Trial · NCT04344184
SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI)
NCT04344184, Phase 2, Completed, Virginia Commonwealth University; results first posted 2024-04-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI). Trials, record NCT04344184. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04344184
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI)
- NCT number
- NCT04344184
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- COVID-19, Lung Injury, Acute, Kidney Injury
- Interventions
- L-ascorbic acid, Placebo
- First posted
- 2020-04-14
- Last updated
- 2024-04-04
- Results first posted
- 2024-04-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Renal Safety Biomarkers - Serum Oxalate | On days 5,7 and 14 | Change in serum oxalate levels |
| Secondary | Renal Safety Biomarkers - Urine Oxalate Stones | On days 5,7 and 14 | Microscopic analysis of urine for presence of oxalate stones |
| Secondary | 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 |
| Secondary | Acute Kidney Injury-free Days | Over 27 days from baseline | Renal-failure free days, with AKI defined by the KDIGO criteria |
| Secondary | 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. |
| Secondary | Change in Plasma Ferritin Levels | Day 0 (baseline), day 1, day 7 | Difference in plasma ferritin levels in ng/mL, compared to baseline levels |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in COVID Disease Status | Over 27 days from baseline, day 60 and day 90 day | 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. | score on a scale | MEAN |
| SECONDARY | Renal Safety Biomarkers - Serum Oxalate | On days 5,7 and 14 | 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. | umol per liter | MEAN |
| SECONDARY | Renal Safety Biomarkers - Urine Oxalate Stones | On days 5,7 and 14 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Renal Safety Biomarkers - 24-hour Urine Oxalate Levels | On days 5,7 and 14 | 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. | umol/day | MEAN |
| SECONDARY | Acute Kidney Injury-free Days | Over 27 days from baseline | Days | MEAN | |
| SECONDARY | Number of Deaths | Over 27 days from baseline, day 60 and day 90 day | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Plasma Ferritin Levels | Day 0 (baseline), day 1, day 7 | The data is not available for all subjects for all days as reflected in the numbers analyzed. | ng/mL | MEAN |
| SECONDARY | Change in Plasma D-dimer Levels | Day 0 (baseline), days 1, 2, 3, 4, 5, 6, and 7 | Data was not available for all of the subjects for all of the days and therefore was not analyzed as reflected in the numbers. | mg/L FEU | MEAN |
| SECONDARY | Change in Serum Lactate Dehydrogenase (LDH) Levels | Day 0 (baseline), days 1, 2, 3, 4, 5, 6 and 7 | Not all of the data was available for all of the subjects as listed below for analysis. | mmol/L | MEAN |
| SECONDARY | Change in Plasma IL-6 Levels | Day 0 (baseline), days 1, 2, 3, 4, 5, 6 and 7 | Not all data available for all subjects as indicated below for analysis. | pg/mL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in COVID Disease Status | Infusion | Baseline (day 0) | 5.09 | Standard Deviation 0.811 | score on a scale |
| Change in COVID Disease Status | Placebo | Baseline (day 0) | 5.48 | Standard Deviation 0.714 | score on a scale |
| Change in COVID Disease Status | Infusion | Day 27 | 3.05 | Standard Deviation 0.218 | score on a scale |
| Change in COVID Disease Status | Placebo | Day 27 | 3.00 | Standard Deviation 0 | score on a scale |
| Change in COVID Disease Status | Infusion | Day 60 | 3.00 | Standard Deviation 0 | score on a scale |
| Change in COVID Disease Status | Placebo | Day 60 | 2.88 | Standard Deviation 0.600 | score on a scale |
| Change in COVID Disease Status | Infusion | Day 90 | 3.00 | Standard Deviation 0 | score on a scale |
| Change in COVID Disease Status | Placebo | Day 90 | 2.81 | Standard Deviation 0.544 | score on a scale |
| Renal Safety Biomarkers - Serum Oxalate | Infusion | Day 5 | 8.96 | Standard Deviation 9.41 | umol per liter |
| Renal Safety Biomarkers - Serum Oxalate | Placebo | Day 5 | 10.5 | Standard Deviation 13.0 | umol per liter |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Infusion | 22 | |
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | COMPLETED | Infusion | 22 | |
| Overall Study | COMPLETED | Placebo | 25 | |
| Overall Study | NOT COMPLETED | Infusion | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vtach episode during study drug infusion | Cardiac disorders | Infusion | 0 | 22 | 0 |
| other | Vtach episode during study drug infusion | Cardiac disorders | Placebo | 2 | 25 | 2 |
| other | Infiltrated IV | General disorders | Infusion | 0 | 22 | 0 |
| other | Infiltrated IV | General disorders | Placebo | 1 | 25 | 1 |
| serious | While on study, a subject experienced arrythmia possible ventricular tachycardia (VT) and cardiac ar | Cardiac disorders | Infusion | 0 | 22 | 0 |
| serious | While on study, a subject experienced arrythmia possible ventricular tachycardia (VT) and cardiac ar | Cardiac disorders | Placebo | 1 | 25 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Infusion | 5 | 22 |
| Total, all-cause mortality | Placebo | 7 | 25 |
| Total, other adverse events | Infusion | 0 | 22 |
| Total, other adverse events | Placebo | 3 | 25 |
| Total, serious adverse events | Infusion | 0 | 22 |
| Total, serious adverse events | Placebo | 1 | 25 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Infusion vs Placebo: deaths from any cause | Trial comparisons |
| Infusion vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04344184
GET https://conductscience.org/api/trials/v1/NCT04344184/results?page=2