Novel Coronavirus Infected (COVID-19)
Conditions
Interventions
Oral leflunomide + Symptomatic treatment group:Oral leflunomide + Symptomatic treatment
Symptomatic treatment group:Symptomatic treatment
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and female, aged 18-70 years; 2. Novel coronavirus nucleic acid or antigen test positive; 3. The diagnostic criteria for confirmed cases in the national COVID-19 Protocol (Tenth edition) were met; 4. Onset within 5 days; 5. The informed consent is signed by patients or their authorized agent; 6. Subjects who may or receive oral medication; 7. Agree to collect clinical samples; 8. Female subjects of reproductive age were not pregnant and agreed to use effective contraception within 7 days of the last oral medication to ensure non-pregnancy; 9. The men agreed not to cohabit with the woman for seven days after the last oral medication.
Exclusion criteria
Exclusion criteria: 1. Severe vomiting and difficulty in taking or ingestion of oral medication; 2. Pregnant and lactating women; 3. People with mental illness and cognitive impairment; 4. Subjects received antiviral drugs (including nirmatrelvir /ritonavir, azulfidine, molnupiravir, monoclonal antibodies) in 5 days before admission; 5. Cases of respiratory failure requiring mechanical ventilation; 6. There were cases of shock; 7. ICU care is required for other organ failure; 8. Patients who were clinically predicted to have no hope of survival and were placed on hospice care only, or those who were in a deep coma and did not respond to supportive treatment within three hours of admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time for viral nucleic acid to turn negative; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who progress to severe disease;Duration of fever;C reactive protein concentration in peripheral blood;Absolute value and percentage of peripheral blood lymphocytes;Time of improvement of chest imaging;The time of sustained clinical recovery; | — |
Countries
China
Contacts
Public ContactHu Ke
Renmin Hospital of Wuhan University
Outcome results
None listed