COVID-19 Pneumonia
Conditions
Keywords
Pneumonia, COVID-19 Infection
Brief summary
This was a randomized, double-blind, placebo-controlled parallel study.
Interventions
100mg of Jaktinib (given as two 50mg tablets) administered orally Twice daily(BID) with best available treatment.
Placebo (given as two placebo tablets) administered orally BID with best available treatment.
Sponsors
Study design
Eligibility
Inclusion criteria
* 18 years of age, male or female; * History of COVID-19 infection within 1 week; * Subjects with HRCT consistent with viral pneumonia (Judged by investigator) and meeting any of the following criteria: With fever, respiratory symptoms; Shortness of breath present,RR ≥30 breaths/min. * Clear consciousness, Capable and voluntary informed consent.
Exclusion criteria
* Unable to take tablets orally Or suspected hypersensitivity to Jaktinib, drugs of the same class, or their excipients, Patients with severe gastrointestinal dysfunction affecting drug absorption; * Any person meeting criteria for critical pneumonia; * Patients considered unsuitable for this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Recovery | Day 1 to Day 28 | Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. NIAID-OS: 1 Not hospitalized, no limitations on activities. 2 Not hospitalized, limitation on activities and/or requiring home oxygen. 3 Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who require invasive mechanical ventilation due to disease progression at Day 3, 7, 1 4 or EOT | Day 3, 7, 14 or EOT | — |
| Mortality | Day 1 to Day 28 | Proportion of patients with all-cause mortality at Day 28 |
Countries
China