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A randomized, double-blind, placebo parallel control study and is expected to enroll 20-60 eligible patients with severe novel coronavirus pneumonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jaktinib 100mg BID | Experimental | Jaktinib hydrochloride tablets, 2 x 50mg dosage, BID |
|
| Placebo | Placebo Comparator | 2 x Placebo tablets, BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaktinib hydrochloride tablets | Drug | 2 doses per day, 100mg Jaktinib |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Jaktinib | The proportion of subjects with disease progression or all-cause mortality | 28 days after randomization |
| Efficacy of Jaktinib | The proportion of subjects with disease progression or all-cause mortality | 14 days after randomization |
| Efficacy of Jaktinib | The proportion of subjects whose (National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS) score improved by ≥ 2 points from the baseline | 28 days after randomization |
| Efficacy of Jaktinib | The change value of NIAID-OS score compared with the baseline | 28 days after randomization |
| Efficacy of Jaktinib | Time interval from randomization to clinical improvement (defined as NIAID-OS 1-3 points) | Up to 28 days after randomization |
| Efficacy of Jaktinib | Time interval from randomization to discharge | Up to 28 days after randomization |
| Efficacy of Jaktinib | The proportion of subjects receiving mechanical ventilation due to disease progression at 3, 7, and 14 days after randomization until the end of treatment (EOT) | 28 days after randomization |
| Efficacy of Jaktinib |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Jaktinib | Incidence rate of adverse events and serious adverse events | Up to 2 months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
Participants who cannot take orally, or are suspected to be allergic to Jaktinib hydrochloride, similar drugs, or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption;
Critical pneumonia Participants with other organ failure requiring ICU monitoring and treatment;
Participants who have received the following treatments within the specified time window before randomization:
Immune deficiency;
Participants who have received the novel coronavirus vaccine within 1 week before randomization;
Prior to randomization, there were the following active and uncontrolled infections: tuberculosis, HIV, syphilis, mycoplasma, chlamydia, parasites, and viral infections other than SARS CoV-2 that required systemic anti-infection treatment;
Renal diseases requiring dialysis treatment;
Pregnant and lactating women;
Any other Participants that were considered unsuitable by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heng Li | Contact | +86 13787420314 | 87088945@qq.com | |
| XiaoLi Chai | Contact | +86 18674885619 | chaijin9@163.com |
| Name | Affiliation | Role |
|---|---|---|
| RongHu Li | Changsha Taihe Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changsha Taihe Hospital | Changsha | Hunan | China |
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| placebo |
| Drug |
2 doses per day, placebo |
|
The proportion of subjects whose chest High-Resolution CT (HRCT) showed significant absorption of pulmonary inflammation (definition of significant absorption: the lung inflammatory lesions were reduced by more than 50%) at 7, 14 days after treatment until EOT |
| 28 days after randomization |