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Role of Mega Dose of Vitamin C in Critical COVID-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04682574
Recruitment Status : Completed
First Posted : December 23, 2020
Last Update Posted : May 6, 2022
Sponsor:
Information provided by (Responsible Party):
Muhammad Mansoor Hafeez, University of Lahore

Study Description
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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.

Condition or disease Intervention/treatment Phase
Corona Virus Infection Drug: Vitamin C Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Mega Dose Vitamin C in Critically Ill COVID-19 Patients: A Randomized Control Trial
Actual Study Start Date : November 2, 2020
Actual Primary Completion Date : February 28, 2022
Actual Study Completion Date : March 10, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: vitamin C
The dose would be 30 grams a day (10 grams TDS) for 3 days with standard treatment
 Drug: Vitamin C
mega dose is given to the selected critically ill patients
No Intervention: Placebo
Distill water in the same dose with same standard treatment


Outcome Measures
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Primary Outcome Measures :
  1. Partial pressure of Oxygen in arterial blood to fraction of inspired Oxygen (P/F ratio) [ Time Frame: 1 and 4th day ]
  2. Survival analysis [ Time Frame: 28 days follow up ]

Secondary Outcome Measures :
  1. Length of Hospital stay [ Time Frame: Admission to discharge ]
  2. Need for intubation [ Time Frame: 28 days ]
    number of intubations needed in both groups.

  3. Inflammatory markers [ Time Frame: before the start of treatment (day 1) and on day 4 ]
    comparison of the inflammatory markers, CRP, D.Dimer, Procalcitonin, LDH, TLC and hematological variables at day four after the intervention started.

  4. APACHE II score [ Time Frame: before the start of treatment (day 1) and on day 4 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

critically ill patients admitted in ICU

Exclusion Criteria:

allergic to Vitamin C didnt given the consent

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04682574


Locations
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Pakistan
Bahria Town International Hospital
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
University of Lahore
More Information
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Responsible Party: Muhammad Mansoor Hafeez, Doctor, University of Lahore
ClinicalTrials.gov Identifier: NCT04682574    
Other Study ID Numbers: IRBEC/BIH/09-2020
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Virus Diseases
Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Ascorbic Acid
 Vitamins
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents