COVID-19NCT06142201
A Real-World Study of JT001 for COVID-19
An observational study of COVID-19, run by Shanghai Vinnerna Biosciences Co., Ltd. at 6 sites in China.
Trial summary
Real-world disease outcomes and safety in patients with mild to moderate COVID-19 treated with JT001 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- JT001
- Type of treatment
- Pill or oral medicine
- How many people
- 7,656 participants
- Where
- 6 sitesChina
- Study dates
- 31 Aug 2023to 31 Dec 2024
- Phase
- Observational
- 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
Study population: Adult patients with mild to moderate COVID-19
Who may be able to join
- Age ≥18 years old.
- The novel coronavirus infection (COVID-19) meets at least one of the following five criteria:
- 1) Diagnosis of novel coronavirus infection; 2) Diagnosed with novel coronavirus pneumonia; 3) The novel coronavirus nucleic acid test is positive; 4) Test positive for novel coronavirus antigen; 5) Culture positive for novel coronavirus.
- 3. Patients who have not developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, or who have developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, were treated with deuterimodivir hydrobromide tablets or were not treated with anti-novel coronavirus before disease progression.
Who cannot join
- Patients who have not developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, or those who have developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, received the following anti-novel coronavirus treatments before disease progression, including: Nematavir tablet/Ritonavir tablet, Azvudine tablet, Monoravir capsule, Zenotavir tablet/Ritonavir tablet, Leritvir tablet, Ambavirzumab/Romisivir injection, human immunoglobulin for COVID-19 or convalescent plasma for COVID-19 survivors.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Peking university first hospital
Beijing, Beijing Municipality, 100034
Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, 200000
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
Gongli Hospital, Pudong New Area, Shanghai
Shanghai, Shanghai Municipality, 200135
Central Hospital of Minhang District, Shanghai
Shanghai, Shanghai Municipality, 201100
Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
Shanghai, Shanghai Municipality, 201200
About this study
Official title: A Real-world Study：Disease Outcome and Safety of JT001 in Patients With Coronavirus Disease 2019 (COVID-19)
Real-world disease outcomes and safety in patients with mild to moderate COVID-19 treated with JT001
- Conditions
- COVID-19
- Being tested
- JT001
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JT001Drug
Also called DeuremidevirHydrobromideTablets
oral administration
| Study group | Role | What they receive |
|---|---|---|
| JT001 | Not described Receives: Drug: JT001 | |
| No anti-SARS-CoV-2 treatment | Not described Receives: Drug: JT001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of COVID-19 disease progression (severe COVID-19 or all-cause death) by day 28
Incidence of COVID-19 disease progression (severe COVID-19 or death from any cause) at day 28 from COVID-19 diagnosis. According to the diagnosis of severe COVID-19 and indicators meeting the diagnostic definition of severe COVID-19, the evaluation and analysis were performed.
Measured: Within 28 days
Secondary outcomes (3)
Incidence of the following COVID-19 disease progression events by day 28
Severe COVID-19 or all-cause death in patients with high-risk factors,Elderly patients (≥65 years) with severe COVID-19 or all-cause death,All enrolled patients had severe COVID-19,All enrolled patients died from all causes,COVID-19 related hospitalizations in non-hospitalized patients,Hospitalized patients with severe COVID-19 or all-cause death.
Measured: Within 28 days
Incidence of severe Covid-19-related events up to day 28
Incidence of severe Covid-19-related events up to day 28,Respiratory rate ≥30 times/min, Oxygen saturation (SpO2) ≤93% ,Partial oxygen pressure (PaO2)/Oxygen concentration (FiO2) ≤300mmHg,Lung imaging showed significant lesion progression > 50% within 24 to 48 hours,Mechanical ventilation o Respiratory failure and mechanical ventilation,Shock,Stay in ICU,Organ failure and admission to ICU.
Measured: Within 28 days
The incidence of all aes and abnormal laboratory changes on day 28, etc
The incidence of all aes and abnormal laboratory changes on day 28, etc
Measured: Within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start31 Aug 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 7,656 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142201
- Sponsor's protocol ID
- JT001-PMS-CO02-COVID-19
- Status last verified
- Aug 2024
- First submitted
- 20 Nov 2023
- Last updated
- 26 Aug 2024
- Results posted
- 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 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study：Disease Outcome and Safety of JT001 in Patients With Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT06142201
- Acronym / sponsor ID
- JT001-PMS-CO02-COVID-19
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,656 participants (actual)
- Lead sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Nov 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.
Real-world disease outcomes and safety in patients with mild to moderate COVID-19 treated with JT001
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JT001 | – | Drug: JT001 |
| No anti-SARS-CoV-2 treatment | – | Drug: JT001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with mild to moderate COVID-19
Key inclusion criteria (4 listed)
- Age ≥18 years old.
- The novel coronavirus infection (COVID-19) meets at least one of the following five criteria:
- 1) Diagnosis of novel coronavirus infection; 2) Diagnosed with novel coronavirus pneumonia; 3) The novel coronavirus nucleic acid test is positive; 4) Test positive for novel coronavirus antigen; 5) Culture positive for novel coronavirus.
- 3. Patients who have not developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, or who have developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, were treated with deuterimodivir hydrobromide tablets or were not treated with anti-novel coronavirus before disease progression.
Key exclusion criteria (1 listed)
- Patients who have not developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, or those who have developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, received the following anti-novel coronavirus treatments before disease progression, including: Nematavir tablet/Ritonavir tablet, Azvudine tablet, Monoravir capsule, Zenotavir tablet/Ritonavir tablet, Leritvir tablet, Ambavirzumab/Romisivir injection, human immunoglobulin for COVID-19 or convalescent plasma for COVID-19 survivors.
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 |
|---|---|---|
| JT001Also: DeuremidevirHydrobromideTabletsoral administration | Drug | JT001, No anti-SARS-CoV-2 treatment |
Primary outcome
Incidence of COVID-19 disease progression (severe COVID-19 or all-cause death) by day 28
Time frame: Within 28 days
Incidence of COVID-19 disease progression (severe COVID-19 or death from any cause) at day 28 from COVID-19 diagnosis. According to the diagnosis of severe COVID-19 and indicators meeting the diagnostic definition of severe COVID-19, the evaluation and analysis were performed.
3 secondary outcomes
Incidence of the following COVID-19 disease progression events by day 28
Time frame: Within 28 days
Incidence of severe Covid-19-related events up to day 28
Time frame: Within 28 days
The incidence of all aes and abnormal laboratory changes on day 28, etc
Time frame: Within 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Shanghai Vinnerna Biosciences Co., Ltd. at 6 sites 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 1 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 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
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?
Incidence of COVID-19 disease progression (severe COVID-19 or all-cause death) by day 28 (time frame: Within 28 days). 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 Aug 2024.