Efficacy and Safety of Corticosteroids in COVID-19

Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails

There is still controversy about the effective of glucocorticoids for the treatment of novel coronavirus pneumonia. This is a prospective randomized controlled trails. The aim is to explore the effectiveness and safety of glucocorticoids in the treatment of novel coronavirus pneumonia.

Study Overview

• Status: Completed
• Conditions: COVID-19; Novel Coronavirus Pneumonia
• Intervention / Treatment: Drug: Methylprednisolone

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Youan Hospital
  • Wuhan, China
    • Renmin Hospital of Wuhan University
  • Wuhan, China
    • Tianyou Hospital Affiliated to Wuhan University of Science and Technology
  • Wuhan, China
    • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Xiangyang, China
    • the first peopel hospital of Xiangyang
  • Hubei
    • Wuhan, Hubei, China
      • Hubei province hospital of integrated Chinese & Western Medicine
    • Yichang, Hubei, China
      • Yichang First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age more than 18 years old
• accord with the clinical diagnosis and/ or etiological diagnosis diagnostic criteria of Novel coronavirus pneumonia (COVID-19).
• admitted in the general wards
• be able to sign informed consent

Exclusion Criteria:

• severe immunosuppression (HIV infection, long-term use of immunosuppressive agents
• pregnant or lactation period women
• glucocorticoids are needed for other diseases
• unwilling or unable to participate or complete the study
• participate in other study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MP group	Drug: Methylprednisolone; Methylprednisolone 1mg/kg/day ivgtt for 7 days.
No Intervention: Con group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of treatment failure in 14 days	The clinical symptoms and signs continue to deteriorate, or new pulmonary or extrapulmonary lesions appear, or the chest imaging indicates the progress, and the patient is transferred to ICU or intubation and invasive ventilation or died.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical cure incidence in 14 days	The clinical symptoms and signs improved or alleviated (the temperature be normal , respiratory symptoms improved significantly, imaging showed obvious absorption) and no additional or alternative treatment was needed.	14 days
the duration of virus change to negative	the duration from admission to virus negative	30 days
mortality at day 30	the patient die in 30 days	30 days
ICU admission rate in 30 days	the patients transform to ICU because of clinical deteriorate in 30 days	30 days

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Publications and helpful links

General Publications

• Tang X, Feng YM, Ni JX, Zhang JY, Liu LM, Hu K, Wu XZ, Zhang JX, Chen JW, Zhang JC, Su J, Li YL, Zhao Y, Xie J, Ding Z, He XL, Wang W, Jin RH, Shi HZ, Sun B. 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Actual): April 15, 2020
• Study Completion (Actual): April 15, 2020

Study Registration Dates

• First Submitted: February 15, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: Methylprednisolone in COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No