COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49086

Ronghui Du

bluesearh006@sina.com

2020-02-09

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

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 <= 94% or shortness of breath (breathing frequency >= 24) or oxygenation index <= 300mmHg.

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.

2

Wuhan Pulmonary Hosptial

18

None

China

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

100

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

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 0

[{"arm_notes": "", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]