NCT04323514

Use of Ascorbic Acid in Patients With COVID 19

Status unknown NA Last updated 26 March 2020

What this trial tests

NA trial testing Vitamin C in Hospitalized Patients With Covid-19 Pneumonia in 500 participants. Status unknown.

Timeline

13 March 2020

Primary endpoint
13 March 2021

13 March 2021

Quick facts

Lead sponsor	University of Palermo
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	500
Start date	13 March 2020
Primary completion	13 March 2021
Estimated completion	13 March 2021
Sites	1 location across Italy

Drugs / interventions tested

• Vitamin C — full drug profile →

Conditions studied

• Hospitalized Patients With Covid-19 Pneumonia — all drugs for Hospitalized Patients With Covid-19 Pneumonia →

Sponsor

University of Palermo

Who can join

Eligibility, any sex, with Hospitalized Patients With Covid-19 Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Different studies showed that ascorbic acid (vitaminC) positively affects the development and maturation of T-lymphocytes, in particular NK (natural Killer) cells involved in the immune response to viral agents. It also contributes to the inhibition of ROS production and to the remodulation of the cytokine network typical of systemic inflammatory syndrome.

Recent studies have also demonstrated the effectiveness of vitamin C administration in terms of reducing mortality, in patients with sepsis hospitalized in intensive care wards.

Given this background, in the light of the current COVID-19 emergency, since the investigators cannot carry out a randomized controlled trial, it is their intention to conduct a study in the cohort of hospitalized patients with covid-19 pneumonia, administering 10 gr of vitamin C intravenously in addition to conventional therapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
   Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
2. Immune-boosting role of vitamins D, C, E, zinc, selenium and omega-3 fatty acids: Could they help against COVID-19?
   Shakoor H, Feehan J, Al Dhaheri AS, Ali HI, et al · · 2021 · cited 206× · PMID 33308613 · DOI 10.1016/j.maturitas.2020.08.003
3. COVID-19 and Cancer: a Comprehensive Review.
   Gosain R, Abdou Y, Singh A, Rana N, et al · · 2020 · cited 187× · PMID 32385672 · DOI 10.1007/s11912-020-00934-7
4. Devilishly radical NETwork in COVID-19: Oxidative stress, neutrophil extracellular traps (NETs), and T cell suppression.
   Schönrich G, Raftery MJ, Samstag Y. · · 2020 · cited 165× · PMID 32773102 · DOI 10.1016/j.jbior.2020.100741
5. Vitamin C-An Adjunctive Therapy for Respiratory Infection, Sepsis and COVID-19.
   Holford P, Carr AC, Jovic TH, Ali SR, et al · · 2020 · cited 117× · PMID 33297491 · DOI 10.3390/nu12123760
6. Flattening the COVID-19 Curve With Natural Killer Cell Based Immunotherapies.
   Market M, Angka L, Martel AB, Bastin D, et al · · 2020 · cited 115× · PMID 32655581 · DOI 10.3389/fimmu.2020.01512
7. Safety and effectiveness of high-dose vitamin C in patients with COVID-19: a randomized open-label clinical trial.
   JamaliMoghadamSiahkali S, Zarezade B, Koolaji S, SeyedAlinaghi S, et al · · 2021 · cited 102× · PMID 33573699 · DOI 10.1186/s40001-021-00490-1
8. Comprehensive analysis of drugs to treat SARS‑CoV‑2 infection: Mechanistic insights into current COVID‑19 therapies (Review).
   Nitulescu GM, Paunescu H, Moschos SA, Petrakis D, et al · · 2020 · cited 93× · PMID 32468014 · DOI 10.3892/ijmm.2020.4608