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Radiographic Findings and Their Temporal Changes in COVID-19 Positive Changes Patients: A Prospective Study

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ClinicalTrials.gov Identifier: NCT04368871
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Max Healthcare Insititute Limited

Brief 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.

Condition or disease
COVID

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).

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radiographic Findings and Their Temporal Changes in COVID-19 Positive Changes Patients: A Prospective Study
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : May 30, 2021



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Radiographic findings and their temporal changes in COVID-19 positive patient: A Prospective study [ Time Frame: 4-8 weeks ]
    Correlation of clinical findings with the outcomes (duration of hospital stay, ventilatory support, and discharge/death)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

1.Patients confirmed positive for COVID-19 by rRT-PCR irrespective of age.

Exclusion Criteria:

1.Patients with flu like symptoms but negative for COVID-19 by rRT-PCR.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368871


Contacts
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Contact: Bharat Aggarwal 9810077484 Bharat.Aggarwal@maxhealthcare.com

Locations
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India
Max Super Speciality Hospital, A Unit of Devki Devi Foundation Recruiting
New Delhi, India, 110017
Contact: Rajesh Saxena    9818474003    Rajesh.Saxena@maxhealthcare.com   
Sponsors and Collaborators
Max Healthcare Insititute Limited
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Responsible Party: Max Healthcare Insititute Limited
ClinicalTrials.gov Identifier: NCT04368871    
Other Study ID Numbers: Covid-19/RFTC/MHC/2020
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD sharing protocol is undecided at this stage. We may, however, provide data if required

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No