Back to resultsRole of Mega Dose of Vitamin C in Critical COVID-19 Patients
Primary Purpose
Corona Virus Infection
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Vitamin C
Sponsored by
About this trial
This is an interventional treatment trial for Corona Virus Infection
Eligibility Criteria
Inclusion Criteria:
critically ill patients admitted in ICU
Exclusion Criteria:
allergic to Vitamin C didnt given the consent
Sites / Locations
- Bahria Town International Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
vitamin C
Placebo
Arm Description
The dose would be 30 grams a day (10 grams TDS) for 3 days with standard treatment
Distill water in the same dose with same standard treatment
Outcomes
Primary Outcome Measures
Partial pressure of Oxygen in arterial blood to fraction of inspired Oxygen (P/F ratio)
Survival analysis
Secondary Outcome Measures
Length of Hospital stay
Need for intubation
number of intubations needed in both groups.
Inflammatory markers
comparison of the inflammatory markers, CRP, D.Dimer, Procalcitonin, LDH, TLC and hematological variables at day four after the intervention started.
APACHE II score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04682574
Brief Title
Role of Mega Dose of Vitamin C in Critical COVID-19 Patients
Official Title
Effects of Mega Dose Vitamin C in Critically Ill COVID-19 Patients: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
March 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Vitamin C (ascorbic acid) is a water-soluble vitamin having anti-inflammatory, immunomodulatory, anti-oxidative, antithrombotic and antiviral properties. Considering these effects vitamin C should have beneficial impact in patients suffering from sepsis and acute respiratory distress syndrome (ARDS). The current study is designed to assess the beneficial effects of Vitamin C in COVID-19 infected patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
278 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamin C
Arm Type
Active Comparator
Arm Description
The dose would be 30 grams a day (10 grams TDS) for 3 days with standard treatment
Arm Title
Placebo
Arm Type
No Intervention
Arm Description
Distill water in the same dose with same standard treatment
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Intervention Description
mega dose is given to the selected critically ill patients
Primary Outcome Measure Information:
Title
Partial pressure of Oxygen in arterial blood to fraction of inspired Oxygen (P/F ratio)
Time Frame
1 and 4th day
Title
Survival analysis
Time Frame
28 days follow up
Secondary Outcome Measure Information:
Title
Length of Hospital stay
Time Frame
Admission to discharge
Title
Need for intubation
Description
number of intubations needed in both groups.
Time Frame
28 days
Title
Inflammatory markers
Description
comparison of the inflammatory markers, CRP, D.Dimer, Procalcitonin, LDH, TLC and hematological variables at day four after the intervention started.
Time Frame
before the start of treatment (day 1) and on day 4
Title
APACHE II score
Time Frame
before the start of treatment (day 1) and on day 4
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
critically ill patients admitted in ICU
Exclusion Criteria:
allergic to Vitamin C didnt given the consent
Facility Information:
Facility Name
Bahria Town International Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Role of Mega Dose of Vitamin C in Critical COVID-19 Patients
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