Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
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
Sponsors
Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharynx swabs, lower respiratory tract samples (sputum/endotracheal aspiration/alveolar lavage), and anal swabs rt-pcr of novel coronavirus nucleic acid negative conversion rate.; | — |
Secondary
| Measure | Time frame |
|---|---|
| 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  | — |
Countries
China
Contacts
Public ContactZhang Dingyu
Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)
Outcome results
None listed