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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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2 March 2020 |
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Main ID: |
ChiCTR2000030398 |
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Date of registration:
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2020-03-01 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomized, double-blind, placebo-controlled trial for evaluation of the efficacy and safety of bismuth potassium citrate capsules in the treatment of patients with novel coronavirus pneumonia (COVID-19).
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Scientific title:
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A randomized, double-blind, placebo-controlled trial for evaluation of the efficacy and safety of bismuth potassium citrate capsules in the treatment of patients with novel coronavirus pneumonia (COVID-19) |
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Date of first enrolment:
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2020-02-27 |
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Target sample size:
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Experimental group:170;Control group:170; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=50173 |
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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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N/A
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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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Liu Ying
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Address:
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1 Yintan Road, Dongxihu District, Wuhan, Hubei, China
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Telephone:
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+86 027-85509088 |
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Email:
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whsjytyy_gcp@qq.com |
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Affiliation:
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Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital) |
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Name:
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Zhang Dingyu
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Address:
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1 Yintan Road, Dongxihu District, Wuhan, Hubei, China
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Telephone:
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+86 13507117929 |
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Email:
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1813886398@qq.com |
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Affiliation:
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Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital) |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged 18 to 75 years men and women;
2. Inpatients with novel coronavirus(SARS-CoV-2) infection confirmed by PCR;
3. Agree and sign the informed consent form.
Exclusion criteria: 1. Cannot take medicine by mouth;
2. Those who are allergic to bismuth potassium citrate capsules or who have taken bismuth preparations within 1 month;
3. Critical patients meet one of the following conditions:
(1) Respiratory failure occurs and requires mechanical ventilation;
(2) Shock occurs;
(3) ICU monitoring and treatment is required for other organ failure;
4. Patients with long-term hemodialysis and known severe renal impairment (glomerular filtration rate <30ml / min / 1.73m2) or patients receiving continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
5. Pregnant woman and lactation period;
6. The patient may be transferred to a non-participating hospital within 72 hours;
7. Researchers deem unsuitable and cannot implement the protocol.
Age minimum:
18
Age maximum:
75
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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Experimental group:Capsules of bismuth potassium citrate, 2 capsules at a time, once every 12 hours; take warm water with breakfast and dinner; do not take high protein foods such as milk at the same time.;Control group:Simulated capsules of bismuth potassium citrate, 2 capsules at a time, once every 12 hours; take warm water with breakfast and dinner; do not take high protein foods such as milk at the same time.;
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Primary Outcome(s)
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Pharynx swabs, lower respiratory tract samples (sputum/endotracheal aspiration/alveolar lavage), and anal swabs rt-pcr of novel coronavirus nucleic acid negative conversion rate.;
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Secondary Outcome(s)
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1. 28-day clinical improvement time: the number of days from randomization to clinical improvement.Clinical improvement was defined as a reduction of 2 points on the 6-point scale of the patient's admission status or discharge.;2. Hospitalization duration of 28 days after admission: The number of days from randomization to discharge. Discharge criteria: body temperature returned to normal for more than 3 days; respiratory symptoms improved significantly; lung imaging showed a significant improvement of acute exudative lesions; Negative nucleic ac;3. Severe conversion rate for 28 days. At the time of enrollment, patients with light or popular type should meet one of the following three conditions : shortness of breath, RR >= 30 beats / minute; in the state of no oxygen inhalation, tip oxygen saturation <=93%; (PaO2)/(FiO2) <=300mmHg.;4. On the 3rd, 6th, 9th, and 12th days of enrollment, the RT-PCR novel coronavirus nucleic acid detection of negative rate were used to detect negative rate of swine swabs, lower respiratory tract samples (sputum / tracheal aspirate / alveolar lavage fluid) and anal swabs.;5. On the 3rd, 6th, 9th, 12th, and 15th days of enrollment, the blood novel coronavirus nucleic acid was used to detect the negative conversion rate though RT-PCR.;6.Time from admission to negative RT-PCR test result.;7. Blood was collected before taking medicine in the morning on the 9th, 12th, 15th days,and 30 minutes after taking the medicine on the 9th, 12th days of enrollment to measure bismuth concentration.The bismuth concentration in sputum / alveolar lavage fluid is also measured at these time points(tentatively
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Source(s) of Monetary Support
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Government, foundation, company
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Ethics review
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Status: Approved
Approval date: 29/02/2020
Contact:
whsjytyy_ec@163.com
Zhan Haiyan
+86 027-85509839
whsjytyy_ec@163.com
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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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