COVID-19 PandemicNCT06528119
The Combined Usage of Clinical Physical Finding in Management of COVID 19 Patients
An observational study of COVID-19 Pandemic, run by St. Martin De Porress Hospital at 1 site in Taiwan.
Trial summary
Physiological indicators such as blood pressure, heart rate, respiratory rate, and consciousness status of COVID-19 patients are used to apply the START (simple triage and rapid treatment, START), Modified Early Warning Score (MEWS), and quick Sequential Organ Failure Assessment (qSOFA) as tools for assessing clinical… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- COVID 19 pandemic
- How many people
- 10,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Sep 2020to 20 Jul 2024
- How long will I take part?
- 6 Months
- 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: COVID 19 patients were treated in the hospital between March 2020 and Sep.2022
Who may be able to join
- a group of hospitalized COVID 19 patients were treated in the hospital between March 2020 and Sep.2022
- Exclusion Criteria: Exclude patients who lack information in their medical records and incomplete clinical data.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Combined Usage of Clinical Physical Finding With Simple Triage and Rapid Treatment (START), Modified Early Warning Score(MEWS)and Quick Sequential Organ Failure Assessment(qSOFA) in Management of COVID 19 Patients
Physiological indicators such as blood pressure, heart rate, respiratory rate, and consciousness status of COVID-19 patients are used to apply the START (simple triage and rapid treatment, START), Modified Early Warning Score (MEWS), and quick Sequential Organ Failure Assessment (qSOFA) as tools for assessing clinical symptom tracking, deterioration, and subsequent improvement in COVID-19 patients. In response to the need for scarce manpower when a large number of emergency patients appear, a simple and easy-to-operate assessment method is adopted for mild patients, and artificial intelligence technology can be further used to assist in the assessment for early response and medication.
Read the detailed description
Due to the development of the pandemic , the virus has constantly mutated, leading to a vast majority of mild cases. This has significantly increased the burden on medical personnel. The investigators are trying to find a way to track whether their clinical symptoms have worsened. At the same time, the investigators want to know the changes in patient symptoms in real-time through online monitoring This is a single-center retrospective study of a group of COVID-19 patients. Review their medical records, mainly based on hospital field records and existing physiological indicators of patients such as blood pressure, heart rate, respiratory rate, and consciousness status. The partients visited the hospital between March 2020 and September 2022. All patients were given physiological value indicators MEWS, qSOFA, and START for scoring and assess the clinical symptom deterioration of COVID-19 patients.
In this study, The investigators collect the physiological values of each patient and the data on the nursing records during hospitalization to judge whether the symptoms have worsened
- Conditions
- COVID-19 Pandemic
- Being tested
- COVID 19 pandemic
- Keywords
- blood pressure, heart rate, respiratory rate, consciousness status, quick Sequential Organ Failure Assessment (qSOFA)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID 19 pandemicOther
Physiological indicators such as blood pressure, heart rate, respiratory rate, and consciousness status of COVID-19 patients are used to apply the START, MEWS, and qSOFA in COVID-19 patients.(COVID 19 病患).
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID 19 pandemic
Assessing clinical symptom tracking, deterioration, and subsequent improvement in COVID-19 patients.
Measured: March 2020 and September 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start30 Sep 2020
- Primary completion1 May 2022
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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
- Other
- Enrolment
- 10,000 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- St. Martin De Porress Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-hsi Chen, St. Martin De Porress Hospital
- Investigators
- Chia-Hsi Chen, MD, Principal investigator, St. Martin De Porres Hospital,emergency medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528119
- Sponsor's protocol ID
- 22B-005
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Usage of Clinical Physical Finding With Simple Triage and Rapid Treatment (START), Modified Early Warning Score(MEWS)and Quick Sequential Organ Failure Assessment(qSOFA) in Management of COVID 19 Patients
- ClinicalTrials.gov ID
- NCT06528119
- Acronym / sponsor ID
- 22B-005
- Conditions
- COVID-19 Pandemic
- Keywords
- blood pressure, heart rate, respiratory rate, consciousness status, quick Sequential Organ Failure Assessment (qSOFA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- St. Martin De Porress HospitalUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 30 Jul 2024 (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.
Physiological indicators such as blood pressure, heart rate, respiratory rate, and consciousness status of COVID-19 patients are used to apply the START (simple triage and rapid treatment, START), Modified Early Warning Score (MEWS), and quick Sequential Organ Failure Assessment (qSOFA) as tools for assessing clinical symptom tracking, deterioration, and subsequent improvement in COVID-19 patients. In response to the need for scarce manpower when a large number of emergency patients appear, a simple and easy-to-operate assessment method is adopted for mild patients, and artificial intelligence technology can be further used to assist in the assessment for early response and medication.
Detailed description
Due to the development of the pandemic , the virus has constantly mutated, leading to a vast majority of mild cases. This has significantly increased the burden on medical personnel. The investigators are trying to find a way to track whether their clinical symptoms have worsened. At the same time, the investigators want to know the changes in patient symptoms in real-time through online monitoring This is a single-center retrospective study of a group of COVID-19 patients. Review their medical records, mainly based on hospital field records and existing physiological indicators of patients such as blood pressure, heart rate, respiratory rate, and consciousness status. The partients visited the hospital between March 2020 and September 2022. All patients were given physiological value indicators MEWS, qSOFA, and START for scoring and assess the clinical symptom deterioration of COVID-19 patients.
In this study, The investigators collect the physiological values of each patient and the data on the nursing records during hospitalization to judge whether the symptoms have worsened
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- COVID 19 patients were treated in the hospital between March 2020 and Sep.2022
Key inclusion criteria (3 listed)
- a group of hospitalized COVID 19 patients were treated in the hospital between March 2020 and Sep.2022
- Exclusion Criteria: Exclude patients who lack information in their medical records and incomplete clinical data.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| COVID 19 pandemicPhysiological indicators such as blood pressure, heart rate, respiratory rate, and consciousness status of COVID-19 patients are used to apply the START, MEWS, and qSOFA in COVID-19 patients.(COVID 19 病患). | Other | – |
Primary outcome
COVID 19 pandemic
Time frame: March 2020 and September 2022
Assessing clinical symptom tracking, deterioration, and subsequent improvement in COVID-19 patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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.
Chia-Hsi Chen, MD principal investigator
St. Martin De Porres Hospital,emergency medicine
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 Pandemic, run by St. Martin De Porress Hospital at 1 site in Taiwan.
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 3 inclusion and 0 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: finished, as of the sponsor's last update on 1 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 1 site in Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
COVID 19 pandemic (time frame: March 2020 and September 2022). 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 1 Aug 2024.