To Study the Clinical Characteristics and Treatment Outcome of COVID-19 Patients Admitted in Hospitals of Max Healthcare (SCOPe Study)

COVID Clinical Trial

— SCOPe  

Official title:

To Study the Clinical Characteristics and Treatment Outcome of COVID-19 Patients Admitted in Hospitals of Max Healthcare (SCOPe Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04367064
• Other study ID #: SCOPe/MHC/Covid-19/2020
• Status: Recruiting
• Start date: April 25, 2020
• Est. completion date: December 25, 2020

Study information

• Verified date: July 2020
• Source: Max Healthcare Insititute Limited
• Contact: Sandeep Budhiraja, MRCP, FACP
• Phone: 9810262954
• Email: sbudhiraja[@]maxhealthcare.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study for Corona virus disease by the Max Healthcare.Corona virus 2019 disease (COVID-19) is a respiratory tract infectious disease caused by a newly emergent corona virus. This virus is linked to the same family of viruses as Severe Acute Respiratory Syndrome (SARS) and some types of common cold.

Description:

In view of increasing cases in India and the possibility of the exponential rise of cases, study has been designed to observe the patient profile and outcomes for hospitalized positive Covid-19 patients that may help to understand the effectiveness of different treatment strategies. This is a retrospective and prospective, observational study based on collection of data related to COVID-19 admitted patients treated in the hospitals of Max Healthcare as per the standard treatment protocol and policy for COVID 19 at Max Healthcare.

Covid19 patients shall be approached at the time of admission for participation in this study. If the patient consents, the participating investigator or designated study personnel will collect the baseline demographic details of the patient, along with medical history; current disease status; current and previous treatment details; and the results of all the laboratory tests performed, as per the standard clinical practices. Daily follow up will be done on a structured case record form (CRF) till the discharge or death.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 25, 2020
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients of either sex aged =18 years

2. Patients who are Covid-19 positive

3. All patients with positive Corona virus infection admitted in the hospitals of Max Healthcare will be included in the study.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• COVID

Locations

Country	Name	City	State
India	Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)	New Delhi	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	we will compare the clinical outcome of the COVID 19 patients with their age and gender	Collection of the baseline demographic details of the patient, along with medical history; current disease status; current and previous treatment details; and the results of all the laboratory tests performed, as per the standard clinical practices. All the data will be entered into Excel sheet, row wise for each patient. For studying the demographic profile, the age will be divided into standard 10-year intervals and percentages will be obtained for each sex and combined for males and females. This will be in addition to the mean and SD of age.	3-4 months
Secondary	we will compare the effect of different treatments given to the COVID 19 patients at Max Hospital	Daily follow up will be done on a structured case record form (CRF) till the discharge or death of the subject. Treatment-Related Adverse Events as Assessed by CTCAE v4.0 will be captured in CRF. Clinical profile and outcome will be analyzed separately for each treatment regimen after suitable grouping of the regimens. Statistical significance of the association of outcomes with the clinical profile and treatment regimens will be checked with chi-square test or Fisher exact test in case the numbers are small. Effectiveness of each regimen will also be checked for significance of difference with chi-square test. A P-value <0.05 will be considered statistically significant but the final conclusion will be based on corroborative evidence and factors such as clinical profile. SPSS 20 will be used for all the calculations.	3-4 months