Effects of High-dose Vitamin C on COVID-19

Phase 2

• Conditions: COVID-19.; COVID-19 confirmed by laboratory testing; U07.1

• Registration Number: IRCT20190917044805N2
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Older than 18 years old
admission with moderate to severe COVID-19 based on WHO definition
Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or Clinical assessment AND respiratory rate > 30 breaths/min; or severe respiratory distress; or SpO2 < 90% on room air.
Willing and be able to provide written informed consent prior to performing study procedures

Exclusion Criteria

Participation in any other clinical trial of an experimental treatment for COVID-19
Critical ill patients that need invasive mechanical ventilation
Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
Patients with past medical history of kidney stone
Pregnancy or breastfeeding
Documented diagnosis of cancer?
History of G6PD deficiency ?and interstitial lung disease ?
More than 1 gram/day intake of vitamin C ?supplement in last 7 days

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to clinical improvement (TTIC). Timepoint: day 0, 5, at discharge. Method of measurement: assessing respiratory rate, blood oxygen saturation, fever.;Change in Sequential Organ Failure Assessment (SOFA) score. Timepoint: day 0, 3, and 5. Method of measurement: SOFA scoring system.

Secondary Outcome Measures

Name	Time	Method
ational Early Warning Score (NEWS) 2. Timepoint: On day 0, 3, and 5. Method of measurement: NEWS 2 scoring system.;Ordinal scale for clinical improvement. Timepoint: On day 0, 3, and 5. Method of measurement: WHO scoring system.;Hospital Length of Stay. Timepoint: Days after receiving infusion. Method of measurement: days.;The change of inflammatory markers. Timepoint: On day 0, 3, and 5. Method of measurement: C-reactive protein, Neutrophil-lymphocyte ratio, Ferritin.;Mortality. Timepoint: During 30 days of receiving infusion. Method of measurement: Number of subjects.