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A randomized, open-label study to evaluate the efficacy and safety of low-dose corticosteroids in hospitalized patients with novel coronavirus pneumonia (COVID-19)

A randomized, open-label study to evaluate the efficacy and safety of low-dose corticosteroids in hospitalized patients with novel coronavirus pneumonia (COVID-19)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029656
Enrollment
Unknown
Registered
2020-02-09
Start date
2020-02-14
Completion date
Unknown
Last updated
2020-02-17

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

control group:Standard treatment
experimental group:Standard treatment and methylprednisolone for injection

Sponsors

Wuhan Pulmonary Hosptial
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults (defined as age >= 18 years); 2. Patients with new type of coronavirus infection confirmed by PCR / serum antibodies; 3. The time interval between symptom onset and random enrollment is within 10 days.The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used; 4. Imaging confirmed pneumonia; 5. In the state of no oxygen at rest, the patient's blood oxygen saturation SPO2 = 24) or oxygenation index <= 300mmHg.

Exclusion criteria

Exclusion criteria: 1. Known to receive hormone therapy orally or intravenously; 2. Hormone therapy is needed due to concomitant disease upon admission; 3. Patients with diabetes are receiving oral medication or insulin therapy; 4. Known contraindications to dexamethasone or other excipients (such as refractory hypertension; epilepsy or delirium and glaucoma); 5. Known active gastrointestinal bleeding in the past 3 months; 6. Known difficulties in correcting hypokalemia; 7. Known secondary bacterial or fungal infections; 8. Known immunosuppressive status (such as chemotherapy / radiotherapy / HIV infection within one month after surgery); 9. The clinician thinks that participating in the trial may cause patient damage (such as severe lymphocyte reduction); 10. The patient may be transferred to a non-participating hospital within 72 hours.

Design outcomes

Primary

MeasureTime frame
ECG;Chest imaging;Complications;vital signs;NEWS2 score;

Countries

China

Contacts

Public ContactRonghui Du

Wuhan Pulmonary Hospital

bluesearh006@sina.com+86 15337110926

Outcome results

None listed

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