COVID-19Phase 2COVID-19NCT05702788
Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)
A Phase 2 study testing Jaktinib hydrochloride tablets in people with COVID-19 and Pneumonia, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd.
Trial summary
This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 168 eligible patients with severe novel coronavirus pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Jaktinib hydrochloride tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to 23 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Study to Evaluate the Efficacy and Safety of Jaktinib Hydrochloride Tablets in Participants Receiving the Best Available Treatment for Severe Novel Coronavirus Pneumonia
This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 168 eligible patients with severe novel coronavirus pneumonia.
- Being tested
- Jaktinib hydrochloride tablets, Placebo
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaktinib hydrochloride tabletsDrug
75mg of Jaktinib administered orally Twice daily(BID) with best available treatment.
Jaktinib hydrochloride tabletsDrug
100mg of Jaktinib administered orally Twice daily(BID) with best available treatment.
PlaceboOther
Placebo (given as two placebo tablets) administered orally BID with best available treatment.
| Study group | Role | What they receive |
|---|---|---|
| Jaktinib 75mg BID | Experimental | Jaktinib 75mg BID Receives: Drug: Jaktinib hydrochloride tablets |
| Jaktinib 100mg BID | Experimental | Jaktinib 100mg BID Receives: Drug: Jaktinib hydrochloride tablets |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days after randomization
Secondary outcomes (1)
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.
Measured: 14 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study startSep 2022 (estimated)
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Why it stopped: Sponsor R\&D Strategy Adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongzhou Lu, Principal investigator, The Third People Hospital of Shenzhen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702788
- Sponsor's protocol ID
- ZGJAK032
- Acronym
- COVID-19
- Status last verified
- Apr 2024
- First submitted
- 18 Jan 2023
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Study to Evaluate the Efficacy and Safety of Jaktinib Hydrochloride Tablets in Participants Receiving the Best Available Treatment for Severe Novel Coronavirus Pneumonia
- ClinicalTrials.gov ID
- NCT05702788
- Acronym / sponsor ID
- COVID-19 / ZGJAK032
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor R\&D Strategy Adjustment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 168 eligible patients with severe novel coronavirus pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Jaktinib 75mg BID | Experimental | Drug: Jaktinib hydrochloride tabletsJaktinib 75mg BID |
| Jaktinib 100mg BID | Experimental | Drug: Jaktinib hydrochloride tabletsJaktinib 100mg BID |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jaktinib hydrochloride tablets75mg of Jaktinib administered orally Twice daily(BID) with best available treatment. | Drug | Jaktinib 75mg BID |
| Jaktinib hydrochloride tablets100mg of Jaktinib administered orally Twice daily(BID) with best available treatment. | Drug | Jaktinib 100mg BID |
| PlaceboPlacebo (given as two placebo tablets) administered orally BID with best available treatment. | Other | Placebo |
Primary outcome
The proportion of Participants who develop death or respiratory failure.
Time frame: 28 days after randomization
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.
1 secondary outcome
The proportion of Participants who develop death or respiratory failure.
Time frame: 14 days after randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongzhou Lu principal investigator
The Third People Hospital of Shenzhen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Jaktinib hydrochloride tablets in people with COVID-19 and Pneumonia, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of Participants who develop death or respiratory failure. (time frame: 28 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.