| Study name |
The clinical value of corticosteroid therapy timing in the treatment of novel coronavirus pneumonia (COVID‐19): a prospective randomised controlled trial |
| Methods |
Trial design: open‐label RCT Sample size: 200 Setting: no information, probably inpatient Language: Chinese, English Number of centres: 3 Type of intervention (treatment/prevention): treatment |
| Participants |
Inclusion criteria
Patients who are > 18 years Definitely diagnosed with COVID‐19 (i.e. the diagnosis of 2019‐nCoV‐infected pneumonia patients was diagnosed according to the diagnostic criteria for novel coronavirus pneumonia diagnosis and treatment programme (trial version 5) issued by the National Health and Health Commission on 5 February 2020)
Exclusion criteria
Patients who are allergic to corticosteroids Patients who are diagnosed with adrenal insufficiency -
Severe immunosuppression, one of the following:
infection with HIV and CD4 cell count below 350 cells per microlitre; immunosuppressive therapy after solid organ transplantation; neutropenia (< 500 cells/microlitre) and so on.
Patients with cystic fibrosis or active tuberculosis Patients with gastrointestinal bleeding in the past 3 months Incomplete clinical data Participated in other clinical research Patients who cannot understand and execute the survey plan Patients who abandoned treatment
|
| Interventions |
Details of intervention
Group 1: early corticosteroid intervention group Group 2: middle‐late corticosteroid intervention group Dosage and route of administration: no information, most likely systemic
Treatment details of control group (e.g. dose, route of administration): no corticosteroid
Concomitant therapy: no information |
| Outcomes |
Primary study outcome: the time of duration of COVID‐19 nucleic acid RT‐PCR test results of respiratory specimens (such as throat swabs) or blood specimens change to negative
Among secondary outcomes: 21‐day all‐cause mortality |
| Starting date |
1 March 2020 |
| Contact information |
Chen Zhenshun: +86 13627288300
Email: chzs1990@163.com |
| Notes |
Recruitment status: recruiting
Prospective completion date: 30 April 2020
Date last update was posted: 3 March 2020
Sponsor/funding: Science and Technology Department of Hubei Province |
