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CTRI Number  CTRI/2021/12/038850 [Registered on: 22/12/2021] Trial Registered Prospectively
Last Modified On: 21/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A clinical trial to know about the Efficacy and Safety of GT0918 in Outpatients with Mild to Moderate COVID-19 Illness. 
Scientific Title of Study   A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Outpatients with Mild to Moderate COVID-19 Illness. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
GT0918-US-3001 Version No. 2.0 dated 06/Jul/2021  Protocol Number 
NCT05009732  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research LLP 
Address  Second Floor, Skoda House, Opposite L J Campus S G Highway, Sarkhej, Ahmedabad, GUJARAT – 382210, India

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research LLP 
Address  Second Floor, Skoda House, Opposite L J Campus S G Highway, Sarkhej, Ahmedabad, GUJARAT – 382210, India


GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research LLP 
Address  Second Floor, Skoda House, Opposite L J Campus S G Highway, Sarkhej, Ahmedabad, GUJARAT – 382210, India


GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Source of Monetary or Material Support  
Suzhou Kintor Pharmaceuticals, Inc., 20 Songbei Road, Suzhou Industrial Park, China (Jiangsu) Pilot Free Trade Zone, Suzhou 215024, P.R. China  
 
Primary Sponsor  
Name  Suzhou Kintor Pharmaceuticals Inc 
Address  20 Songbei Road, Suzhou Industrial Park, China (Jiangsu) Pilot Free Trade Zone, Suzhou 215024, P.R. China 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NA  NIL 
 
Countries of Recruitment     United States of America
Brazil
India
Mexico
South Africa  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr ME Mohan  BGS Global Institute of Medical Sciences and Hospital  #67, BGS Health & Education City, 2nd floor, medical college building, Uttarahalli Road Kengeri, Bangalore South – 560060, Karnataka, India
Bangalore
KARNATAKA 		 9900126444

drmohanbgsresearch@gmail.com 
Dr Vivek G  Rajarajeswari Medical College and Hospital  Ground floor, OPD Building, 202, Mysore Road, Kengeri Satellite Town, Kambipura, Bangalore-560 074 Karnataka, India
Bangalore
KARNATAKA 		 9739701000

vivek.g27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
BGS Global Institute of Medical Sciences  Approved 
Institutional Ethics Committee Rajarajeswari Medical College and Hospital  Submittted/Under Review 
 
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  Dosage: 200mg, Frequency: Once daily, Route of Administration: Oral, Duration of Therapy: 14 Days  
Intervention  Proxalutamide  Dosage: 200 mg, Frequency: Once daily, Route of Administration: Oral, Duration of Therapy: 14 Days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects will be considered eligible for the study based on the following criteria:

1. The subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
2. Understand and agree to comply with planned study procedures.
3. Male and non-pregnant female subjects with age greater than or equal to 18 years of age at the time of randomization
4. Are currently not hospitalized.
5. Have one or more COVID-19-related symptoms within 5 days of onset of symptoms onset (FDA COVID-19-Related symptom guidance, See Appendix 2, available at: https://www.fda.gov/media/142143/download)
6. Must have first positive SARS-CoV-2 viral infection determination (has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen) less than or equal to 3 days prior to start of the first dose.
7. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception, as shown below, throughout the study and for 3 months after stopping GT0918 treatment. Highly effective contraception methods include:
Total Abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception, or
Use of one of the following combinations (a+b or a+c or b+c):
a. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate less than 1%), for example hormone vaginal ring or transdermal hormone contraception.
b. Placement of an intrauterine device or intrauterine system;
c. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical or vault caps) with spermicidal foam or gel or film or cream or vaginal suppository;
Female sterilization (have had prior surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment;
Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject;
In case of use of oral contraception women should have been stable for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment, is she considered not of childbearing potential;
8. Regardless of their fertility status, male subjects must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms as well as one additional highly effective method of contraception (less than 1 percent failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 90 days after the last dose.
9. Agree to the collection of nasopharyngeal swabs and venous blood.
 
 
ExclusionCriteria 
Details  Subjects will be excluded from the study based on the following criteria:
Have SpO2 less than or equal to 93% on room air at sea level or PaO2 or FiO2 less than300, respiratory rate greater than or equal to30 per minute, heart rate greater than or equal to125 per minute (FDA resource page, COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry (fda.gov)).
Estimated glomerular filtration rate (eGFR) less than30 ml per min
Serum total bilirubin greater than 1.5 x ULN (upper limit of normal) and AST and ALT greater than3 x ULN
Subjects with significant cardiovascular disease as following:
i. heart failure NYHA class greater than or equal to3
ii. left ventricular ejection fraction less than 50 percent
iii. those with a history of cardiac arrhythmias, including long QT syndrome.
Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to COVID-19 or requires treatment with supplemental oxygen.
Have known allergies to any of the components used in the formulation of the interventions.
Have hemodynamic instability requiring use of vasopressors within 24 hours of randomization.
Suspected or proven serious, active bacterial, fungal, viral, or other infection (except COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention (i.e. known history of human immunodeficiency virus [HIV]).
Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 30 days.
Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
Subjects with myopathy.
Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening.
Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Subject taking an anti-androgen of any type including androgen depravation therapy, 5-alpha reductase inhibitors, etc. within 3 months before dosing.
Are investigator site personnel directly affiliated with this study.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy in terms of clinical status following treatment with GT0918 compared to placebo   Study Duration: 42 Days  
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the clinical efficacy of GT0918 compared to placebo using the NIAID 8- point scoring scale
2. To evaluate the clinical efficacy of GT0918 compared to placebo based on clinical status
3. Characterize the effect of GT0918 compared to placebo on symptom improvement or resolution
4. Characterize the effect of GT0918 compared to placebo on SARS CoV-2 viral load clearance
5. Characterize the effect of GT0918 compared to placebo on safety

 		 Study Duration: 42 Days  
 
Target Sample Size   Total Sample Size="668"
Sample Size from India="200" 
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 3 
Date of First Enrollment (India)   31/01/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/04/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a Phase 3 Study to Evaluate the Efficacy and Safety of GT0918 in OutpatiThis is a Phase 3 Study to Evaluate the Efficacy and Safety of GT0918 in Outpatients with Mild to Moderate COVID-19 Illness ents with Mild to Moderate COVID-19 Illness. 
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