CTRI Trial Data

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Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 19:37:05 GMT)

CTRI Number CTRI/2020/05/025431 [Registered on: 29/05/2020] - Trial Registered Prospectively Last Modified On 29/05/2020 Post Graduate Thesis No Type of Trial Observational Type of Study Cross Sectional Study Study Design Other Public Title of Study A study to find our proportion of Covid 19 cases, need for hospital beds and utility of lockdown at Aurangabad Scientific Title of COVID-19 disease load, hospital preparedness and utility of lockdown: Observational study at Study Aurangabad Secondary IDs if Any Secondary ID Identifier 178 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Jagannath Dixit Trial Coordinator (multi-center study) Designation Associate Professor Affiliation Associate Professor, Department of Community Medicine, Government Medical College Address Room No 2, Department of Community Medicine, Government Medical College, Panchakki Road, Aurangabad Room No 2, Department of Community Medicine, Government Medical College, Panchakki Road, Aurangabad Aurangabad MAHARASHTRA 431001 India Phone 9922994777 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Jagannath Dixit Query) Designation Associate Professor Affiliation Department of Community Medicine, Government Medical College Address Room No 2, Department of Community Medicine, Government Medical College, Panchakki Road, Aurangabad Room No 2, Department of Community Medicine, Government Medical College, Panchakki Road, Aurangabad Aurangabad MAHARASHTRA 431001 India Phone 9922994777 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Jagannath Dixit Designation Associate Professor Affiliation Department of Community Medicine, Government Medical College Address Room No 2, Department of Community Medicine, Government Medical College, Panchakki Road, Aurangabad Room No 2,

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Department of Community Medicine, Government Medical College, Panchakki Road, Aurangabad Aurangabad MAHARASHTRA 431001 India Phone 9922994777 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Government Medical College and Hospital, Panchakki Road, Aurangabad Maharashtra- 431001 Primary Sponsor Primary Sponsor Details Name Dr Jagannath Dixit Address Room No 2, Department of Community Medicine, Government Medical College, Panchakki Road, Aurangabad-431001 Type of Sponsor Other [Principal Investigator] Details of Secondary Name Address Sponsor Dr Jyoti Iravane Government Medical College, Aurangabad Dr Kananbala Yelikar Government Medical College, Aurangabad Dr Md Ghodke Government Medical College, Aurangabad Dr Mohan Doibale Government Medical College, Aurangabad Dr Smita Andurkar Government Medical College, Aurangabad Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Jagannath Dixit Government Medical Room No 2, 9922994777 College Department of Community Medicine, [email protected] Government Medical College, Panchakki Road, Aurangabad-431001 Aurangabad MAHARASHTRA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional ethics Approved 22/05/2020 No committee (IEC-GMCA) Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers Covid 19 infection (?) Intervention / Type Name Details Comparator Agent Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 99.00 Year(s) Gender Both Details All adults of age 18 years and above shall be included. They should

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be resident of Aurangabad for at least six months at the time of data collection. Exclusion Criteria Exclusion Criteria Details Migrant population Not giving consent Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Percentage of households with Covid 19 At 4 weeks infection Secondary Outcome Outcome Timepoints Projection of requirement of hospital beds 1 month Target Sample Size Total Sample Size=300 Sample Size from India=300 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A Date of First 08/06/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=3 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details Results shall be published in peer reviewed journal Brief Summary Covid 19 is spreading fast in India. We know little about epidemiology of this disease as of now. It is necessary to know about actual infection rate in the population. This will help to understand the number of hospital beds required and also equipment and manpower. The rate of infection will also throw light about utility of lockdown as a public health measure used to stop community transmission. This study will be done at Municipal Corporation area of Aurangabad. By 30 cluster technique, we shall select 30 clusters randomly. From each cluster 10 households shall be included in the study. Swabs and data from five members of each househlod shall be collected. Data shall be entered by using a google form after taking consent of the participant. SWabs shall be sent VDRL of Government Medical College, Aurangabad. Data shall be analysed and interpreted. Results shall be provided to important stake holders in the district.

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