| CTRI Number |
CTRI/2021/01/030341 [Registered on: 08/01/2021] Trial Registered Prospectively |
| Last Modified On: |
07/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The outcome of Remdesivir and Tocilizumab in COVID 19. |
|
Scientific Title of Study
|
To study the outcome of COVID 19 positive patients who have received Remdesivir or Tocilizumab or their combination during their treatment in a tertiary care hospital. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishal A Gupta |
| Designation |
Associate professor and MICU Incharge |
| Affiliation |
Seth GSMC and KEM Hospital, Mumbai |
| Address |
Department of General Medicine
Seth G S Medical college and KEM hospital, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
|
| Fax |
|
| Email |
drvagupta@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vishal A Gupta |
| Designation |
Associate professor and MICU Incharge |
| Affiliation |
Seth GSMC and KEM Hospital, Mumbai |
| Address |
Department of General Medicine
Seth G S Medical college and KEM hospital, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
|
| Fax |
|
| Email |
drvagupta@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sushrut Ingawale |
| Designation |
Resident |
| Affiliation |
Seth GSMC and KEM Hospital, Mumbai |
| Address |
Department of General Medicine
Seth G S Medical college and KEM hospital, Mumbai 1177 Krishna Clinic, Phulewadi
Kolhapur, Maharashtra Mumbai MAHARASHTRA 400012 India |
| Phone |
9152730657 |
| Fax |
|
| Email |
sushrutingawale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth G S Medical College and KEM Hospital, Mumbai |
|
|
Primary Sponsor
|
| Name |
Seth G S Medical College and KEM Hospital Mumbai |
| Address |
Seth G S Medical College and KEM Hospital Mumbai, Acharya Donde Marg, Parel (East), Mumbai 400012 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishal A Gupta |
Seth G S Medical College and KEM Hospital, Mumbai |
Department of Medicine, 2nd floor, Old building, near Gate no 2, Seth G S Medical College and KEM Hospital Mumbai, Acharya Donde Marg, Parel (East), Mumbai 400012 Mumbai MAHARASHTRA |
9869136601
drvagupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee 3, Seth G. S. Medical College and KEM Hospital, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Laboratory confirmed COVID 19 adults (Age > 18 years) admitted in KEM Hospital.
2.Patients in ICMR group 2B and onwards.
3.Received any of the following drugs alone or in combination: Remdesivir, Tocilizumab. |
|
| ExclusionCriteria |
| Details |
1. Suspected COVID 19 patients.
2. Positive patients in category 1A to 2A
3. Pregnant/Lactating patients.
4. Mortality within 24 hours of admission. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To assess the outcome of COVID 19 positive patients who have received Remdesivir or Tocilizumab or their combination.
2)To observe the clinical factors affecting the outcome.
|
1)1 month.
2)1 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the duration of hospitalization, duration of oxygen therapy and duration required to bring about the change in the score of Ordinal scale for Clinical Improvement given by World Health Organization (WHO), until the final outcome.
To observe for any adverse events, adverse drug reactions or any complications related to the standard treatment. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="500" Sample Size from India="500"
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 Enrollment (India)
|
17/01/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="1" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Novel Coronavirus (n COVID-19) infection is a pandemic that has affected the world and India continues to be one of the worst hit nations with more than 2 million cases till date. The course of the disease and outcome varies as per the existing co-morbidities and age of the patient. Various drugs have been proposed and used over time including Hydroxychloroquine, Lopinavir-Ritonavir, Convalescent plasma, Favipiravir/Remdesivir, Tocilizumab and so on. There are multiple ongoing studies around the world to come up with the best possible treatment. The data from Indian population on the outcome of treatment using these drugs is relatively scarce. Our study is to analyze the outcome of patients who have received these drugs at our institute. This will not only add to the literature but will also help us guide any future amendments in our institutional management protocols, if needed. The study will begin only after approval from the Institutional Ethics Committee. It is a Single-centered, retrospective, observational study. It is secondary analysis of data, hence no direct contact with patient. Therefore waiver of consent is granted. Patients who are Laboratory confirmed COVID 19 adults (Age > 18 years) admitted in KEM Hospital of ICMR group 2B and onwards and received any of the following three drugs alone or in combination: Remdesivir, Tocilizumab will be included. Suspected COVID 19 patients, Positive patients in category 1A to 2A, Pregnant/Lactating patients and Mortality within 24 hours of admission will be excluded. Since Covid 19 is a novel disease with a limited data, sample size cannot be predicted, hence all patients satisfying the inclusion criteria will be included. Patients admitted between 1st April, 2020 and 30th September, 2020 and had an outcome will be included by complete enumeration.The sample size is estimated to be around 500 patients. Data on patient basic details, chronic medical histories, symptoms, vital signs at admission, laboratory values on admission, timing between admission and intubation, timing between admission and mortality/discharge, duration of ventilation, mode of ventilation and other treatment details whatever available, will be studied retrospectively. Outcome measures include: Mortality or Discharge. Duration of Hospitalization, Duration of Oxygen therapy and Duration to bring a change in the score of ordinal scale of clinical improvement given by WHO. The results will be analyzed in SPSS software. Data will be looked to check for Normal distribution or not and accordingly, necessary tests will be applied. Demographic data (eg- Age, Sex, etc) will be analyzed using descriptive statistics. Categorical data (eg- Outcome: Discharge/Death) will be analyzed using non-parametric tests. Continuous data (eg- duration/time) will be analyzed using parametric tests. The data will be analyzed on a personalized computer which is password protected and also an antivirus. Only the principal investigator and Co-investigator will have access to the data. Our study will not only add to the literature but will also help us guide any future amendments in our institutional management protocols, if needed. Results & analyses will be shared at the end of the study, |