High-dose intravenous Vitamin C in early stages of severe acute respiratory syndrome coronavirus 2 infection: A double-blind, randomized, controlled clinical trial
Dr Kourosh Sadeghi, Zohre Labbani-Motlagh, Shahideh Amini, Rasoul Aliannejad, Anahita Sadeghi, Gita Shafiee, Ramin Heshmat, Mohamadreza Jafary, Mona Talaschian, Maryam Akhtari, Ahmadreza Jamshidi, Mahdi Mahmoudi
Journal of Research in Pharmacy Practice, doi:10.4103/jrpp.jrpp_30_22
Objective: Based on previous studies in the sepsis population, Vitamin C could prevent injuries when administered in high doses and before the damage is established. This study aimed to evaluate the protective potentials of high-dose Vitamin C in the progression of coronavirus disease 2019 (COVID-19). Methods: A double-blind, placebo-controlled clinical trial was conducted. Patients with moderate-to-severe disease severity based on the World Health Organization definition were enrolled and received 12 g/d Vitamin C (high-dose intravenous Vitamin C [HDIVC]) or placebo for 4 days. Sequential Organ Failure Assessment (SOFA) score as a primary outcome, National Early Warning Score, Ordinal Scale of Clinical Improvement, and cytokine storm biomarkers were recorded on days 0, 3, and 5. Survival was also assessed on day 28 after enrollment. Findings: Seventy-four patients (37 patients in each group) were enrolled from April 5, 2020, to November 19, 2020, and all patients completed follow-up. A lower increase in SOFA score during the first 3 days of treatment (+0.026 vs. +0.204) and a higher decrease in this parameter in the last 2 days (−0.462 vs. −0.036) were observed in the treatment group. However, these differences did not reach a significance level (P = 0.57 and 0.12, respectively). Other indices of clinical and biological improvement, length of hospitalization, and intensive care unit admission days were the same between the two groups. Treatment did not affect the 28-day mortality. Conclusion: Among patients with moderate-to-severe disease of COVID-19, the use of HDIVC plus standard care resulted in no significant difference in SOFA score or 28-day mortality compared to the standard care alone.
Authors' Contribution Z. Labbani-Motlagh, R. Aliannejad, A. Sadeghi, M. Jafary, and M. Talaschian: Acquisition of clinical data and patient's diagnosis and treatment, interpretation of data, drafting the article, and final approval of the article. G. Shafiee and R. Heshmat: Acquisition of data, the conception and design of the study, analysis and interpretation of data, drafting the article, and final approval of the article. S. Amini, M. Akhtari, A. Jamshidi, M. Mahmoudi, and K. Sadeghi: The conception and design of the study, interpretation of data, revising the article critically for important intellectual content, and final approval of the article.
Financial support and sponsorship This study was supported by a grant from the Deputy of Research, Tehran University of Medical Sciences (Grant No. 99-1-96-47169).
Conflicts of interest There are no conflicts of interest.
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