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

NCT ID: NCT04710329

Last Updated: 2021-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-16

Study Completion Date

2021-02-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Respiratory Distress Syndrome, Adult Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Ascorbic acid

Intervention Type DRUG

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

Ascorbic acid

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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nurcan coskun

specialist medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Surhan Çınar

Role: STUDY_CHAIR

Sisli etflal resource and training hospital

Locations

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Sisli etfal training and resource hospital

Şişli, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 31573637 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 32096845 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30029205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32809003 (View on PubMed)

Other Identifiers

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CVIT-3334

Identifier Type: -

Identifier Source: org_study_id

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