COVIDNCT04368871
Radiographic Findings and Their Temporal Changes in COVID-19 Positive Changes Patients: A Prospective Study
An observational study of COVID, run by Max Healthcare Insititute Limited at 1 site in India.
Trial summary
All Patient irrespective of age with confirmed COVID-19 admitted to hospital and who underwent chest radiograph will be enrolled in the study to find raduigraphic findings and their temporal changes in COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 28 Apr 2020to 30 May 2021
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: the study population will include all the COVID-19 pateints of Max Super speciality Hospital, New Delhi, India, all males and females with minimum age 18 years old and who underwent Chest radiograph will be included in the study
Who may be able to join
- 1.Patients confirmed positive for COVID-19 by rRT-PCR irrespective of age.
Who cannot join
- 1.Patients with flu like symptoms but negative for COVID-19 by rRT-PCR.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Max Super Speciality Hospital, A Unit of Devki Devi Foundation
New Delhi, 110017
Rajesh Saxena, 9818474003, Rajesh.Saxena@maxhealthcare.com
About this study
All Patient irrespective of age with confirmed COVID-19 admitted to hospital and who underwent chest radiograph will be enrolled in the study to find raduigraphic findings and their temporal changes in COVID-19.
Read the detailed description
In this prospective trial the investigator will work on radiology findings and their temporal changes in COVID-19 positive patients and who underwent chest radiograph will be enrolled in our study.
Patient selection will be consecutive in addition of age , gender and comorbid conditions clinical information will included travel,expose and contact history. All patients should be positive for COVID-19 via laboratory testing with real time reverse transcriptase polymerase chain reaction(rRT-PCR) In addition, the number of rRT-PCR tests performed on each patient, on which test a positive result was found,and the number of days between symptomology onset and date of first positive test will be recorded.
In view of the current dynamics, any other reliable diagnostic test(s) if added to the clinical protocol will also be considered for inclusion in this study.
Tabulation of radiographic findings for all consecutive X-rays will be done along with the temporal changes of these findings. further, the clinical findings with the outcomes(duration of hospital findings, ventilatory support and discharge/death).
- Conditions
- COVID
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic findings and their temporal changes in COVID-19 positive patient: A Prospective study
Determine the radiographic findings in chest X-ray of COVID-19 positive patients.
Measured: 1-2 weeks
Secondary outcomes (1)
Radiographic findings and their temporal changes in COVID-19 positive patient: A Prospective study
Correlation of clinical findings with the outcomes (duration of hospital stay, ventilatory support, and discharge/death)
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start28 Apr 2020
- Primary completion30 Jun 2020 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max Healthcare Insititute Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368871
- Sponsor's protocol ID
- Covid-19/RFTC/MHC/2020
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing protocol is undecided at this stage. We may, however, provide data if required
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Findings and Their Temporal Changes in COVID-19 Positive Changes Patients: A Prospective Study
- ClinicalTrials.gov ID
- NCT04368871
- Acronym / sponsor ID
- Covid-19/RFTC/MHC/2020
- Conditions
- COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Max Healthcare Insititute LimitedUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 30 Apr 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.
All Patient irrespective of age with confirmed COVID-19 admitted to hospital and who underwent chest radiograph will be enrolled in the study to find raduigraphic findings and their temporal changes in COVID-19.
Detailed description
In this prospective trial the investigator will work on radiology findings and their temporal changes in COVID-19 positive patients and who underwent chest radiograph will be enrolled in our study.
Patient selection will be consecutive in addition of age , gender and comorbid conditions clinical information will included travel,expose and contact history. All patients should be positive for COVID-19 via laboratory testing with real time reverse transcriptase polymerase chain reaction(rRT-PCR) In addition, the number of rRT-PCR tests performed on each patient, on which test a positive result was found,and the number of days between symptomology onset and date of first positive test will be recorded.
In view of the current dynamics, any other reliable diagnostic test(s) if added to the clinical protocol will also be considered for inclusion in this study.
Tabulation of radiographic findings for all consecutive X-rays will be done along with the temporal changes of these findings. further, the clinical findings with the outcomes(duration of hospital findings, ventilatory support and discharge/death).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the study population will include all the COVID-19 pateints of Max Super speciality Hospital, New Delhi, India, all males and females with minimum age 18 years old and who underwent Chest radiograph will be included in the study
Key inclusion criteria (1 listed)
- 1.Patients confirmed positive for COVID-19 by rRT-PCR irrespective of age.
Key exclusion criteria (1 listed)
- 1.Patients with flu like symptoms but negative for COVID-19 by rRT-PCR.
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
Radiographic findings and their temporal changes in COVID-19 positive patient: A Prospective study
Time frame: 1-2 weeks
Determine the radiographic findings in chest X-ray of COVID-19 positive patients.
1 secondary outcome
Radiographic findings and their temporal changes in COVID-19 positive patient: A Prospective study
Time frame: 4-8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: Undecided. IPD sharing protocol is undecided at this stage. We may, however, provide data if required
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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.
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, run by Max Healthcare Insititute Limited 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: status not confirmed, as of the sponsor's last update on 9 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bharat Aggarwal (9810077484, Bharat.Aggarwal@maxhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic findings and their temporal changes in COVID-19 positive patient: A Prospective study (time frame: 1-2 weeks). 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 9 Jun 2020.