Early Use of Corticosteroid May Prolong SARS-CoV-2 Shedding in Non-Intensive Care Unit Patients with COVID-19 Pneumonia: A Multicenter, Single-Blind, Randomized Control Trial

Respiration. 2021;100(2):116-126. doi: 10.1159/000512063. Epub 2021 Jan 22.

Abstract

Background: There is still no clinical evidence available to support or to oppose corticosteroid treatment for coronavirus disease 2019 (COVID-19) pneumonia.

Objective: To investigate the efficacy and safety of corticosteroid given to the hospitalized patients with COVID-19 pneumonia.

Methods: This was a prospective, multicenter, single-blind, randomized control trial. Adult patients with COVID-19 pneumonia who were admitted to the general ward were randomly assigned to either receive methylprednisolone or not for 7 days. The primary end point was the incidence of clinical deterioration 14 days after randomization.

Results: We terminated this trial early because the number of patients with COVID-19 pneumonia in all the centers decreased in late March. Finally, a total of 86 COVID-19 patients underwent randomization. There was no difference of the incidence of clinical deterioration between the methylprednisolone group and control group (4.8 vs. 4.8%, p = 1.000). The duration of throat viral RNA detectability in the methylprednisolone group was 11 days (interquartile range, 6-16 days), which was significantly longer than that in the control group (8 days [2-12 days], p = 0.030). There were no significant differences between the 2 groups in other secondary outcomes. Mass cytometry discovered CD3+ T cells, CD8+ T cells, and NK cells in the methylprednisolone group which were significantly lower than those in the control group after randomization (p < 0.05).

Conclusions: From this prematurely closed trial, we found that the short-term early use of corticosteroid could suppress the immune cells, which may prolong severe acute respiratory syndrome coronavirus 2 shedding in patients with COVID-19 pneumonia.

Trial registration: ClinicalTrials.gov, NCT04273321.

Keywords: Coronavirus disease 2019; Corticosteroid; Outcome; Pneumonia; Virus shedding.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Anti-Bacterial Agents / therapeutic use
  • Antiviral Agents / therapeutic use
  • CD3 Complex
  • CD8-Positive T-Lymphocytes
  • COVID-19 / blood
  • COVID-19 / drug therapy*
  • COVID-19 / therapy
  • COVID-19 / transmission
  • COVID-19 Nucleic Acid Testing
  • Disease Progression
  • Early Medical Intervention
  • Extracorporeal Membrane Oxygenation
  • Female
  • Glucocorticoids / therapeutic use*
  • Hospitalization*
  • Humans
  • Killer Cells, Natural
  • Lymphocyte Count
  • Male
  • Methylprednisolone / therapeutic use*
  • Middle Aged
  • Oxygen Inhalation Therapy
  • Patients' Rooms
  • Pharynx / chemistry*
  • Pharynx / virology
  • Proportional Hazards Models
  • RNA, Viral / isolation & purification*
  • Respiration, Artificial
  • SARS-CoV-2
  • Single-Blind Method
  • T-Lymphocyte Subsets
  • T-Lymphocytes
  • Time Factors
  • Treatment Outcome
  • Virus Shedding*

Substances

  • Anti-Bacterial Agents
  • Antiviral Agents
  • CD3 Complex
  • Glucocorticoids
  • RNA, Viral
  • Methylprednisolone

Associated data

  • ClinicalTrials.gov/NCT04273321