Phase 2
Completed N=47
SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI)
COVID · Lung Injury, Acute · Chronic Kidney Disease
Source: ClinicalTrials.gov NCT04344184 ↗
Enrolled (actual)
47
Serious AEs
2.1%
Results posted
Apr 2024
Primary outcomePrimary: Change in COVID Disease Status — 5.09; 5.48; 3.05; 3.00 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in COVID Disease Status |
5.09; 5.48; 3.05; 3.00; 3.00; 2.88 | — |
| SECONDARY Renal Safety Biomarkers - Serum Oxalate |
8.96; 10.5; 13.4; 19.0 | — |
| SECONDARY Renal Safety Biomarkers - Urine Oxalate Stones |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Renal Safety Biomarkers - 24-hour Urine Oxalate Levels |
40.8; 21.5; 25.5; 92; 32.7 | — |
| SECONDARY Acute Kidney Injury-free Days |
7.36; 8.04 | — |
| SECONDARY Number of Deaths |
5; 7; 0; 0; 0; 0 | — |
| SECONDARY Change in Plasma Ferritin Levels |
917; 1510; 694; 1100; 638; 1320 | — |
| SECONDARY Change in Plasma D-dimer Levels |
2.85; 5.60; 2.65; 5.52; 2.60; 6.32 | — |
| SECONDARY Change in Serum Lactate Dehydrogenase (LDH) Levels |
475; 667; 421; 639; 445; 644 | — |
| SECONDARY Change in Plasma IL-6 Levels |
475; 667; 421; 639; 445; 644 | — |
| SECONDARY Number of Patients Alive and Free of Respiratory Failure |
2; 0 | — |
| SECONDARY Number of Patients Alive and Free of Invasive Mechanical Ventilation |
2 | — |
Eligibility 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.
- 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
Data sourced from ClinicalTrials.gov (NCT04344184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.