Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group:Intravenous drip, 0.2 g (4 vials) once daily for adults
slow drip after dilution with 250 ml of 5% Glucose Injection or 0.9% Sodium Chloride Injection, not less than 120 minutes or 30-40 drops/minute. Continuous administration for 7 days, observation until
Control group:Conventional treatment, no control drug
Sponsors
The Second Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Aged 18 years or older, male or female; (2) Real-time fluorescent RT-PCR of pharyngeal swab samples was positive for novel coronavirus nucleic acid; (3) Clinical classification is common or severe; (4) Signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Known or suspected allergy to the components of zedoary turmeric oil injection, or allergic constitution; (2) Mild and severe patients. (3) Combined with severe liver disease (such as Child-Pugh score >=C, TBIL >=2 times the upper limit of normal, ALT/AST >=5 times the upper limit of normal); (4) Combined with severe renal insufficiency (eGFR <=30 mL/min/1.73 m2) or undergoing continuous renal replacement therapy, hemodialysis, peritoneal dialysis; (5) Pregnant and lactating women or have fertility plans during the trial and within 6 months after the end of the trial; (6) Participated in other clinical trials within 3 months before enrollment; (7) According to the investigator's judgment, there are other conditions that are not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Real-time fluorescent RT-PCR detection of pharyngeal swab were used to detect the negative conversion rate of the new coronavirus nucleic acid (tested after the end of medication) and the negative conversion time(measured every other day after the start of medication, determined according to clinical needs);Time to clinical improvement;Change in size of lesion area by chest CT;Time to fever subsidence, defined as the time at which a subject with fever at enrollment has returned to normal temperature for at least 72 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Clinical recovery;Proportion of cases with disease progression;Cough disappearance rate and time;All-cause mortality;Changes of cytokines (IL-2, IL-4, IL-6, IL-10, IL-17, INF-gama, TNF-alpha);Markers of immune function: CD4 + and CD8 + T cell counts; | — |
Countries
China
Contacts
Public ContactYuanrong Dai
the Second Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed