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

Study Overview

• Status: Unknown
• Conditions: 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).

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110017
    • Recruiting
    • Max Super Speciality Hospital, A Unit of Devki Devi Foundation
    • Contact: Rajesh Saxena; Phone Number: 9818474003; Email: rajesh.saxena@maxhealthcare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4-8 weeks

Collaborators and Investigators

• Sponsor: Max Healthcare Insititute Limited

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): May 30, 2021

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Covid-19/RFTC/MHC/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: IPD sharing protocol is undecided at this stage. We may, however, provide data if required

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No