NCT04682574

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

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

Study Start

First participant enrolled

November 2, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

1.3 years

First QC Date

December 22, 2020

Last Update Submit

May 2, 2022

Conditions

Corona Virus Infection

Outcome Measures

Primary Outcomes (2)

  • Partial pressure of Oxygen in arterial blood to fraction of inspired Oxygen (P/F ratio)

    1 and 4th day

  • Survival analysis

    28 days follow up

Secondary Outcomes (4)

  • Length of Hospital stay

    Admission to discharge

  • Need for intubation

    28 days

  • Inflammatory markers

    before the start of treatment (day 1) and on day 4

  • APACHE II score

    before the start of treatment (day 1) and on day 4

Study Arms (2)

vitamin C

ACTIVE COMPARATOR

The dose would be 30 grams a day (10 grams TDS) for 3 days with standard treatment

Drug: Vitamin C

Placebo

NO INTERVENTION

Distill water in the same dose with same standard treatment

Interventions

Vitamin CDRUG

mega dose is given to the selected critically ill patients

vitamin C

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • critically ill patients admitted in ICU

You may not qualify if:

  • allergic to Vitamin C didnt given the consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahria Town International Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 23, 2020

Study Start

November 2, 2020

Primary Completion

February 28, 2022

Study Completion

March 10, 2022

Last Updated

May 6, 2022

Record last verified: 2022-05

Locations

PA(1)