Corona Virus InfectionNCT04682574
Role of Mega Dose of Vitamin C in Critical COVID-19 Patients
A study testing Vitamin C in people with Corona Virus Infection, run by University of Lahore at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- Vitamin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Nov 2020to 10 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- critically ill patients admitted in ICU
Who cannot join
- allergic to Vitamin C didnt given the consent
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bahria Town International Hospital
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Mega Dose Vitamin C in Critically Ill COVID-19 Patients: A Randomized Control Trial
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.
- Conditions
- Corona Virus Infection
- Being tested
- Vitamin C
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
mega dose is given to the selected critically ill patients
| Study group | Role | What they receive |
|---|---|---|
| vitamin C | Active comparator | The dose would be 30 grams a day (10 grams TDS) for 3 days with standard treatment Receives: Drug: Vitamin C |
| Placebo | No intervention | Distill water in the same dose with same standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial pressure of Oxygen in arterial blood to fraction of inspired Oxygen (P/F ratio)
Measured: 1 and 4th day
Survival analysis
Measured: 28 days follow up
Secondary outcomes (4)
Length of Hospital stay
Measured: Admission to discharge
Need for intubation
number of intubations needed in both groups.
Measured: 28 days
Inflammatory markers
comparison of the inflammatory markers, CRP, D.Dimer, Procalcitonin, LDH, TLC and hematological variables at day four after the intervention started.
Measured: before the start of treatment (day 1) and on day 4
APACHE II score
Measured: before the start of treatment (day 1) and on day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start2 Nov 2020
- Primary completion28 Feb 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Mansoor Hafeez, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682574
- Sponsor's protocol ID
- IRBEC/BIH/09-2020
- Status last verified
- May 2022
- First submitted
- 22 Dec 2020
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mega Dose Vitamin C in Critically Ill COVID-19 Patients: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04682574
- Acronym / sponsor ID
- IRBEC/BIH/09-2020
- Conditions
- Corona Virus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin C | Active comparator | Drug: Vitamin CThe dose would be 30 grams a day (10 grams TDS) for 3 days with standard treatment |
| Placebo | No intervention | –Distill water in the same dose with same standard treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- critically ill patients admitted in ICU
Key exclusion criteria (1 listed)
- allergic to Vitamin C didnt given the consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin Cmega dose is given to the selected critically ill patients | Drug | vitamin C |
Primary outcome
Partial pressure of Oxygen in arterial blood to fraction of inspired Oxygen (P/F ratio)
Time frame: 1 and 4th day
Survival analysis
Time frame: 28 days follow up
4 secondary outcomes
Length of Hospital stay
Time frame: Admission to discharge
Need for intubation
Time frame: 28 days
Inflammatory markers
Time frame: before the start of treatment (day 1) and on day 4
APACHE II score
Time frame: before the start of treatment (day 1) and on day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Corona Virus Infection, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial pressure of Oxygen in arterial blood to fraction of inspired Oxygen (P/F ratio) (time frame: 1 and 4th day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.