COVID-19NCT05422963
Multiple-Center Retrospective Study of Severe and Critical COVID-19 in Shanghai
An observational study of COVID-19, run by Ruijin Hospital at 1 site in China.
Trial summary
This study is to clarify the clinical characteristics of severe and critical COVID-19 from March 1st ,2022 to June 9th, 2022 in Shanghai and to explore the relationship between the characteristics and prognosis in these patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2022to 10 Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: severe and critical COVID-19 patients admitted to specific medical systems in Shanghai.
Who may be able to join
- severe and critical covid-19 patients who met the "Diagnosis and Treatment Plan for new Coronavirus Pneumonia (Ninth Edition)"
- admission time more than 24 hours
Who cannot join
- admission time less than 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
This study is to clarify the clinical characteristics of severe and critical COVID-19 from March 1st ,2022 to June 9th, 2022 in Shanghai and to explore the relationship between the characteristics and prognosis in these patients.
Read the detailed description
- To Describe the clinical characteristics of severe and critical COVID-19.
- To analyze the relationship between the clinical characteristics and their clinical prognosis;
- To analyze the relationship between clinical intervention and their clinical prognosis.
- Conditions
- 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 |
|---|---|---|
| severe and critical COVID-19 | 1. hospital admission time more than 24 hours 2. meet the standard of definition of severe and critical COVID-19 in "Diagnosis and Treatment Plan for new Coronavirus Pneumonia (Ninth Edition)" |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
28-day mortality of severe and critical COVID-19
Measured: one year
Secondary outcomes (5)
60-day mortality
60-day mortality of severe and critical COVID-19
Measured: one year
ICU length of stay
ICU length of stay
Measured: one year
the percentage of organ failure
the percentage of organ failure include respiratory，circulatory failure and so on
Measured: one year
time for virus to turn negative
time for COVID-19 from positive to negative
Measured: one year
The overall description
The overall description of the clinical characteristics in severe and critical covid-19
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start10 Jun 2022 (estimated)
- Primary completion10 Jun 2023 (estimated)
- Study completion10 Jun 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.
- More trials run by Ruijin HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erzhen Chen, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422963
- Sponsor's protocol ID
- SCCS-2022-1
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data are not publicly available due to the privacy and ethical restriction.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-Center Retrospective Study of Severe and Critical COVID-19 in Shanghai
- ClinicalTrials.gov ID
- NCT05422963
- Acronym / sponsor ID
- SCCS-2022-1
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 10 Jun 2022 (estimated)
- Primary completion
- 10 Jun 2023 (estimated)
- Study completion
- 10 Jun 2023 (estimated)
- First posted
- 21 Jun 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.
This study is to clarify the clinical characteristics of severe and critical COVID-19 from March 1st ,2022 to June 9th, 2022 in Shanghai and to explore the relationship between the characteristics and prognosis in these patients.
Detailed description
- To Describe the clinical characteristics of severe and critical COVID-19.
- To analyze the relationship between the clinical characteristics and their clinical prognosis;
- To analyze the relationship between clinical intervention and their clinical prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe and critical COVID-19 | – | –1. hospital admission time more than 24 hours 2. meet the standard of definition of severe and critical COVID-19 in "Diagnosis and Treatment Plan for new Coronavirus Pneumonia (Ninth Edition)" |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- severe and critical COVID-19 patients admitted to specific medical systems in Shanghai.
Key inclusion criteria (2 listed)
- severe and critical covid-19 patients who met the "Diagnosis and Treatment Plan for new Coronavirus Pneumonia (Ninth Edition)"
- admission time more than 24 hours
Key exclusion criteria (1 listed)
- admission time less than 24 hours
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
28-day mortality
Time frame: one year
28-day mortality of severe and critical COVID-19
5 secondary outcomes
60-day mortality
Time frame: one year
ICU length of stay
Time frame: one year
the percentage of organ failure
Time frame: one year
time for virus to turn negative
Time frame: one year
The overall description
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: No. the data are not publicly available due to the privacy and ethical restriction.
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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.
Erzhen Chen, PhD principal investigator
Ruijin 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 Ruijin 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 2 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 21 Jun 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 Ying Chen, PhD (+8613917403314, cy11530@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: one year). 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 21 Jun 2022.