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| Column | Value |
|---|---|
| Trial registration number | NCT05686629 |
|
Full text link
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
luozhu720@163.com |
|
Registration date
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
2023-01-17 |
|
Recruitment status
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : March 25, 2023, 8 p.m. Source : ClinicalTrials.gov |
inclusion criteria: aged 18 to 80 years old (including threshold), regardless of gender; there is a history of novel coronavirus antigen- or nucleic acid-positive infection within 1 week; hrct is consistent with the manifestation of viral pneumonia (judged by the investigator) participants who voluntarily sign informed consent. |
|
Exclusion criteria
Last imported at : March 25, 2023, 8 p.m. Source : ClinicalTrials.gov |
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 patients with other organ failure requiring icu monitoring and treatment; participants who have received the following treatments within the specified time window before randomization: participants have received janus kinase (jak) inhibitor, interleukin 6 (il-6) inhibitor, il-1 inhibitor, tumor necrosis factor (tnf) inhibitor, t cell or b cell depletion agent, interferon and other immunosuppressive drugs within the first two weeks of randomization, except glucocorticoid; systematically used cyp 3a4 potent inhibitor or potent inducer in the first five drug half lives at random; immune deficiency; participants who have received 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. |
|
Number of arms
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
|
Inclusion age min
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
80 |
|
Countries
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
Severe disease at enrollment |
|
Severity scale
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
6: Severe disease at enrollment |
|
Total sample size
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
120 |
|
primary outcome
Last imported at : March 25, 2023, 8 p.m. Source : ClinicalTrials.gov |
Efficacy of Jaktinib;Efficacy of Jaktinib;Efficacy of Jaktinib;Efficacy of Jaktinib;Efficacy of Jaktinib;Efficacy of Jaktinib;Efficacy of Jaktinib;Time interval from randomization to discharge |
|
Notes
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Jan. 19, 2023, 4 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 2679, "treatment_name": "Jaktinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |