The clinical value of corticosteroid therapy timing in the treatment of novel coronavirus pneumonia (COVID-19): a prospective randomized controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000030481

Enrollment

Unknown

Registered

2020-03-03

Start date

2020-03-01

Completion date

Unknown

Last updated

2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Early corticosteroid intervention group:Early corticosteroid intervention

Middle-late corticosteroid intervention group:Middle-late corticosteroid intervention

Control group:No corticosteroid

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who are more than 18 years are definitely diagnosed with COVID-19. [That is, the diagnosis of 2019-nCoV-infected pneumonia patients was diagnosed according to the diagnostic criteria for novel coronavirus pneumonia diagnosis and treatment program (trial version 5) issued by the National Health and Health Commission on February 5, 2020.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to corticosteroid; 2. Patients who are diagnosed with adrenal insufficiency; 3. Severe immunosuppression, one of the following: infection with human immunodeficiency virus and CD4 cell count below 350 cells per microliter, immunosuppressive therapy after solid organ transplantation, neutropenia (less than 500 cells Per microliter) and so on; 4. Patients with cystic fibrosis or active tuberculosis; 5. Patients with gastrointestinal bleeding in the past three months; 6. Incomplete clinical data; 7. Participated in other clinical research; 8. Patients who cannot understand and execute the survey plan; 9. Patients who abandoned treatment.

Design outcomes

Primary

Measure	Time frame
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.;	—

Secondary

Measure	Time frame
Time for improvement of clinical symptoms (eg fever, cough, dyspnea, etc.);Imaging test improvement time (chest CT scan);Occurrence of complications during hospitalization (such as severe sepsis, septic shock, and acute renal failure, etc.);Mechanical ventilation time (days);ICU stay (days);Total hospitalization time (days);21-day all-cause mortality;The side effects of corticosteroid therapy (such as hypertension, hyperglycemia, and nosocomial infections);Laboratory testing indicators (such as immunological indicators, etc.);	—

Measure

Time frame

Time for improvement of clinical symptoms (eg fever, cough, dyspnea, etc.);Imaging test improvement time (chest CT scan);Occurrence of complications during hospitalization (such as severe sepsis, septic shock, and acute renal failure, etc.);Mechanical ventilation time (days);ICU stay (days);Total hospitalization time (days);21-day all-cause mortality;The side effects of corticosteroid therapy (such as hypertension, hyperglycemia, and nosocomial infections);Laboratory testing indicators (such as immunological indicators, etc.);

—

Countries

China

Contacts

Public ContactChen Zhenshun

Zhongnan Hospital of Wuhan University

chzs1990@163.com+86 13627288300

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026