All Patients Undergoing COVID 19 Specific TestingNCT04974177
A Study to Determine the Role of Physician Gestalt in Predicting COVID-19 in Patients
An observational study of All Patients Undergoing COVID 19 Specific Testing, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
Trial summary
THIS IS A PROSPECTIVE OBSERVATIONAL STUDY TO DETERMINE THE ROLE OF PHYSICIAN GESTALT IN CLINICAL PREDICTION OF COVID 19. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- All Patients Undergoing COVID 19 Specific Testing
- How many people
- 876 participants
- Where
- 1 siteIndia
- Study dates
- 15 Mar 2021to 15 Sep 2022
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients presenting to ED, who undergo COVID 19 specific testing.
Who may be able to join
- All patients presenting to ED, who undergo COVID 19 specific testing.
Who cannot join
- Patients with active COVID 19 disease diagnosed outside All brought dead cases. All patients not consenting to take part in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Study to Determine the Role of Physician Gestalt in Clinical Prediction of COVID-19
THIS IS A PROSPECTIVE OBSERVATIONAL STUDY TO DETERMINE THE ROLE OF PHYSICIAN GESTALT IN CLINICAL PREDICTION OF COVID 19.
Read the detailed description
Among patients attending the Emergency Department, prompt identification of possible cases of COVID 19 is important to avoid the spread. An immediate clinical diagnosis is important for point of care decision making on choice of treatment facility as well as for triaging, testing and to quarantine patients admitted to the hospital from emergency room. Hence this study attempts to find out the role of physician gestalt in early diagnosis and differentiation of COVID 19.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, positive and negative likelihood ratio of physician gestalt in diagnosis of COVID 19 in patients presenting to ED who are being sent for COVID 19 specific testing.
Measured: march 2021- september 2022
Secondary outcomes (1)
Sensitivity, specificity, positive and negative likelihood ratio of clinical and epidemiological variables in patients presenting to ED who are being sent for COVID 19 specific testing.
Measured: march 2021- september 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start15 Mar 2021
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Patients Undergoing COVID 19 Specific TestingStudies 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
- Prospective
- Enrolment
- 876 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jubilee Mission Medical College and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SARASWATHY M, Jubilee Mission Medical College and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974177
- Sponsor's protocol ID
- 13/21/IEC/JMMC&RI
- Status last verified
- Mar 2024
- First submitted
- 21 Jul 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Determine the Role of Physician Gestalt in Clinical Prediction of COVID-19
- ClinicalTrials.gov ID
- NCT04974177
- Acronym / sponsor ID
- 13/21/IEC/JMMC&RI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 876 participants (actual)
- Lead sponsor
- Jubilee Mission Medical College and Research InstituteUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 23 Jul 2021 (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 IS A PROSPECTIVE OBSERVATIONAL STUDY TO DETERMINE THE ROLE OF PHYSICIAN GESTALT IN CLINICAL PREDICTION OF COVID 19.
Detailed description
Among patients attending the Emergency Department, prompt identification of possible cases of COVID 19 is important to avoid the spread. An immediate clinical diagnosis is important for point of care decision making on choice of treatment facility as well as for triaging, testing and to quarantine patients admitted to the hospital from emergency room. Hence this study attempts to find out the role of physician gestalt in early diagnosis and differentiation of COVID 19.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients presenting to ED, who undergo COVID 19 specific testing.
Key inclusion criteria (1 listed)
- All patients presenting to ED, who undergo COVID 19 specific testing.
Key exclusion criteria (1 listed)
- Patients with active COVID 19 disease diagnosed outside All brought dead cases. All patients not consenting to take part in the study.
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
Sensitivity, specificity, positive and negative likelihood ratio of physician gestalt in diagnosis of COVID 19 in patients presenting to ED who are being sent for COVID 19 specific testing.
Time frame: march 2021- september 2022
1 secondary outcome
Sensitivity, specificity, positive and negative likelihood ratio of clinical and epidemiological variables in patients presenting to ED who are being sent for COVID 19 specific testing.
Time frame: march 2021- september 2022
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 13 Mar 2024.
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.
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 All Patients Undergoing COVID 19 Specific Testing, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
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 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: finished, as of the sponsor's last update on 13 Mar 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 India. 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?
Sensitivity, specificity, positive and negative likelihood ratio of physician gestalt in diagnosis of COVID 19 in patients presenting to ED who are being sent for COVID 19 specific testing. (time frame: march 2021- 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 13 Mar 2024.