Coronavirus Disease 2019NCT04280913
Clinical Outcomes of Patients With COVID19
An observational study of Coronavirus Disease 2019, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronavirus Disease 2019
- What is being tested?
- retrospective analysis
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2020to 31 Mar 2020
- 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: This is a retrospective study of hospitalized patients with COVID19.
Who may be able to join
- Hospitalized patients with COVID19
Who cannot join
- Suspected patients with COVID19, not confirmed by the laboratory
- Patients who are refused to receive medical treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes of Hospitalized Patients With Coronavirus Disease 2019
As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.
- Conditions
- Coronavirus Disease 2019
- Being tested
- retrospective analysis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective analysisOther
The investigators retrospectively analyzed the hospitalized patients with COVID-19.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients | Hospitalized patients with COVID-19 Receives: Other: retrospective analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to negative conversion of severe acute respiratory syndrome coronavirus 2
The primary outcome is the time to negative conversion of coronavirus
Measured: 1 month
Secondary outcomes (3)
Length of stay in hospital
The time of hospitalization.
Measured: 1 month
Survival
The rate of survival within hospitalization of these patients will be tracked.
Measured: 1 month
Intubation
The rate of intubation within hospitalization of these patients will be tracked.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start22 Feb 2020
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Why it stopped: The research project was changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019Studies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Collaborators
- Huizhou Municipal Central Hospital
- Responsible party
- Principal investigator, LuQian Zhou, Guangzhou Institute of Respiratory Disease
- Investigators
- Luqian Zhou, MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280913
- Sponsor's protocol ID
- GZHZ-COVID19
- Status last verified
- Mar 2020
- First submitted
- 20 Feb 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Hospitalized Patients With Coronavirus Disease 2019
- ClinicalTrials.gov ID
- NCT04280913
- Acronym / sponsor ID
- GZHZ-COVID19
- Conditions
- Coronavirus Disease 2019
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The research project was changed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Collaborators
- Huizhou Municipal Central Hospital
- Study start
- 22 Feb 2020 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 21 Feb 2020 (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.
As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients | – | Other: retrospective analysisHospitalized patients with COVID-19 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a retrospective study of hospitalized patients with COVID19.
Key inclusion criteria (1 listed)
- Hospitalized patients with COVID19
Key exclusion criteria (2 listed)
- Suspected patients with COVID19, not confirmed by the laboratory
- Patients who are refused to receive medical treatments
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 |
|---|---|---|
| retrospective analysisThe investigators retrospectively analyzed the hospitalized patients with COVID-19. | Other | COVID-19 patients |
Primary outcome
Time to negative conversion of severe acute respiratory syndrome coronavirus 2
Time frame: 1 month
The primary outcome is the time to negative conversion of coronavirus
3 secondary outcomes
Length of stay in hospital
Time frame: 1 month
Survival
Time frame: 1 month
Intubation
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
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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.
Luqian Zhou, MD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
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 Coronavirus Disease 2019, run by Guangzhou Institute of Respiratory Disease 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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 19 Mar 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time to negative conversion of severe acute respiratory syndrome coronavirus 2 (time frame: 1 month). 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 19 Mar 2020.