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CTRI Number  CTRI/2020/08/027061 [Registered on: 10/08/2020] Trial Registered Prospectively
Last Modified On: 04/11/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Trial 
Public Title of Study   Investigator Initiated Study to see the safety and efficacy of adding Thymosin Alpha to existing standard of care in severe COVID patients. 
Scientific Title of Study   A Prospective, Single-Center, Investigator Initiated Clinical Study to Evaluate the Effectiveness and Safety of Thymosin α-1 (Tα1) in severe COVID-19 patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IITTHY00120,Version 01 dated 28 Jun 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul pandit 
Designation  Director - Intensive Care Unit 
Affiliation  Fortis Hospital 
Address  Mulund Goregaon Link Road, Nahur West, Industrial Area, Mulund West,Mumbai
Department of Intensive Care Unit.
Mumbai
MAHARASHTRA
400078
India 
Phone  919820595519  
Fax    
Email  icupandit@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 Subhash Road A Block Vile Parle East Mumbai

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 Subhash Road A Block Vile Parle East Mumbai

Osmanabad
MAHARASHTRA
400057
India 
Phone  912267261000  
Fax    
Email  medicalaffairs@guficbio.com  
 
Source of Monetary or Material Support  
Fortis Hospital Mulund Goregaon Link Rd, Nahur West, Industrial Area, Mulund West, Mumbai, Maharashtra 400078 
 
Primary Sponsor  
Name  Dr Rahul Pandit 
Address  Fortis Hospital Mulund Goregaon Link Rd, Nahur West, Industrial Area, Mulund West, Mumbai, Maharashtra 400078 
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 Rahul pandit  Fortis Hospital   Department of Intensive Care Unit, Mulund Goregaon Link Rd, Nahur West, Industrial Area, Mulund West, Mumbai, Maharashtra 400078
Mumbai
MAHARASHTRA 
919820595519

icupandit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Fortis Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  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 TID per day for at least seven consecutive days.  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Male females of greater 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.Severe Acute Respiratory Syndrome Coronavirus SARS CoV 2 infection confirmed by polymerase chain reaction PCR test any other confirmatory tests
4.If the patient presents any one of the following features
respiratory distress with a respiratory rate greater than 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 FiO2 Fraction of Inspired Oxygen less than or equal to 200 mmHg 1 mmHg 0.133 kPa
Patient presents respiratory failure and requires mechanical ventilation support
5.Patient patients LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements.

 
 
ExclusionCriteria 
Details  1 Patient who has participated in any other clinical trial of an experimental treatment for COVID-19
2 Patient with 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 Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Incidences of all-cause hospital mortality

2.Duration of patients admitted in ICU and use of Ventilator.

3.Duration of hospitalization  
1. Incidences of all-cause hospital mortality

2.Day 1 to Day 7

3.From baseline to hospital discharge 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in Total lymphocytes count, CD4 and CD8 count
2.Change in Ferritin levels, IL-6, LDH,CRP, D-dimer
3.Change in SpO2 level
4.Evaluation of Clinical progression deterioration based on 8-point ordinal scale
5.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="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/08/2020 
Date of Study Completion (India) 01/11/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Brief Summary   This is a Single Centre, Open Lable, Single Arm  Investigator Initiated Study.

Thymosin-α1 (Tα1), 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.Tα1 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 Tα1 in combination with Standard of Care (SOC), in severe COVID 19 patients. If found to be successful, will provide an evidence to undertake a large-scale trials to cure COVID 19 infected patients. It will be a breakthrough invention in medical field. Thus, the research poses potentially great benefits to the society.

All subject eligible subjects will be getting Thymosin-α1 (Tα1) as an additional durg to the Existing Standard of Care as per the guidelines of 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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