NCT04710329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

January 16, 2021

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2021

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

9 days

First QC Date

January 13, 2021

Last Update Submit

February 10, 2021

Conditions

Respiratory Distress Syndrome, AdultCovid19

Keywords

coronavirus disease 2019Ascorbic Acidintensive care

Outcome Measures

Primary Outcomes (2)

  • short term mortality

    Incidence of mortality at 28 days by all causes

    days 1-28

  • Length of Intensive Care Unit Stay

    Length of Intensive Care Unit Stay

    up to 28 days

Secondary Outcomes (8)

  • vasopressor requirement

    1-28 days

  • invasive mechanical ventilation requirement

    1-28 days

  • PaO2/FiO2 ratio

    1-4 day

  • C-reactive protein

    1-4 days

  • procalcitonin

    1-4 days

  • +3 more secondary outcomes

Study Arms (2)

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

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

Interventions

Ascorbic acidDRUG

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.

C Vitnon-C Vit

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who admitted to the intensive care unit with the diagnosis of acute respiratory failure due to COVID-19 pneumonia

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli etfal training and resource hospital

Şişli, Istanbul, 34376, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 31573637BACKGROUND

  • 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.

    PMID: 32096845BACKGROUND

  • 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.

    PMID: 30029205BACKGROUND

  • 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.

    PMID: 32809003BACKGROUND

MeSH Terms

Conditions

Respiratory Distress SyndromeCOVID-19

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Surhan Çınar

    Sisli etflal resource and training hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist medical doctor

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 14, 2021

Study Start

January 16, 2021

Primary Completion

January 25, 2021

Study Completion

February 10, 2021

Last Updated

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)