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CTRI Number  CTRI/2020/10/028277 [Registered on: 07/10/2020] Trial Registered Prospectively
Last Modified On: 18/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to assess the safety and effectiveness of Thymosin α-1 (Tα1) used for the treatment of Moderate to severe COVID 19 Patients.  
Scientific Title of Study   A Double Blind, Multi-Center, Two- Arm, Randomized, Placebo Controlled, Phase III Clinical Study to Evaluate the Effectiveness and Safety of Thymosin α-1 (Tα1) as an Add on Treatment to Existing Standard of Care Treatment in Moderate to Severe COVID-19 Patients  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GB_THY_001_20 Version 02 dated 24 Aug 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Adarsh Shetty 
Designation  Senior Manager - Medical Affairs 
Affiliation  Gufic Biosciences Limited 
Address  Gufic Biosciences Limited Subhash Road A Block Vile East Mumbai Maharashtra India

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

Mumbai
MAHARASHTRA
400057
India 
Phone  912267261000  
Fax    
Email  medicalaffairs@guficbio.com  
 
Details of Contact Person
Public Query  
Name  Mr Vairamuthu Ammaiyappan 
Designation  Associate Director 
Affiliation  iDD Research Solutions Pvt Ltd 
Address  4th Floor Ektha Serene located at 103 H G B and 104 HIG B Survey No 132 APHB Colony Gachibowli

Hyderabad
TELANGANA
500032
India 
Phone  919606829331  
Fax    
Email  vairamuthu.ammaiyappan@iddresearch.com  
 
Source of Monetary or Material Support  
Gufic Biosciences Limited,Subhash Road-A Block,Vile Parle East Mumbai,Maharashtra-400057 
 
Primary Sponsor  
Name  Gufic Biosciences 
Address  Gufic Biosciences Limited Subhash Road A block vile parle East Mumbai Maharashtra India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dev Nath Jha  Batra Hospital and Medical Research Centre  Room no 15,Ground floor, Department of Medicine Batra Hospital and Medical Research Center 1 Tughlakabad Institutional Area M B Road New Delhi 110062
New Delhi
DELHI 		 911129957661

drdnjha@yahoo.co.in 
Dr Arti Shah  Dhiraj Hospital  Department of Respiratory Medicine Sumandeep Vidyapeeth an Institution Deemed to be University & Dhiraj Hospital At and Po Piparia Ta.Waghodia Vadodara 391760 Gujarat
Vadodara
GUJARAT 		 919925047880

artidhawal76@gmail.com 
DrPrachee Milind Sathe  Grant Medical Foundation Ruby Hall Clinic  ICU,1st floor,Ruby Hall, 40, Sasoon Rd, Sangamvadi, Pune, 411001, Maharashtra, India
Pune
MAHARASHTRA 		 020-66455495

prachi.sathe@gmail.com 
Dr S K Sonkar  King Georges Medical University  Department of Medicine King Georges Medical University Shahmina Road Chowk Lucknow 226003 Uttar Pradesh India
Lucknow
UTTAR PRADESH 		 919307288648

satyendra.sonkar@gmail.com 
Dr Nirhali Sonali Chandrakant  Lifepoint Multispecialty Hospital  Depatment of Medicine,OPD No 3,1st floor ,145/1, Mumbai Bangalore Highway,Near Hotel Sayaji,Wakad, Pune-411057, Maharashtra, India.
Pune
MAHARASHTRA 		 020-66434366

sonalinirhali26@gmail.com 
Dr Abhijeet Mantri  Mantri Hospital  98, Erandawane Gauthan, Near Kamal Prabha Book Store, Near Mhatre Bridge, Pune, Maharashtra 411004
Pune
MAHARASHTRA 		 9822096460

mantri_a@rediffmail.com 
Dr Manjunath  PGIMS, Rohtak  Medical Rd, Rohtak, Haryana 124001
Rohtak
HARYANA 		 8050452310

bgmanzu@gmail.com 
Dr Rahul Ashok Darnule  St Georges Hospital  Department of Medicine, Nursing home ground floor, St Georges Hospital Grant Government Medical College and Sir JJ Group of Hospitals PD Mello Road CST Mumbai 400001 Maharashtra India
Mumbai
MAHARASHTRA 		 917387506090

rahuldarnule@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Institutional Ethics Committee,SV  Approved 
Independent Ethics Committee Dhanashree Hospital  Approved 
Institutional Ethics Committe,PGIMS,UHS,Rohtak  Approved 
Institutional Ethics Committee King George’s Medical University  Approved 
INSTITUTIONAL Ethics COMMITTEE, GGMC,  Approved 
Institutional Ethics Committee, Poona Medical Research Foundation  Approved 
LPR Ethics Committee  Approved 
Scientific Research and Ethical Review Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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 
Comparator Agent  Placebo Injection along with SOC  Each vial contains : Excipients...... q.s (Lyophilized) Sterile water for Injections IP 1Ml Ampoule Manufactured by: Gufic Biosciences Ltd., India Dose: Placebo x 2 injections Frequency: Twice daily(Moderate)and Thrice daily (Severe) Route of administration: Subcutaneous Total Duration 7 days  
Intervention  Thymosin α-1-1.6 mg Injection along with SOC  Each vial contains : Thymosin Alpha 1-1.6mg Excipients...... q.s (Lyophilized) Sterile water for Injections IP 1ml Ampoule Manufactured by: Gufic Biosciences Ltd., India Dose:Thymosin α-1-1.6 mg x 2 injections Frequency: Twice daily(Moderate)and Thrice daily (Severe) Route of administration: Subcutaneous Total Duration 7 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female of more than or equal to 18 years of age at the time of consent
2. Patient who can and willing to provide written Informed Consent
3. Patient or patient’s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements

Inclusion criteria for moderate COVID-19 patients

4. Moderate Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test or any other confirmatory tests
5. Patient with pneumonia with no signs of severe disease
6. If the patient presents any one of the following features:
- Respiratory rate of more than or equal to  24 breath per min
- SpO2 (oxygen saturation) more than 90 percent to less than or equal to 94 percentage on room air

Inclusion criteria for severe COVID-19 patients

7. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test or any other confirmatory tests
8. If the patient presents any one of the following features:
- respiratory distress with a respiratory rate of more than or equal to 30 breath per min
- SpO2 (oxygen saturation) less than or equal to 90 percentage on room air
- PaO2 (arterial blood oxygen partial pressure) or FiO2 (Fraction of Inspired Oxygen) less than or equal to 200 mmHg (1 mmHg equal to 0.133 kPa)
- Patient presents respiratory failure and requires mechanical ventilation support

 
 
ExclusionCriteria 
Details  1. Patient who has participated in any other clinical trial of an experimental treatment for COVID-19
2. Patients with the presence of any pre-existing illness that, in the opinion of the investigator, would place the patient at an unreasonably increased risk through participation in this study.
3. Patient who has participated in another trial with an investigational drug within 1 month prior to this trial.
4. Female patient who is breast-feeding, pregnant, or intends to become pregnant during the study
5. Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Incidences of all-cause hospital mortality [Time Frame: From the 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]
2.Evaluation of Clinical progression/deterioration based on an 8-point ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D) [time frame up to 7 days] on Day 1, Screening and End of treatment (Day 7)
 		 1.Day 1 to Day 28
2.Day 1 to Day 7
3.From baseline to hospital
discharge 
 
Secondary Outcome  
Outcome  TimePoints 
1.Duration of ICU stay
2. Ventilator duration
Duration of hospitalization
3.Change in Total lymphocytes count, CD4, and CD8 count
4.Change in Ferritin levels, IL-6, LDH, CRP, D-dimer
5.Change in SpO2 level
6.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 Day 1 to Day 7
5. Day 1 to End of Study 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   12/10/2020 
Date of Study Completion (India) 14/10/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 14/10/2021 
Estimated Duration of Trial   Years="0"
Months="0"
Days="28" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 Double-Blind, Multi-Center, Two- Arm, Randomized, Placebo-Controlled, Phase III Clinical Study

Thymosin- alpha1(Talpha1), 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) and SOC alone, in moderate to severe 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 Active arm or Placebo Arm in 2:1 ratio patients with Moderate symptoms of COVID-19 will be administered 2 subcutaneous injections of Active Treatment (Containing 1.6mg Tα1) or Placebo along with SOC in the morning and 2 subcutaneous injections of Active Treatment (Containing 1.6mg Tα1) or Placebo in the evening along with SOC as per the randomization schedule, from Day 1 to Day 7 and Patients with Severe symptoms of COVID-19 will be administered 2 Subcutaneous injections of Active Treatment (Containing 1.6mg Tα1) or Placebo  thrice daily 
( each) in the morning, afternoon, and evening along with SOC as per the randomization schedule, from Day 1 to Day 7.

Standard of Care (SOC) will be given in both arms as per the revised guidelines of the Government of India Ministry of Health & Family Welfare. During the study Demography, Physical examination including vital signs (BP 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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