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

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04710329

Collaborator

(none)

Enrollment

Location

Actual Duration (Days)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Adult Covid19	Drug: Ascorbic acid

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

78 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 16, 2021

Actual Primary Completion Date :

Jan 25, 2021

Actual Study Completion Date :

Feb 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
C Vit The patients who were admitted to the intensive care unit and received a high dose intravenous vitamin C protocol constituted the treatment group	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.
non-C Vit The patients who were admitted to the intensive care unit but did not receive the vitamin C protocol constituted the control group	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.

Arm

Intervention/Treatment

C Vit

The patients who were admitted to the intensive care unit and received a high dose intravenous vitamin C protocol constituted the treatment group

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.

non-C Vit

The patients who were admitted to the intensive care unit but did not receive the vitamin C protocol constituted the control group

Drug: Ascorbic acid

Outcome Measures

Primary Outcome Measures

short term mortality [days 1-28]
Incidence of mortality at 28 days by all causes
Length of Intensive Care Unit Stay [up to 28 days]
Length of Intensive Care Unit Stay

Secondary Outcome Measures

vasopressor requirement [1-28 days]
all types of vasopressor requirement in intensive care stay
invasive mechanical ventilation requirement [1-28 days]
invasive mechanical ventilation requirement
PaO2/FiO2 ratio [1-4 day]
Change in PaO2/FiO2 ratio from admission to 4th day
C-reactive protein [1-4 days]
Change in C-reactive protein from admission to 4th day
procalcitonin [1-4 days]
Change in procalcitonin from admission to 4th day
Lymphocyte count [1-4 days]
Change in Lymphocyte count from admission to 4th day
ferritin [1-4 days]
Change in ferritin from admission to 4th day
SOFA [1-4 days]
Change in Sequential Organ Failure Assessment score from admission to 4th day.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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