COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT05702788


Column Value
Trial registration number NCT05702788
Full text link
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05702788

First author
Last imported at : March 30, 2023, 4 a.m.
Source : ClinicalTrials.gov

Zhentian Zhao

Contact
Last imported at : March 30, 2023, 4 a.m.
Source : ClinicalTrials.gov

zhaozt@zelgen.com

Registration date
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

2023-01-27

Recruitment status
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 28, 2023, 8 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. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : March 30, 2023, 4 a.m.
Source : ClinicalTrials.gov

inclusion criteria: 18 years of age, male or female; the participants was diagnosed with novel coronavirus pneumonia; it meets the heavy-duty standards of the new coronavirus pneumonia diagnosis and treatment protocol (version 9). participants who voluntarily sign informed consent. the national institute of allergy and infectious diseases sequential scale (niaid-0s) score is 5 or 6;

Exclusion criteria
Last imported at : March 30, 2023, 4 a.m.
Source : ClinicalTrials.gov

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: 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;

Number of arms
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Inclusion age min
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

China

Type of patients
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

168

primary outcome
Last imported at : March 30, 2023, 4 a.m.
Source : ClinicalTrials.gov

The proportion of Participants who develop death or respiratory failure.

Notes
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Jan. 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "75 mg", "treatment_id": 2679, "treatment_name": "Jaktinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "100 mg", "treatment_id": 2679, "treatment_name": "Jaktinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]