disease Status | Day 60 | 2.88 score on a scale | Standard Deviation 0.6 |
| Placebo | Change in COVID Disease Status | Day 27 | 3.00 score on a scale | Standard Deviation 0 |
Secondary
Acute Kidney Injury-free Days
Renal-failure free days, with AKI defined by the KDIGO criteria
Time frame: Over 27 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infusion | Acute Kidney Injury-free Days | 7.36 Days | Standard Deviation 8.17 |
| Placebo | Acute Kidney Injury-free Days | 8.04 Days | Standard Deviation 8.18 |
Secondary
Change in Plasma D-dimer Levels
Difference in D-dimer levels in mcg/mL, compared to baseline levels
Time frame: Day 0 (baseline), days 1, 2, 3, 4, 5, 6, and 7
Population: Data was not available for all of the subjects for all of the days and therefore was not analyzed as reflected in the numbers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infusion | Change in Plasma D-dimer Levels | Baseline | 2.85 mg/L FEU | Standard Deviation 3.45 |
| Infusion | Change in Plasma D-dimer Levels | Day 1 | 2.65 mg/L FEU | Standard Deviation 2.24 |
| Infusion | Change in Plasma D-dimer Levels | Day 2 | 2.60 mg/L FEU | Standard Deviation 2.42 |
| Infusion | Change in Plasma D-dimer Levels | Day 3 | 2.29 mg/L FEU | Standard Deviation 2.18 |
| Infusion | Change in Plasma D-dimer Levels | Day 4 | 2.71 mg/L FEU | Standard Deviation 2.57 |
| Infusion | Change in Plasma D-dimer Levels | Day 5 | 2.84 mg/L FEU | Standard Deviation 2.84 |
| Infusion | Change in Plasma D-dimer Levels | Day 6 | 2.84 mg/L FEU | Standard Deviation 373 |
| Infusion | Change in Plasma D-dimer Levels | Day 7 | 5.12 mg/L FEU | Standard Deviation 5.26 |
| Placebo | Change in Plasma D-dimer Levels | Day 7 | 3.80 mg/L FEU | Standard Deviation 4.54 |
| Placebo | Change in Plasma D-dimer Levels | Baseline | 5.60 mg/L FEU | Standard Deviation 6.55 |
| Placebo | Change in Plasma D-dimer Levels | Day 4 | 3.44 mg/L FEU | Standard Deviation 3.47 |
| Placebo | Change in Plasma D-dimer Levels | Day 1 | 5.52 mg/L FEU | Standard Deviation 5.87 |
| Placebo | Change in Plasma D-dimer Levels | Day 6 | 4.56 mg/L FEU | Standard Deviation 5.18 |
| Placebo | Change in Plasma D-dimer Levels | Day 2 | 6.32 mg/L FEU | Standard Deviation 7.04 |
| Placebo | Change in Plasma D-dimer Levels | Day 5 | 3.56 mg/L FEU | Standard Deviation 3.49 |
| Placebo | Change in Plasma D-dimer Levels | Day 3 | 4.99 mg/L FEU | Standard Deviation 5.34 |
Secondary
Change in Plasma Ferritin Levels
Difference in plasma ferritin levels in ng/mL, compared to baseline levels
Time frame: Day 0 (baseline), day 1, day 7
Population: The data is not available for all subjects for all days as reflected in the numbers analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infusion | Change in Plasma Ferritin Levels | Day 0 | 917 ng/mL | Standard Deviation 1350 |
| Infusion | Change in Plasma Ferritin Levels | Day 1 | 694 ng/mL | Standard Deviation 845 |
| Infusion | Change in Plasma Ferritin Levels | Day 7 | 638 ng/mL | Standard Deviation 488 |
| Placebo | Change in Plasma Ferritin Levels | Day 0 | 1510 ng/mL | Standard Deviation 1500 |
| Placebo | Change in Plasma Ferritin Levels | Day 1 | 1100 ng/mL | Standard Deviation 997 |
| Placebo | Change in Plasma Ferritin Levels | Day 7 | 1320 ng/mL | Standard Deviation 733 |
Secondary
Change in Plasma IL-6 Levels
Difference in plasma IL-6 levels in pg/mL, compared to baseline levels
Time frame: Day 0 (baseline), days 1, 2, 3, 4, 5, 6 and 7
Population: Not all data available for all subjects as indicated below for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infusion | Change in Plasma IL-6 Levels | Day 7 | 410 pg/mL | Standard Deviation 56.6 |
| Infusion | Change in Plasma IL-6 Levels | Baseline | 475 pg/mL | Standard Deviation 222 |
| Infusion | Change in Plasma IL-6 Levels | Day 1 | 421 pg/mL | Standard Deviation 160 |
| Infusion | Change in Plasma IL-6 Levels | Day 2 | 445 pg/mL | Standard Deviation 174 |
| Infusion | Change in Plasma IL-6 Levels | Day 3 | 428 pg/mL | Standard Deviation 105 |
| Infusion | Change in Plasma IL-6 Levels | Day 4 | 461 pg/mL | Standard Deviation 123 |
| Infusion | Change in Plasma IL-6 Levels | Day 5 | 519 pg/mL | Standard Deviation 388 |
| Infusion | Change in Plasma IL-6 Levels | Day 6 | 456 pg/mL | Standard Deviation 230 |
| Placebo | Change in Plasma IL-6 Levels | Day 6 | 502 pg/mL | Standard Deviation 155 |
| Placebo | Change in Plasma IL-6 Levels | Day 7 | 511 pg/mL | Standard Deviation 166 |
| Placebo | Change in Plasma IL-6 Levels | Day 3 | 606 pg/mL | Standard Deviation 227 |
| Placebo | Change in Plasma IL-6 Levels | Baseline | 667 pg/mL | Standard Deviation 192 |
| Placebo | Change in Plasma IL-6 Levels | Day 5 | 536 pg/mL | Standard Deviation 142 |
| Placebo | Change in Plasma IL-6 Levels | Day 1 | 639 pg/mL | Standard Deviation 190 |
| Placebo | Change in Plasma IL-6 Levels | Day 4 | 573 pg/mL | Standard Deviation 211 |
| Placebo | Change in Plasma IL-6 Levels | Day 2 | 644 pg/mL | Standard Deviation 227 |
Secondary
Change in Serum Lactate Dehydrogenase (LDH) Levels
Difference in lactate dehydrogenase (LDH) levels in units/L, compared to baseline levels
Time frame: Day 0 (baseline), days 1, 2, 3, 4, 5, 6 and 7
Population: Not all of the data was available for all of the subjects as listed below for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infusion | Change in Serum Lactate Dehydrogenase (LDH) Levels | Baseline | 475 mmol/L | Standard Deviation 222 |
| Infusion | Change in Serum Lactate Dehydrogenase (LDH) Levels | Day 1 | 421 mmol/L | Standard Deviation 160 |
| Infusion | Change in Serum Lactate Dehydrogenase (LDH) Levels | Day 2 | 445 mmol/L | Standard Deviation 174 |
| Infusion | Change in Serum Lactate Dehydrogenase (LDH) Levels | Day 3 | 428 mmol/L | Standard Deviation 105 |
| Infusion | Change in Serum Lactate Dehydrogenase (LDH) Levels | Day 4 | 461 mmol/L | Standard Deviation 123 |
| Infusion | Change in Serum Lactate Dehydrogenase (LDH) Levels | Day 5 | 519 mmol/L | Standard Deviation 388 |
| Infusion | Change in Serum Lactate Dehydrogenase (LDH) Levels | Day 6 | 456 mmol/L | Standard Deviation 230 |
| Infusion | Change in Serum Lactate Dehydrogenase (LDH) Levels | Day 7 | 410 mmol/L | Standard Deviation 56.6 |
| Placebo | Change in Serum Lactate Dehydrogenase (LDH) Levels | Day 7 | 511 mmol/L | Standard Deviation 166 |
| Placebo | Change in Serum Lactate Dehydrogenase (LDH) Levels | Baseline | 667 mmol/L | Standard Deviation 192 |
| Placebo | Change in Serum Lactate Dehydrogenase (LDH) Levels | Day 4 | 573 mmol/L | Standard Deviation 211 |
| Placebo | Change in Serum Lactate Dehydrogenase (LDH) Levels | Day 1 | 639 mmol/L | Standard Deviation 190 |
| Placebo | Change in Serum Lactate Dehydrogenase (LDH) Levels | Day 6 | 502 mmol/L | Standard Deviation 155 |
| Placebo | Change in Serum Lactate Dehydrogenase (LDH) Levels | Day 2 | 644 mmol/L | Standard Deviation 227 |
| Placebo | Change in Serum Lactate Dehydrogenase (LDH) Levels | Day 5 | 536 mmol/L | Standard Deviation 142 |
| Placebo | Change in Serum Lactate Dehydrogenase (LDH) Levels | Day 3 | 606 mmol/L | Standard Deviation 227 |
Secondary
Number of Deaths
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.
Time frame: Over 27 days from baseline, day 60 and day 90 day
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infusion | Number of Deaths | Baseline to Day 27 | 5 Participants |
| Infusion | Number of Deaths | Day 28 to Day 60 | 0 Participants |
| Infusion | Number of Deaths | Day 61 to Day 90 | 0 Participants |
| Placebo | Number of Deaths | Baseline to Day 27 | 7 Participants |
| Placebo | Number of Deaths | Day 28 to Day 60 | 0 Participants |
| Placebo | Number of Deaths | Day 61 to Day 90 | 0 Participants |
Secondary
Number of Patients Alive and Free of Invasive Mechanical Ventilation
Number of patients alive and not requiring invasive mechanical ventilation. The results represent the number of patients who were ventilator free.
Time frame: At 28-days
Population: The analyzed population did not reflect all participants still in the study at this time point due to only collecting data for participants remaining in the ICU.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infusion | Number of Patients Alive and Free of Invasive Mechanical Ventilation | 2 Participants |
Secondary
Number of Patients Alive and Free of Respiratory Failure
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
Time frame: At 28-days
Population: The analyzed population did not reflect all participants still in the study at this time point due to only collecting data for participants remaining in the ICU.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infusion | Number of Patients Alive and Free of Respiratory Failure | 2 Participants |
| Placebo | Number of Patients Alive and Free of Respiratory Failure | 0 Participants |
Secondary
Renal Safety Biomarkers - 24-hour Urine Oxalate Levels
Renal safety will be Measured via renal safety biomarkers - 24- hour urine oxalate level
Time frame: On days 5,7 and 14
Population: Due to staffing/operational challenges in conjunction with only following participants during the ICU admission not all subjects participated in day 5, 7, \& 14 oxalate collection. During COVID, methods to limit access to potential exposure \& limited PPE restricted collection timepoints. Also, an internal facility error in collection process was noted by outside lab during processing samples. Facility process updated to include new methods, however multiple samples were unable to be processed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infusion | Renal Safety Biomarkers - 24-hour Urine Oxalate Levels | Day 5 | 40.8 umol/day | Standard Deviation 27 |
| Infusion | Renal Safety Biomarkers - 24-hour Urine Oxalate Levels | Day 14 | 92 umol/day | — |
| Placebo | Renal Safety Biomarkers - 24-hour Urine Oxalate Levels | Day 5 | 21.5 umol/day | Standard Deviation 16.3 |
| Placebo | Renal Safety Biomarkers - 24-hour Urine Oxalate Levels | Day 7 | 25.5 umol/day | Standard Deviation 6.36 |
| Placebo | Renal Safety Biomarkers - 24-hour Urine Oxalate Levels | Day 14 | 32.7 umol/day | Standard Deviation 26.7 |
Secondary
Renal Safety Biomarkers - Serum Oxalate
Change in serum oxalate levels
Time frame: On days 5,7 and 14
Population: Due to staffing/operational challenges in conjunction with only following participants during the ICU admission not all subjects participated in day 5, 7, \& 14 oxalate collection. During COVID, methods to limit access to potential exposure \& limited PPE restricted collection timepoints. Also, an internal facility error in collection process was noted by outside lab during processing samples. Facility process updated to include new methods, however multiple samples were unable to be processed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infusion | Renal Safety Biomarkers - Serum Oxalate | Day 5 | 8.96 umol per liter | Standard Deviation 9.41 |
| Placebo | Renal Safety Biomarkers - Serum Oxalate | Day 5 | 10.5 umol per liter | Standard Deviation 13 |
| Placebo | Renal Safety Biomarkers - Serum Oxalate | Day 7 | 13.4 umol per liter | Standard Deviation 9.48 |
| Placebo | Renal Safety Biomarkers - Serum Oxalate | Day 14 | 19.0 umol per liter | Standard Deviation 0 |
Secondary
Renal Safety Biomarkers - Urine Oxalate Stones
Microscopic analysis of urine for presence of oxalate stones
Time frame: On days 5,7 and 14
Population: Due to staffing/operational challenges in conjunction with only following participants during the ICU admission not all subjects participated in day 5, 7, \& 14 oxalate collection. During COVID, methods to limit access to potential exposure \& limited PPE restricted collection timepoints. Also, an internal facility error in collection process was noted by outside lab during processing samples. Facility process updated to include new methods, however multiple samples were unable to be processed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infusion | Renal Safety Biomarkers - Urine Oxalate Stones | Day 5 | 1 Participants |
| Infusion | Renal Safety Biomarkers - Urine Oxalate Stones | Day 7 | 0 Participants |
| Infusion | Renal Safety Biomarkers - Urine Oxalate Stones | Day 14 | 0 Participants |
| Placebo | Renal Safety Biomarkers - Urine Oxalate Stones | Day 5 | 0 Participants |
| Placebo | Renal Safety Biomarkers - Urine Oxalate Stones | Day 7 | 0 Participants |
| Placebo | Renal Safety Biomarkers - Urine Oxalate Stones | Day 14 | 0 Participants |