| CTRI Number |
CTRI/2021/06/034064 [Registered on: 08/06/2021] Trial Registered Prospectively |
| Last Modified On: |
15/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Trial to assess benefit of adding Chlorpromazine to the current Standard of Care in treating patients who are moderately infected with COVID-19. Â
|
|
Scientific Title of Study
|
A Phase II B III, Multi Centre Open label Randomized Controlled trial to assess Clinical Benefits of Chlorpromazine and Standard of Care Versus Standard of Care alone in the management of moderate SARS COV 2 infection |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CSC-CT-013 Version 2 Dated 09 Feb 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prakash Prahlad Khetan |
| Designation |
MD(Medicine) |
| Affiliation |
Shravan Hospital and Kidney Institute |
| Address |
Shravan Hospital and Kidney Institute, Department Of Medicine, First floor, Room No. 101 Plot No 239, Nandanvan Main Road, Nandanvan, Nagpur, Maharashtra 440009
Shravan Hospital and Kidney Institute, Department Of Medicine, First floor, Room No. 101 Plot No 239, Nandanvan Main Road, Nandanvan, Nagpur, Maharashtra 440009
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9823071748 |
| Fax |
|
| Email |
khetanpp84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AVS Suresh |
| Designation |
Chief Medical Officer |
| Affiliation |
ClinSync Clinical Research Pvt. Ltd. |
| Address |
ClinSync Clinical Research Pvt. Ltd. Fourth floor Room No. 401 JSR Mall Plot no.7to18 Survery no.225 Opp Mythri Nagar Madeenaguda Telangana
ClinSync Clinical Research Pvt. Ltd. Fourth floor Room No. 401 JSR Mall Plot no.7to18 Survery no.225 Opp Mythri Nagar Madeenaguda Telangana
Hyderabad
TELANGANA
500049
India |
| Phone |
9246243034 |
| Fax |
|
| Email |
attili@clinsynccro.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Shriram Vedapuri |
| Designation |
Project Manager |
| Affiliation |
ClinSync Clinical Research Pvt. Ltd. |
| Address |
ClinSync Clinical Research Pvt. Ltd. Clinical Trial Management Department, Third Floor, Room No. 301 JSR Mall,Plot no.7to18,Survery no.225,Opp, Mythri Nagar, Madeenaguda, Telangana
ClinSync Clinical Research Pvt. Ltd. Clinical Trial Management Department, Third Floor, Room No. 301 JSR Mall,Plot no.7to18,Survery no.225,Opp, Mythri Nagar, Madeenaguda, Telangana
Hyderabad
TELANGANA
500049
India |
| Phone |
9223393438 |
| Fax |
|
| Email |
shriram.v@clinsyccro.com |
|
|
Source of Monetary or Material Support
|
| CSIR IICT
Council of Scientific and Industrial Research Anusandhan Bhavan
2 Rafi Marg
New Delhi 110001
acting through Indian Institute of Chemical Technology Hyderabad
Izatech Labs Private Limited at 666 Road Number 34 Jubilee Hills Hyderabad 500033 India |
|
|
Primary Sponsor
|
| Name |
CSIRIICT |
| Address |
Council of Scientific and Industrial Research- Indian Institute
of Chemical Technology [CSIR IICT]
Uppal Road, Tarnaka, Hyderabad, Telangana 500007,India. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Izatech Labs |
666 Road Number 34 Jubilee Hills Hyderabad 500033 India |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karthik |
Government General and Chest Hospital |
Dept of Pulmonary Medicine, Irramnuma,Erragadda,Hyderabad.T.S.India
Hyderabad
TELANGANA |
9849424240
vkarthikrao@gmail.com |
| Dr Kethavath Sunil Naik |
Government Medical College and Government General Hospital |
Government Medical College and Government General Hospital( OLD RIMSGGH), Srikakulam Andhra Pradesh 562001
Srikakulam
ANDHRA PRADESH |
9440828299
drsunilnaikggh@gmail.com |
| Dr Kangula Sudheer |
Great Eastern Medical College and Hospital |
Ragolu,Srikakulam, A.P.India -532484
Srikakulam
ANDHRA PRADESH |
9666123122
drksudheerresearch@gmail.com |
| Dr Manish Kumar Jain |
Maharaja Agrasen Super speciality Hospital |
Central Spine, Agrasen Aspatal Marg, Sector -7
Vidyadhar Nagar, Jaipur-302039, Rajasthan, India
Jaipur
RAJASTHAN |
9414414834
doctormanishjain2@gmail.com |
| Dr Praveen |
Mallareddy Medical College for Women |
Suraram cross roads,Jeedimetla, Hyderabad.T.S.India
Hyderabad
TELANGANA |
6364526826
pravin.dtcd@gmail.com |
| Dr Prakash Prahlad Khetan |
Shravan Hospital and Kidney Institute, |
Shravan Hospital and Kidney Institute Dept Of Medicine Room No. 101 Plot No 239 Nandanvan Main Road Nandanvan Nagpur Maharashtra 440009
Nagpur
MAHARASHTRA |
9823071748
khetanpp84@gmail.com |
| Dr Vinayak Maruti Sawardekar |
St George Hospital |
Grant Government Medical College & Sir JJ Group of Hospitals, Byculla Mumbai,
Mumbai
MAHARASHTRA |
9820747703
vinayaks1812@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommitteeDepartmentofPharmacologyGrantgovernmentMedicalCollegeand Sir JJ group of HospitalsBycullaMumbai400008MaharashtraIndia |
Approved |
| Gillurkar Hospital Ethics Commitee |
Approved |
| Institutional Ethics Committee, Govt Medical College and Govt General Hospital, OLD RIMS, Srikakulam Andhra Pradesh 562001 |
Approved |
| Institutional Ethics Committee, Great Eastern Medical School & Hospital |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Hospital |
Approved |
| Malla Reddy Medical For Women Institutional Ethics Committee |
Approved |
| Osmania Medical College, Institutional Ethics Committee |
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
|
| Type |
Name |
Details |
| Intervention |
Chlorpromazine tablet oral |
Chlorpromazine 25mg BD Oral for 10 days,50mg BD Oral for 10 days,100mg BD Oral for 10 days |
| Comparator Agent |
Not applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Documented COVID-19 infection as observed by positive RT-PCR for SARS-CoV-2 on the day of screening.
Adult having moderate form of infection defined as presence of clinical features of dyspnea, and or hypoxia, fever, cough including spO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute
|
|
| ExclusionCriteria |
| Details |
Patients suffering from severe Covid-19 disease as per the physician’s discretion.
History of Chronic illness will be obtained and those with a history of active, ongoing disease will be excluded. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time To Response TTR measured as the number of days since randomization in which there is reduction of at least one severity level of the disease measured using a World Health Organization 8 Point Ordinal Scale for Clinical Improvement WHO OSCI. |
Baseline and 3 weeks (21 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A decrease in the swab viral load of SARSCOV2
Reduction in the need for intensive care in the treatment arm versus SOC A decrease in inflammatory markers will be measured at screening and End of Treatment |
Baseline and 3 weeks (21 days) 8.5 weeks (60 days) if SAE occurs |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/06/2021 |
| 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="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Design: Open-label, Multicentre, Randomized, Parallel-Group, Two arm study
To compare the Time to Response to treatment with Standard of Care Chlorpromazine CPZ Versus SOC alone TTR is defined as the reduction of at least one level of severity relative to the baseline as per the World Health Organization [WHO] 8 - point ordinal scale for clinical improvement. The median time to produce the first response measured as a reduction in severity will be compared between the treatment arm SOC PLUS CPZ and the comparator
The primary measure of the efficacy of the drug chlorpromazine will be the reduction in the number of days required to produce the first response. This response is defined as the reduction in the severity of the disease
To demonstrate that greater clinical improvement is seen on treatment with SOC PLUS Chlorpromazine versus SOC alone. Clinical improvement will be monitored post-dosing and will be assessed based on the following parameters 1. A decrease in the swab viral load of SARS COV 2 2. A decrease in inflammatory markers will be measured at screening and End of Treatment EOT. The inflammatory markers which will be evaluated are: C Reactive Protein , lymphocytes, Interleukin-6 , Lactate dehydrogenase , inflammatory cytokines, NT-ProBNP, hScTn, Platelet count, Sr. Ferritin and coagulation factors like platelets, D-Dimer
The study population will comprise male & non-pregnant, non-lactating female patients between 18-65 years who are evaluated as moderate cases of COVID19. Moderate cases will be defined as per the ICMR guidelines and treating Investigator assessment. The selection of the participants will be strict as per the eligibility criteria described in the protocol. The recruitment will be voluntary and without any coercion. Participants will be fairly selected and no particular group will be coerced to participate. All participants will be enrolled only after obtaining valid written informed consent. In case a vulnerable population is to be enrolled, the enrolment will be properly justified so that at all times safety, wellbeing, and rights of the
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