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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04368871
Other study ID # Covid-19/RFTC/MHC/2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 28, 2020
Est. completion date May 30, 2021

Study information

Verified date April 2020
Source Max Healthcare Insititute Limited
Contact Bharat Aggarwal
Phone 9810077484
Email Bharat.Aggarwal@maxhealthcare.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date May 30, 2021
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
India Max Super Speciality Hospital, A Unit of Devki Devi Foundation New Delhi

Sponsors (1)

Lead Sponsor Collaborator
Max Healthcare Insititute Limited

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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