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Sponsor R&D Strategy Adjustment
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This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 168 eligible patients with severe novel coronavirus pneumonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jaktinib 75mg BID | Experimental | Jaktinib 75mg BID |
|
| Jaktinib 100mg BID | Experimental | Jaktinib 100mg BID |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaktinib hydrochloride tablets | Drug | 75mg of Jaktinib administered orally Twice daily(BID) with best available treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of Participants who develop death or respiratory failure. | Respiratory failure is defined as Participants who on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation(ECMO) or on non-invasive ventilation or high-flow oxygen devices. | 28 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of Participants who develop death or respiratory failure. | Respiratory failure is defined as Participants who on invasive mechanical ventilation or ECMO or on non-invasive ventilation or high-flow oxygen devices. | 14 days after randomization |
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Inclusion Criteria:
Exclusion Criteria:
Participants who cannot take orally, or are suspected to be allergic to Jaktinib, similar drugs or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption;
Participants who have received the following treatments within the specified time window before randomization:
Immune deficiency;
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| Name | Affiliation | Role |
|---|---|---|
| Hongzhou Lu | The Third People Hospital of Shenzhen | Principal Investigator |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| Jaktinib hydrochloride tablets | Drug | 100mg of Jaktinib administered orally Twice daily(BID) with best available treatment. |
|
| Placebo | Other | Placebo (given as two placebo tablets) administered orally BID with best available treatment. |
|
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |