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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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17 February 2020 |
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Main ID: |
ChiCTR2000029656 |
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Date of registration:
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2020-02-09 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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)
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Scientific title:
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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) |
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Date of first enrolment:
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2020-02-14 |
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Target sample size:
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control group:50;experimental group:50; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=49086 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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0
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Countries of recruitment
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China
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Contacts
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Name:
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Ronghui Du
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Address:
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28 Baofeng Road, Qiaokou District, Wuhan, Hubei, China
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Telephone:
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+86 15337110926 |
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Email:
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bluesearh006@sina.com |
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Affiliation:
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Wuhan Pulmonary Hospital |
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Name:
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Li Li
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Address:
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28 Baofeng Road, Qiaokou District, Wuhan, Hubei, China
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Telephone:
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+86 13297001562 |
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Email:
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ly_li@aliyun.com |
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Affiliation:
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Wuhan Pulmonary Hospital |
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Key inclusion & exclusion criteria
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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 <= 94% or shortness of breath (breathing frequency >= 24) or oxygenation index <= 300mmHg.
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.
Age minimum:
18
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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novel coronavirus pneumonia (COVID-19)
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Intervention(s)
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control group:Standard treatment;experimental group:Standard treatment and methylprednisolone for injection;
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Primary Outcome(s)
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ECG;Chest imaging;Complications;vital signs;NEWS2 score;
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Source(s) of Monetary Support
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Emergency Project for 2019-nCoV of Ministry of Science and Technology
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Ethics review
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Status: Approved
Approval date: 29/01/2020
Contact:
Qionghong Duan
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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