Novel COVID-19-Infected PneumoniaPhase 2COVID-19NCT05688839
A Study of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia
A Phase 2 study testing Jaktinib hydrochloride tablets in people with Novel COVID-19-Infected Pneumonia, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
A randomized, double-blind, placebo parallel control study and is expected to enroll 20-60 eligible patients with severe novel coronavirus pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Novel COVID-19-Infected Pneumonia
- 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
- 60 participants
- Where
- 1 siteChina
- Study dates
- Apr 2024to Mar 2025
- 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
- Aged ≥18 years old, regardless of gender;
- There is a history of novel coronavirus antigen- or nucleic acid-positive infection within 1-2 weeks;
- HRCT is consistent with the manifestation of viral pneumonia (judged by the investigator)
- Participants who voluntarily sign informed consent.
Who cannot join
- 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:
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Second Study to Assess the Efficacy and Safety of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia
A randomized, double-blind, placebo parallel control study and is expected to enroll 20-60 eligible patients with severe novel coronavirus pneumonia.
- Conditions
- Novel COVID-19-Infected Pneumonia
- Being tested
- Jaktinib hydrochloride tablets, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaktinib hydrochloride tabletsDrug
2 doses per day, 100mg Jaktinib
placeboDrug
2 doses per day, placebo
| Study group | Role | What they receive |
|---|---|---|
| Jaktinib 100mg BID | Experimental | Jaktinib hydrochloride tablets, 2 x 50mg dosage, BID Receives: Drug: Jaktinib hydrochloride tablets |
| Placebo | Placebo comparator | 2 x Placebo tablets, BID Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Jaktinib
The proportion of subjects with disease progression or all-cause mortality
Measured: 28 days after randomization
Efficacy of Jaktinib
The proportion of subjects with disease progression or all-cause mortality
Measured: 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
Measured: 28 days after randomization
Efficacy of Jaktinib
The change value of NIAID-OS score compared with the baseline
Measured: 28 days after randomization
Efficacy of Jaktinib
Time interval from randomization to clinical improvement (defined as NIAID-OS 1-3 points)
Measured: Up to 28 days after randomization
Efficacy of Jaktinib
Time interval from randomization to discharge
Measured: 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)
Measured: 28 days after randomization
Efficacy of Jaktinib
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
Measured: 28 days after randomization
Secondary outcomes (1)
Safety of Jaktinib
Incidence rate of adverse events and serious adverse events
Measured: Up to 2 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study startApr 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Novel COVID-19-Infected PneumoniaStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- RongHu Li, Principal investigator, Changsha Taihe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688839
- Sponsor's protocol ID
- ZGJAK-IIT-005
- Acronym
- COVID-19
- Status last verified
- Oct 2023
- First submitted
- 9 Jan 2023
- Last updated
- 24 Oct 2023
- 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 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Second Study to Assess the Efficacy and Safety of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia
- ClinicalTrials.gov ID
- NCT05688839
- Acronym / sponsor ID
- COVID-19 / ZGJAK-IIT-005
- Conditions
- Novel COVID-19-Infected Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 18 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.
A randomized, double-blind, placebo parallel control study and is expected to enroll 20-60 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Jaktinib 100mg BID | Experimental | Drug: Jaktinib hydrochloride tabletsJaktinib hydrochloride tablets, 2 x 50mg dosage, BID |
| Placebo | Placebo comparator | Drug: placebo2 x Placebo tablets, BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥18 years old, regardless of gender;
- There is a history of novel coronavirus antigen- or nucleic acid-positive infection within 1-2 weeks;
- HRCT is consistent with the manifestation of viral pneumonia (judged by the investigator)
- Participants who voluntarily sign informed consent.
Key exclusion criteria (11 listed)
- 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;
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 tablets2 doses per day, 100mg Jaktinib | Drug | Jaktinib 100mg BID |
| placebo2 doses per day, placebo | Drug | Placebo |
Primary outcome
Efficacy of Jaktinib
Time frame: 28 days after randomization
The proportion of subjects with disease progression or all-cause mortality
Efficacy of Jaktinib
Time frame: 14 days after randomization
The proportion of subjects with disease progression or all-cause mortality
Efficacy of Jaktinib
Time frame: 28 days after randomization
The proportion of subjects whose (National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS) score improved by ≥ 2 points from the baseline
Efficacy of Jaktinib
Time frame: 28 days after randomization
The change value of NIAID-OS score compared with the baseline
Efficacy of Jaktinib
Time frame: Up to 28 days after randomization
Time interval from randomization to clinical improvement (defined as NIAID-OS 1-3 points)
Efficacy of Jaktinib
Time frame: Up to 28 days after randomization
Time interval from randomization to discharge
Efficacy of Jaktinib
Time frame: 28 days after randomization
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)
Efficacy of Jaktinib
Time frame: 28 days after randomization
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
1 secondary outcome
Safety of Jaktinib
Time frame: Up to 2 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- 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.
RongHu Li principal investigator
Changsha Taihe Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Jaktinib hydrochloride tablets in people with Novel COVID-19-Infected Pneumonia, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heng Li (+86 13787420314, 87088945@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Jaktinib (time frame: 28 days after randomization). The study lists 8 primary outcomes in all. 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 24 Oct 2023.