COVID-19NCT05374772
A Retrospective Study in Patients With Mild to Moderate COVID-19
An observational study of COVID-19, run by Shanghai Pudong Hospital at 1 site in China.
Trial summary
The purpose of this retrospective study is to analyze real-world disease progression in mild-moderate COVID-19 patients with at least one risk factor for serve COVID-19 illness or death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2022to 30 Apr 2023
- 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
- Adult, Older adult
Study population: Mild to Moderate COVID-19
Who may be able to join
- Participants who have a positive SARS-CoV-2 test result.
- Participants who have one or more mild or moderate COVID-19 symptoms.
- Participants who have one or more of the following requirements: ≤7 days from the first positive test for SARS-COV-2 virus infection to Day 1; ≤5 days from the first onset of COVID-19 symptoms to Day 1.
- Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death.
Who cannot join
- Participants who are diagnosed with severe/critical COVID-19 before Day 1.
- Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute before Day 1.
- Participants who have received mechanical ventilation before Day 1.
- Participants who have received or plan to receive a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) before and during hospitalization.
- Participants who have received convalescent COVID-19 plasma treatment before and during hospitalization.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality
Minghua Yu
About this study
Official title: A Retrospective, Real World Study to Analyze Disease Outcomes in Patients With Mild to Moderate Coronavirus Disease 2019 (COVID-19)
The purpose of this retrospective study is to analyze real-world disease progression in mild-moderate COVID-19 patients with at least one risk factor for serve COVID-19 illness or death.
Read the detailed description
This study is a retrospective, real world study, without any intervention in clinical diagnosis and treatment, and only real world data are collected for analysis.
The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
The study will collect and analyze available symptoms, risk factors and SARS-COV-2 Ct value up to 28 days.
- Conditions
- COVID-19
- Keywords
- Mild to Moderate COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient with COVID-19 | Mild to moderate COVID-19 patient with at least one risk factor for serve COVID-19 illness or death. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of the participants who have progression of COVID-19
Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause
Measured: Day 1 to 28 days
Percentage of participants who experience these events
Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause
Measured: Day 1 to 28 days
Secondary outcomes (7)
Time to sustained clinical recovery
Time to sustained clinical recovery
Measured: Up to 28 days
Time to sustained disappearance of clinical symptoms
Time to sustained disappearance of clinical symptoms
Measured: Up to 28 days
Time to initial negative conversion of SARS-COV-2
Time to initial negative conversion of SARS-COV-2
Measured: Up to 28 days
Time to sustained negative conversion of SARS-CoV-2
Time to sustained negative conversion of SARS-CoV-2
Measured: Up to 28 days
Percentage of participants who turned negative for SARS-CoV-2
Percentage of participants who turned negative for SARS-COV-2 at Day 3, 5, 7, 10, 14
Measured: Day 3, 5, 7, 10, 14
The change of SARS-COV-2 Ct value
The change of SARS-COV-2 Ct value The change of SARS-COV-2 Ct value at Day 3, 5, 7, 10, 14
Measured: Day 3, 5, 7, 10, 14
Safety assessment Results: such as AEs and SAEs through Day 28
Safety assessment Results: such as AEs and SAEs through Day 28
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start13 May 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minghua Yu, Principal investigator, Shanghai Pudong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374772
- Sponsor's protocol ID
- JT001-011-COVID-19
- Status last verified
- May 2022
- First submitted
- 13 May 2022
- Last updated
- 16 May 2022
- 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 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Real World Study to Analyze Disease Outcomes in Patients With Mild to Moderate Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT05374772
- Acronym / sponsor ID
- JT001-011-COVID-19
- Conditions
- COVID-19
- Keywords
- Mild to Moderate COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Pudong HospitalUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 16 May 2022 (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.
The purpose of this retrospective study is to analyze real-world disease progression in mild-moderate COVID-19 patients with at least one risk factor for serve COVID-19 illness or death.
Detailed description
This study is a retrospective, real world study, without any intervention in clinical diagnosis and treatment, and only real world data are collected for analysis.
The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
The study will collect and analyze available symptoms, risk factors and SARS-COV-2 Ct value up to 28 days.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with COVID-19 | – | –Mild to moderate COVID-19 patient with at least one risk factor for serve COVID-19 illness or death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Mild to Moderate COVID-19
Key inclusion criteria (4 listed)
- Participants who have a positive SARS-CoV-2 test result.
- Participants who have one or more mild or moderate COVID-19 symptoms.
- Participants who have one or more of the following requirements: ≤7 days from the first positive test for SARS-COV-2 virus infection to Day 1; ≤5 days from the first onset of COVID-19 symptoms to Day 1.
- Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death.
Key exclusion criteria (5 listed)
- Participants who are diagnosed with severe/critical COVID-19 before Day 1.
- Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute before Day 1.
- Participants who have received mechanical ventilation before Day 1.
- Participants who have received or plan to receive a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) before and during hospitalization.
- Participants who have received convalescent COVID-19 plasma treatment before and during hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of the participants who have progression of COVID-19
Time frame: Day 1 to 28 days
Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause
Percentage of participants who experience these events
Time frame: Day 1 to 28 days
Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause
7 secondary outcomes
Time to sustained clinical recovery
Time frame: Up to 28 days
Time to sustained disappearance of clinical symptoms
Time frame: Up to 28 days
Time to initial negative conversion of SARS-COV-2
Time frame: Up to 28 days
Time to sustained negative conversion of SARS-CoV-2
Time frame: Up to 28 days
Percentage of participants who turned negative for SARS-CoV-2
Time frame: Day 3, 5, 7, 10, 14
The change of SARS-COV-2 Ct value
Time frame: Day 3, 5, 7, 10, 14
Safety assessment Results: such as AEs and SAEs through Day 28
Time frame: Up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- 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.
Minghua Yu principal investigator
Shanghai Pudong Hospital
1 site 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 Pudong Hospital 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 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: status not confirmed, as of the sponsor's last update on 16 May 2022. 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. 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?
Contact Minghua Yu (+86-18017821601, minghua_md@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of the participants who have progression of COVID-19 (time frame: Day 1 to 28 days). The study lists 2 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 16 May 2022.