High-Dose Vitamin C Treatment in Critically Ill COVID-19 Patients

Covid19 Clinical Trial

Official title:

High-Dose Vitamin C Treatment in Critically Ill COVID-19 Patients, A Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710329
• Other study ID #: CVIT-3334
• Status: Completed
• Start date: January 16, 2021
• Est. completion date: February 10, 2021

Study information

• Verified date: February 2021
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute respiratory failure due to COVİD-19 pneumonia has poor prognosis and high mortality . Both the lack of an effective antiviral treatment and the low level evidence of the recommendations presented in the guidelines on other treatment methods have highlighted supportive treatments. Studies suggest that high-dose vitamin C treatment reduces mortality in patients with sepsis and ARDS, and may also be beneficial in COVİD-19 disease. In the study; the investigator aimed to determine the effect of Vitamin C on short-term mortality and length of intensive care stay in COVID-19 patients.

Description:

SARS-CoV-2 causes tissue damage in the endothelium and epithelium, increased vascular permeability and increased plasma levels of IL-6, IL-2, IL-7, IL-10 causing interstitial fibrosis in the lung is considered. Considering these factors in pathogenesis, a picture with high mortality from acute respiratory failure to severe ARDS emerges in critically ill COVID-19 patients. However, despite numerous studies, an effective antiviral treatment has not yet been found in COVID-19 disease. The low level of evidence for the recommendations presented in the guidelines on both treatment and mechanical ventilation has brought supportive treatments to the agenda. Recently, many articles have been published on the potential effects of anti-inflammatory and antioxidant treatments such as high-dose vitamin C, vitamin D, zinc and ozone therapy. In particular, high-dose intravenous vitamin C treatment is inexpensive, easily accessible, and it reduces mortality in patients with sepsis and ARDS in studies, suggesting that it may be beneficial in COVID-19 disease. this is a retrospective cohort study. The main goal of the study; to compare patients who did not receive high-dose vitamin C treatment in the first period of the epidemic and those who received treatment in the next period. the investigator aimed to determine the effect of Vitamin C on short-term mortality and length of stay in intensive care in critically ill COVID-19 patients. All patients' data on age, gender, body mass index, comorbidities (diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, other), PaO2 / FiO2 ratios, SOFA scores, ferritin, C-Reactive Protein, procalcitonin, lactate, neutrophil and lymphocyte values will be collected by scanning the hospital information system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 10, 2021
• Est. primary completion date: January 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Hospitalized with diagnosis of COVID-19, diagnosis confirmed by PCR test

• pneumonia due to COVID-19 was diagnosed with clinical and radiological findings

• Patients who developed acute respiratory failure (PaO2 / FiO2 300 despite the use of 6 l / min reservoir mask) caused by COVID-19 pneumonia

• Older than 18 year

Exclusion Criteria:

• Renal failure

• Hepatic failure

• End-stage malignity

• Primary lung disease (lung cancer, cardio-pulmonary edema)

• Patients who treated with tocilizumab

• Presence of diabetic ketoacidosis, use of insulin infusion, or frequent need for point-of-care glucose monitoring (>6 times/24 hour period) as determined by treating physician

• Active kidney stone

• patients with hospitalization in ICU less than 96 hours

Related Conditions & MeSH terms

• Acute Lung Injury
• Covid19
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Ascorbic acid
The daily administration of 6 grams of vitamin C intravenously in 4 equal doses every 6 hours occurred and the treatment lasted 96 hours. Vials containing 1.5 gr vitamin C were placed in 100 cc 5% dextrose and infused intravenously in 30-60 minutes. Prepared serum bottles and sets are wrapped with aluminum foil in order to protect them from sunlight.

Locations

Country	Name	City	State
Turkey	Sisli etfal training and resource hospital	Sisli	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Fowler AA 3rd, Fisher BJ, Kashiouris MG. Vitamin C for Sepsis and Acute Respiratory Failure-Reply. JAMA. 2020 Feb 25;323(8):792-793. doi: 10.1001/jama.2019.21987. — View Citation

Fowler AA 3rd, Truwit JD, Hite RD, Morris PE, DeWilde C, Priday A, Fisher B, Thacker LR 2nd, Natarajan R, Brophy DF, Sculthorpe R, Nanchal R, Syed A, Sturgill J, Martin GS, Sevransky J, Kashiouris M, Hamman S, Egan KF, Hastings A, Spencer W, Tench S, Mehkri O, Bindas J, Duggal A, Graf J, Zellner S, Yanny L, McPolin C, Hollrith T, Kramer D, Ojielo C, Damm T, Cassity E, Wieliczko A, Halquist M. Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial. JAMA. 2019 Oct 1;322(13):1261-1270. doi: 10.1001/jama.2019.11825. Erratum in: JAMA. 2020 Jan 28;323(4):379. — View Citation

Kim WY, Jo EJ, Eom JS, Mok J, Kim MH, Kim KU, Park HK, Lee MK, Lee K. Combined vitamin C, hydrocortisone, and thiamine therapy for patients with severe pneumonia who were admitted to the intensive care unit: Propensity score-based analysis of a before-after cohort study. J Crit Care. 2018 Oct;47:211-218. doi: 10.1016/j.jcrc.2018.07.004. Epub 2018 Jul 5. — View Citation

Moskowitz A, Huang DT, Hou PC, Gong J, Doshi PB, Grossestreuer AV, Andersen LW, Ngo L, Sherwin RL, Berg KM, Chase M, Cocchi MN, McCannon JB, Hershey M, Hilewitz A, Korotun M, Becker LB, Otero RM, Uduman J, Sen A, Donnino MW; ACTS Clinical Trial Investigators. Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Organ Injury in Septic Shock: The ACTS Randomized Clinical Trial. JAMA. 2020 Aug 18;324(7):642-650. doi: 10.1001/jama.2020.11946. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	short term mortality	Incidence of mortality at 28 days by all causes	days 1-28
Primary	Length of Intensive Care Unit Stay	Length of Intensive Care Unit Stay	up to 28 days
Secondary	vasopressor requirement	all types of vasopressor requirement in intensive care stay	1-28 days
Secondary	invasive mechanical ventilation requirement	invasive mechanical ventilation requirement	1-28 days
Secondary	PaO2/FiO2 ratio	Change in PaO2/FiO2 ratio from admission to 4th day	1-4 day
Secondary	C-reactive protein	Change in C-reactive protein from admission to 4th day	1-4 days
Secondary	procalcitonin	Change in procalcitonin from admission to 4th day	1-4 days
Secondary	Lymphocyte count	Change in Lymphocyte count from admission to 4th day	1-4 days
Secondary	ferritin	Change in ferritin from admission to 4th day	1-4 days
Secondary	SOFA	Change in Sequential Organ Failure Assessment score from admission to 4th day.	1-4 days