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CTRI Number  CTRI/2020/09/027992 [Registered on: 23/09/2020] Trial Registered Prospectively
Last Modified On: 16/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Investigator Initiated Study to Evaluate the Effectiveness and Safety of Thymosin α-1 (Tα1) in Moderate COVID-19 Patients 
Scientific Title of Study   A Prospective, Single-Center,Two-Arm(Standard Control),Randomized Investigator Initiated Clinical Study to Evaluate the Effectiveness and Safety of Thymosin α-1 (Tα1) in Moderate COVID-19 Patients  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IIT_THY_002_20,Version 01 dated 01 July 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Om Shrivastava 
Designation  Unit Head- Infectious Diseases Specialist 
Affiliation  Kasturba Hospital  
Address  Kasturba Hospital for Infectious Diseases, Department of Infectious Disease, Sane Guruji Marg Arya Nagar Chinchpokli Mumbai Maharashtra 400034

Mumbai
MAHARASHTRA
400034
India 
Phone  919869118780  
Fax    
Email  omshrivastav70@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Adarsh Shetty  
Designation  Senior Manager - Regulatory Affairs  
Affiliation  Gufic Biosciences Limited 
Address  Gufic Biosciences Limited, Department of Regulatory Affairs, Subhash Road A Block Vile Parle East Mumbai MAHARASHTRA India

Mumbai
MAHARASHTRA
400057
India 
Phone  912267261000   
Fax    
Email  medicalaffairs@guficbio.com  
 
Details of Contact Person
Public Query  
Name  Dr Adarsh Shetty  
Designation  Senior Manager - Regulatory Affairs  
Affiliation  Gufic Biosciences Limited 
Address  Gufic Biosciences Limited, Department of Regulatory Affairs, Subhash Road A Block Vile Parle East Mumbai MAHARASHTRA India

Mumbai
MAHARASHTRA
400057
India 
Phone  912267261000   
Fax    
Email  medicalaffairs@guficbio.com  
 
Source of Monetary or Material Support  
Kasturba Hospital for Infectious Diseases Sane Guruji Marg, Arya Nagar, Chinchpokli Mumbai, Maharashtra 400034  
 
Primary Sponsor  
Name  Dr Om Shrivastava 
Address  Kasturba Hospital for Infectious Diseases Sane Guruji Marg, Arya Nagar, Chinchpokli Mumbai, Maharashtra 400034  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
iDD Research Solutions Pvt Ltd  4th Floor, Ektha Serene, located at 103/H G- B & 104 HIG-B Survey, No 132, APHB Colony, Gachibowli, Hyderabad, Telangana 500032 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Om Shrivastava  Kasturba Hospital   Department of Infectious Disease, Sane Guruji Marg, Arya Nagar, Chinchpokli Mumbai, Maharashtra 400034
Mumbai
MAHARASHTRA 		 919869118780

omshrivastav70@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Immunocin α 1.6 mg  Two subcutaneous injections of 1.6 mg Tα1 twice daily for seven consecutive days.  
Comparator Agent  SOC alone   2 subcutaneous injections of 1.6 mg Tα1 twice daily along with SOC  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Male/females of ≥ 18 years of age at the time of consent
2.Patient who can and willing to provide written Informed Consent
3 Moderate Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test /any other confirmatory tests
4 Patient with pneumonia with no signs of severe disease
5 If the patient presents any one of the following features:
-Respiratory rate of ≥ 24 breath/min
-SpO2 (oxygen saturation) ≤ 94% on room air
6.Patient/ patient’s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements
 
 
ExclusionCriteria 
Details  Male/females of ≥ 18 years of age at the time of consent
2 The patient who can and willing to provide written Informed Consent
Moderate Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection
confirmed by polymerase chain reaction (PCR) test /any other confirmatory tests
4. Patient with pneumonia with no signs of severe disease
5. If the patient presents any one of the following features:
- Respiratory rate ≥ 24 breath/min to < 30 breath/min
- SpO2 (oxygen saturation) >90% to ≤ 94% on room air
6. Patient/ patient’s LAR understands and is willing to participate in the clinical
study and can comply with clinical trial protocol requirements
The patient who has participated in another trial with an investigational drug within 1
a month prior to this trial.
Patients who, in the judgment of the investigator will be unlikely to comply with
the requirements of this protocol 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Duration of ICU stay [from baseline to End of study (Day 7)]
2.Ventilator duration [from baseline to End of study (Day 7)]
3.Incidences of all-cause hospital mortality [ Time Frame: From date of Drug
administered until the date of hospital discharge or date of death from any cause,
whichever came first, assessed up to 28 days]
4.Duration of hospitalization [ from baseline to hospital discharge] 		 1.Day 1 to Day 7
2.Day 1 to Day 7
3.Day 1 to Day 28
4.Day 1 to Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Total lymphocytes count CD4 and CD8 count from baseline
Change in Ferritin levels IL-6 LDH,CRP D-dimer from baseline
Change in SpO2 level from baseline till the End of study (Day 7)
Evaluation of Clinical progression/deterioration based on 8-point ordinal scale
time frame up to 7 days on Day 1 Screening and End of study (Day 7)
Number of Treatment Emergent Adverse Event TEAE and Treatment Emergent
Serious Adverse Event TESAE 		 1.Baseline to Day 7
2.Baseline to Day 7
3.Baseline to Day 7
4.Screening Day1 to Day 7
5.Day 1 to End of study 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   25/09/2020 
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="3"
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  

This is a Single Centre, Two Arm (Standard control) Randomized  Investigator-Initiated Study.

 

Thymosin-?1 (T?1), a kind of polypeptide hormone produced by thymic epithelial cells, can effectively increase T cell numbers, support T cell differentiation, maturation, and reduce cell apoptosis.T?1 looks a potential treatment that can be dosed in combination with standard of care in patients with COVID 19. Hence, in this present study, we plan to evaluate and compare the effectiveness and safety of T?1 in Combination with Standard of Care (SOC), in moderate COVID 19 patients. If found to be successful, will provide evidence to undertake a large-scale trial to cure COVID 19 infected patients. It will be a breakthrough invention in the medical field. Thus, the research poses potentially great benefits to society.

 

All subject eligible subjects will be getting medications as per the randomization schedule either Treatment arm A or B in 1:1 ratio patients will be administered 2 subcutaneous injections of 1.6 mgThymosin-?1 (T?1)  twice daily along with SOC for 7 days as per the guidelines by the Government of India Ministry of Health & Family Welfare. During the study Demography, physical examination including vital signs (B.P, pulse rate, respiration rate, Oxygen (O2) saturation), chest X-ray will be recorded. All patients will undergo clinical laboratory tests for biomarkers and for safety

 

 
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