The Efficacy of High-Dose Pulse Therapy vs. Low-Dose Intravenous Methylprednisolone on Severe to Critical COVID-19 Clinical Outcomes: A Randomized Clinical Trial

Zahra Sahraei; Parnaz Panahi; Kouroush Solhjoukhah; Maryam Mesbah; Siamak Afaghi; Mahdi Amirdosara; Jamshid Salamzadeh; Farzad Esmaeili Tarki; Ilad Alavi Darazam

doi:10.5812/ijpr-137838

The Efficacy of High-Dose Pulse Therapy vs. Low-Dose Intravenous Methylprednisolone on Severe to Critical COVID-19 Clinical Outcomes: A Randomized Clinical Trial

Iran J Pharm Res. 2023 Aug 26;22(1):e137838. doi: 10.5812/ijpr-137838. eCollection 2023 Jan-Dec.

Authors

Zahra Sahraei¹, Parnaz Panahi¹, Kouroush Solhjoukhah¹, Maryam Mesbah¹, Siamak Afaghi², Mahdi Amirdosara³, Jamshid Salamzadeh⁴, Farzad Esmaeili Tarki⁵, Ilad Alavi Darazam⁶

Affiliations

¹ Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
² Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran,Iran.
³ Anesthesiology Research Center, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
⁴ School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
⁵ Research Institute of Internal Medicine, Shahid Modarres Hospital, Shahid Behehsti University of Medical Sciences,Tehran, Iran.
⁶ Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Abstract

Background: It remains unclear which formulation of the corticosteroid regimen has the optimum efficacies on COVID-19 pneumonia.

Objectives: The aim of this study was to compare the clinical outcomes of 2 different regimens in the treatment of acute respiratory distress syndrome (ARDS) caused by COVID-19: Methylprednisolone at a dose of 1 mg/kg every 12 hours (low-dose group) and 1000 mg/day pulse therapy for 3 days following 1 mg/kg methylprednisolone every 12 hours (high-dose group).

Methods: In this randomized clinical trial, patients with mild to moderate ARDS due to COVID-19 were randomly assigned to receive either low-dose (n = 47) or high-dose (n = 48) intravenous methylprednisolone regimens. Two groups were matched for age, gender, body mass index (BMI), comorbidities, leukocytes, lymphocytes, neutrophil/lymphocyte, platelet, hemoglobin, and inflammatory markers (erythrocyte sedimentation rate [ESR], C-reactive protein [CRP], and ferritin). Both regimens were initiated upon admission and continued for 10 days. The clinical outcome and secondary complications were evaluated.

Results: Evaluating in-hospital outcomes, no difference was revealed in the duration of intensive care unit (ICU) stays (5.4 ± 4.6 vs. 4.5 ± 4.9; P = 0.35), total hospital stays (8 ± 3.1 vs. 6.9 ± 3.4; P = 0.1), requirement rate for invasive ventilation (29.2% vs. 36.2%; P = 0.4) or non-invasive ventilation (16.6% vs 23.4%; P = 0.4), and hemoperfusion (16.6% vs 11.3%; P = 0.3) between the low- and high-dose groups. There was no significant difference in fatality due to ARDS (29.2% vs. 38.3%; P = 0.3) and septic shock (4.2% vs. 6.4%; P = 0.3) between the low- and high-dose groups. Patients in the high-dose group had significantly higher bacterial pneumonia co-infection events compared with those in the low-dose group (18.7% vs 10.6%; P = 0.01).

Conclusions: The use of adjuvant pulse therapy with intravenous methylprednisolone did not result in improved in-hospital clinical outcomes among patients with mild to moderate ARDS due to COVID-19. A higher risk of bacterial pneumonia should be considered in such cases as receiving a higher dose of steroids.

Keywords: COVID-19; Methylprednisolone; Pulse Therapy; SARS-CoV-2; Steroid.