Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group :Oral leflunomide
Control group:Oral placebo
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-70 years male or female; 2. 2019 new coronavirus nucleic acid test positive; 3. meet the national diagnosis criteria; 4. subjects onset within 8 days (severe cases can be delayed to 14 days); 5. subjects or agency personnel agree to sign the informed consent; 6. subjects who can take oral medication or who receive oral medication; 7. subjects agree to collect clinical samples; 8. female subjects of child-bearing age are not pregnant and agree to take effective contraceptive measures within 7 days of the last oral medication to ensure that they will not pregnant; 9. men agree not to have sex with women for seven days after taking their last oral medication.
Exclusion criteria
Exclusion criteria: 1. severe vomiting and difficulty in taking oral medication or absorbing in oral medication; 2. pregnant and nursing women; 3. subjects received lopinavir/ridonavir, ribavirin, monoclonal antibodies and other specific antiviral drugs in the week prior to admission; 4. subjects exist respiratory failure requiring mechanical ventilation; 5. subjects of shock; 6. subjects combined with other organ failure requires intensive care unit; 7. subjects with no clinical expectation of survival and only give end-of-life care, or those in a deep coma who did not respond to supportive treatment within three hours of admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The days from positive to negative for viral nucleic acid testing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of progress to severe illness;Duration of fever;C reactive protein concentration in peripheral blood;Absolute value and percentage of lymphocytes in peripheral blood;Time of pulmonary imaging remission; | — |
Countries
China
Contacts
Public ContactKe Hu
Renmin Hospital of Wuhan University
Outcome results
None listed