Background Few specific medications have been proven effective for the treatment of patients with severe coronavirus disease 2019 (COVID-19). Here, we tested whether high-dose vitamin C infusion was effective for severe COVID-19. Methods This randomized, controlled, clinical trial was performed at 3 hospitals in Hubei, China. Patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the ICU were randomly assigned in as 1:1 ratio to either the high-dose intravenous vitamin C (HDIVC) or the placebo. HDIVC group received 12 g of vitamin C/50 ml every 12 h for 7 days at a rate of 12 ml/hour, and the placebo group received bacteriostatic water for injection in the same way within 48 h of arrival to ICU. The primary outcome was invasive mechanical ventilation-free days in 28 days (IMVFD28). Secondary outcomes were 28-day mortality, organ failure (Sequential Organ Failure Assessment (SOFA) score), and inflammation progression (interleukin-6). Results Only 56 critical COVID-19 patients were ultimately recruited due to the early control of the outbreak. There was no difference in IMVFD28 between two groups (26.0 [9.0–28.0] in HDIVC vs 22.0 [8.50–28.0] in control, p = 0.57). HDIVC failed to reduce 28-day mortality ( P = 0.27). During the 7-day treatment period, patients in the HDIVC group had a steady rise in the PaO 2 /FiO 2 (day 7: 229 vs. 151 mmHg, 95% CI 33 to 122, P = 0.01), which was not observed in the control group. IL-6 in the HDIVC group was lower than that in the control group (19.42 vs. 158.00; 95% CI -301.72 to -29.79; P = 0.04) on day 7. Conclusion This pilot trial showed that HDIVC failed to improve IMVFD28, but might show a potential signal of benefit in oxygenation for critically ill patients with COVID-19 improving PaO2/FiO2 even though.
【저자키워드】 severe acute respiratory syndrome coronavirus 2, Coronavirus disease 2019, high-dose intravenous vitamin C, 【초록키워드】 COVID-19, Treatment, SARS-CoV-2, Inflammation, coronavirus, clinical trial, Trial, severe COVID-19, IL-6, hospital, Vitamin C, Infection, 28-day mortality, interleukin-6, progression, outcome, ICU, China, Randomized, outbreak, Patient, Placebo, SOFA, assessment, medication, Organ failure, Oxygenation, intravenous, Critically ill patient, paO2/fiO2, High-dose, acute respiratory syndrome, Primary outcome, water for injection, control group, 95% CI, failure, severe coronavirus disease, no difference, treatment period, HDIVC, High-dose vitamin C, effective, benefit, secondary, Randomly, IMPROVE, Result, tested, recruited, was performed, reduce, assigned, two group, 1:1, critical COVID-19 patient, IMVFD28, invasive mechanical, PaO, the placebo group, with COVID-19, 【제목키워드】 Trial, Critically ill, COVID-19 patient, High-dose vitamin C,