COVID-19 PneumoniaPhase 2NCT05672888
Efficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.
A Phase 2 study testing Jaktinib in people with COVID-19 Pneumonia, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This was a randomized, double-blind, placebo-controlled parallel study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Jaktinib
- 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
- Mar 2023to May 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;
- History of COVID-19 infection within 1 week;
- Subjects with HRCT consistent with viral pneumonia (Judged by investigator) and meeting any of the following criteria: With fever, respiratory symptoms; Shortness of breath present,RR ≥30 breaths/min.
- Clear consciousness, Capable and voluntary informed consent.
Who cannot join
- Unable to take tablets orally Or suspected hypersensitivity to Jaktinib, drugs of the same class, or their excipients, Patients with severe gastrointestinal dysfunction affecting drug absorption;
- Any person meeting criteria for critical pneumonia;
- Patients considered unsuitable for this trial by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000
Jianya Zhou
About this study
This was a randomized, double-blind, placebo-controlled parallel study.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Jaktinib, Placebo
- Keywords
- Pneumonia, COVID-19 Infection
- Medical subject headings
- Pneumonia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JaktinibDrug
100mg of Jaktinib (given as two 50mg tablets) administered orally Twice daily(BID) with best available treatment.
PlaceboDrug
Placebo (given as two placebo tablets) administered orally BID with best available treatment.
| Study group | Role | What they receive |
|---|---|---|
| Jaktinib | Experimental | Jaktinib 100mg BID Receives: Drug: Jaktinib |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Recovery
Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. NIAID-OS: 1 Not hospitalized, no limitations on activities. 2 Not hospitalized, limitation on activities and/or requiring home oxygen. 3 Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care.
Measured: Day 1 to Day 28
Secondary outcomes (2)
Percentage of participants who require invasive mechanical ventilation due to disease progression at Day 3, 7, 1 4 or EOT
Measured: Day 3, 7, 14 or EOT
Mortality
Proportion of patients with all-cause mortality at Day 28
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study startMar 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianya Zhou, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672888
- Sponsor's protocol ID
- ZGJAK-IIT-002
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 17 Jan 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 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.
- ClinicalTrials.gov ID
- NCT05672888
- Acronym / sponsor ID
- ZGJAK-IIT-002
- Conditions
- COVID-19 Pneumonia
- Keywords
- Pneumonia, COVID-19 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 5 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 was a randomized, double-blind, placebo-controlled parallel study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jaktinib | Experimental | Drug: JaktinibJaktinib 100mg BID |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age, male or female;
- History of COVID-19 infection within 1 week;
- Subjects with HRCT consistent with viral pneumonia (Judged by investigator) and meeting any of the following criteria: With fever, respiratory symptoms; Shortness of breath present,RR ≥30 breaths/min.
- Clear consciousness, Capable and voluntary informed consent.
Key exclusion criteria (3 listed)
- Unable to take tablets orally Or suspected hypersensitivity to Jaktinib, drugs of the same class, or their excipients, Patients with severe gastrointestinal dysfunction affecting drug absorption;
- Any person meeting criteria for critical pneumonia;
- Patients considered unsuitable for this trial by the investigator.
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 |
|---|---|---|
| Jaktinib100mg of Jaktinib (given as two 50mg tablets) administered orally Twice daily(BID) with best available treatment. | Drug | Jaktinib |
| PlaceboPlacebo (given as two placebo tablets) administered orally BID with best available treatment. | Drug | Placebo |
Primary outcome
Time to Recovery
Time frame: Day 1 to Day 28
Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. NIAID-OS: 1 Not hospitalized, no limitations on activities. 2 Not hospitalized, limitation on activities and/or requiring home oxygen. 3 Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care.
2 secondary outcomes
Percentage of participants who require invasive mechanical ventilation due to disease progression at Day 3, 7, 1 4 or EOT
Time frame: Day 3, 7, 14 or EOT
Mortality
Time frame: Day 1 to Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 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.
Jianya Zhou principal investigator
First Affiliated Hospital of Zhejiang University
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 in people with COVID-19 Pneumonia, run by First Affiliated Hospital of Zhejiang University 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 3 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 17 Jan 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 Jianya Zhou (0571-87235114, zhoujianya@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Recovery (time frame: Day 1 to Day 28). 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 17 Jan 2023.