| CTRI Number |
CTRI/2021/06/034065 [Registered on: 08/06/2021] Trial Registered Prospectively |
| Last Modified On: |
08/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Cardiovascular disease manifestations in COVID-19 patients |
|
Scientific Title of Study
|
Cardiovascular disease manifestations with special emphasis on myocarditis-in moderate to severe COVID-19 patients undergoing treatment in the ccu of a tertiary care hospital in West Bengal India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati Datta |
| Designation |
Residential Medical Officer cum Clinical Tutor |
| Affiliation |
Medical College, Kolkata |
| Address |
Department - Anaesthesiology
Division - Green Building
Room - 2nd floor, Tutor room no. 1
88 College Street
Kolkata - 700073
West Bengal, India
Kolkata
WEST BENGAL
700002
India |
| Phone |
9836979351 |
| Fax |
|
| Email |
drsiahiri11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Datta |
| Designation |
Residential Medical Officer cum Clinical Tutor |
| Affiliation |
Medical College, Kolkata |
| Address |
Department - Anaesthesiology
Division - Green Building
Room - 2nd floor, Tutor room no. 1
88 College Street
Kolkata - 700073
West Bengal, India
Kolkata
WEST BENGAL
700002
India |
| Phone |
9836979351 |
| Fax |
|
| Email |
drsiahiri11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Datta |
| Designation |
Residential Medical Officer cum Clinical Tutor |
| Affiliation |
Medical College, Kolkata |
| Address |
Department - Anaesthesiology
Division - Green Building
Room - 2nd floor, Tutor room no. 1
88 College Street
Kolkata - 700073
West Bengal, India
Kolkata
WEST BENGAL
700002
India |
| Phone |
9836979351 |
| Fax |
|
| Email |
drsiahiri11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Concered authority, Medical College, Kolkata |
|
|
Primary Sponsor
|
| Name |
Dr Swati Datta |
| Address |
Om Tower Flat - 5 A
36 C B. T. Road
Kolkata - 700002 |
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Asim Kumar Kundu |
4/1 Raj Kumar Chatterjee Road
Kolkata - 700037 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SWATI DATTA |
MEDICAL COLLEGE, KOLKATA |
Department - Anaesthesiology
Division - Green Building
Room - 2nd floor, Tutor room no. 1
88 College Street
Kolkata - 700073
West Bengal India
Kolkata
WEST BENGAL |
9836979351
drslahiri11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MEDICAL COLLEGE, KOLKATA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B99-B99||Other infectious diseases, (2) ICD-10 Condition: B338||Other specified viral diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Case
1. Age more than 18 years
2. Laboratory confirmed COVID-19 patients
3. SpO2 less than 94%
4. Patients on different modalities of oxygen therapy
5. Patients with radiologically confirmed pneumonia
6. ARDS or Acute Respiratory Failure
Control
1. Age more than 18 years
2. COVID-19 RTPCR negative
3. SpO2 less than 94%
4. Patients on different modalities of oxygen therapy
5. Patients with radiologically confirmed pneumonia
6. ARDS or Acute Respiratory Failure
Control |
|
| ExclusionCriteria |
| Details |
1. Moribund patient with septicemia with or without multiorgan dysfunction
2. Patient unwilling to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Need for mechanical ventilation
2. Length of CCU stay
3. Length of hospitalization
4. Incidence of arrhythmia, cardiac arrest during CCU stay
5. Final outcome-discharge or death |
Within 28 days from CCU admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All cause mortality |
Within 28 days from CCU admission |
|
|
Target Sample Size
|
Total Sample Size="382"
Sample Size from India="382"
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)
|
09/06/2021 |
| 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="6"
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
|
Hospitalized patients admitted with fever, cough, sore throat and/or dyspnoea who will be tested positive for SARS-COV-2 will be included in our study and will be matched based on their age and gender with patients admitted with similar symptoms who will be tested negative for SARS-COV-2. The electronic medical charts of the study subjects will be reviewed and relevant demographic, clinical, laboratory and imaging findings will be de-identified and recorded. Demographic characteristics including age at the time of diagnosis, gender, race and BMI will be collected. Past medical history including CAD, heart failure with reduced or preserved ejection fraction, AF, hypertension, dyslipidemia, DM, smoking status as well as home medication will be abstructed. The name and daily dose of ACE inhibitors or ARB will be recorded. Laboratory values including cardiac enzymes, electrolytes, Haemoglobin and creatinine will be collected. Available EKG and TTEs will be individually reviewed by an independent cardiovascular disease fellow or faculty member. Finally clinical outcomes including need for mechanical ventilation, length of intensive care unit stay, length of hospitalization, arrhythmias, cardiac arrest and in hospital mortality will be abstructed from the electronic charts. |