COVIDSCOPeNCT04367064
To Study the Clinical Characteristics and Treatment Outcome of COVID-19 Patients Admitted in Hospitals of Max Healthcare (SCOPe Study)
An observational study of COVID, run by Max Healthcare Insititute Limited at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID
- How many people
- 1,000 participants
- Where
- 1 siteIndia
- Study dates
- 25 Apr 2020to 25 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All the confirmed cases of COVID 19 getting treated at Max Super Speciality Hospital (DDF) as per the standard treatment protocol and policy for COVID 19.
Who may be able to join
- Patients of either sex aged ≥18 years
- Patients who are Covid-19 positive
- All patients with positive Corona virus infection admitted in the hospitals of Max Healthcare will be included in the study.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)
New Delhi, National Capital Territory of Delhi, 110017
Rajesh Saxena, MBA, 9818474003, rajesh.saxena@maxhealthcare.com
Sandeep Budhiraja, MRCP, FACP
About this study
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.
Read the detailed 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.
- Conditions
- COVID
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-4 months
Secondary outcomes (1)
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.
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start25 Apr 2020
- Primary completion25 Nov 2020 (estimated)
- Study completion25 Dec 2020 (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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max Healthcare Insititute Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandeep Budhiraja, MRCP, FACP, Principal investigator, Max Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367064
- Sponsor's protocol ID
- SCOPe/MHC/Covid-19/2020
- Acronym
- SCOPe
- Status last verified
- Jul 2020
- First submitted
- 26 Apr 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing is undecided at this stage. We may, however, provide the data if requested.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Clinical Characteristics and Treatment Outcome of COVID-19 Patients Admitted in Hospitals of Max Healthcare (SCOPe Study)
- ClinicalTrials.gov ID
- NCT04367064
- Acronym / sponsor ID
- SCOPe / SCOPe/MHC/Covid-19/2020
- Conditions
- COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Max Healthcare Insititute LimitedUniversity, hospital or other
- Study start
- 25 Apr 2020 (actual)
- Primary completion
- 25 Nov 2020 (estimated)
- Study completion
- 25 Dec 2020 (estimated)
- First posted
- 29 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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the confirmed cases of COVID 19 getting treated at Max Super Speciality Hospital (DDF) as per the standard treatment protocol and policy for COVID 19.
Key inclusion criteria (3 listed)
- Patients of either sex aged ≥18 years
- Patients who are Covid-19 positive
- All patients with positive Corona virus infection admitted in the hospitals of Max Healthcare will be included in the study.
Key exclusion criteria (1 listed)
- -
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
we will compare the clinical outcome of the COVID 19 patients with their age and gender
Time frame: 3-4 months
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.
1 secondary outcome
we will compare the effect of different treatments given to the COVID 19 patients at Max Hospital
Time frame: 3-4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: Undecided. IPD sharing is undecided at this stage. We may, however, provide the data if requested.
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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.
Sandeep Budhiraja, MRCP, FACP principal investigator
Max Healthcare
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 3 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 14 Jul 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 Sandeep Budhiraja, MRCP, FACP (9810262954, sbudhiraja@maxhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
we will compare the clinical outcome of the COVID 19 patients with their age and gender (time frame: 3-4 months). 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 14 Jul 2020.