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CTRI Number  CTRI/2021/07/034611 [Registered on: 06/07/2021] Trial Registered Prospectively
Last Modified On: 06/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to assess the safety and efficacy of a nutraceutical formulation in addition to standard of care in COVID-19 positive patients. 
Scientific Title of Study   Single-center, double blinded, two arm placebo controlled clinical study to assess the safety and efficacy of XAR-XAP nutraceutical formulation in COVID-19 patients  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhijeet Joshi 
Designation  Consulting Physician  
Affiliation  Maharashtra Medical Research Society 
Address  Joshi Hospital, OPD no 4, 3rd floor Firodiya building MMRS Joshi hospital Opposite Kamala Nehru Park Shivaji nagar Pune- 411004
Ratna Hospital, 968, Senapati Bapat Rd, Sheti Mahamandal, Shivaji Cooperative Housing Society, Ramoshivadi, Pune - 411053
Pune
MAHARASHTRA
411004
India 
Phone  020-41096666  
Fax    
Email  joshabhijeet@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sagar Chhabria 
Designation  Vice President Research And Development 
Affiliation  Epigeneres Biotech Pvt. Ltd. 
Address  Marathon Innova, C-Wing, Office No.: 701, 7th Floor, Ganpatrao Kadam Marg, Lower Parel.

Mumbai
MAHARASHTRA
400013
India 
Phone  9869820610  
Fax    
Email  sagar@epigeneres.com  
 
Details of Contact Person
Public Query  
Name  Dr Nripen Sharma  
Designation  Senior Scientist 
Affiliation  Epigeneres Biotech Pvt. Ltd. 
Address  Marathon Innova, C-Wing, Office No.: 701, 7th Floor, Ganpatrao Kadam Marg, Lower Parel

Mumbai
MAHARASHTRA
400013
India 
Phone  9967481283  
Fax    
Email  nripen@epigeneres.com  
 
Source of Monetary or Material Support  
Epigeneres Biotech Pvt Ltd 
 
Primary Sponsor  
Name  Epigeneres Biotech Pvt Ltd  
Address  Marathon Innova, C-Wing, Office, No. - 701, Ganapatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra 400013 
Type of Sponsor  Other [Biotechnology Company ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhijeet Joshi  Joshi Hospital  Joshi Hospital, OPD no 4, 3rd floor Firodiya building MMRS Joshi hospital Opposite Kamala Nehru Park Shivaji nagar Pune- 411004
Pune
MAHARASHTRA 		 9421217976

joshabhijeet@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Maharashtra Medical Research Society (MMRS)  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 
Comparator Agent  Maltodextrin (placebo)  4 capsules of Maltodextrin thrice a day along with standard of care for 30 days Route of administration: oral 
Intervention  XAR-XAP  4 capsules of XAR-XAP thrice a day along with standard of care for 30 days Route of administration: oral 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects with acute uncomplicated moderate Corona infections needing hospitalization with temperature ≥ 38 ℃ (100.4 °F); plus at least one respiratory symptom (nasal congestion, sore throat, cough, breathing difficulty {Respiratory Rate ≥24 breaths per minute or Saturation of Oxygen (SpO2) <94% on room air}); and at least one constitutional symptom (aches or pains, fatigue, headache, chills or sweats). If antipyretics were taken, may wait at least 4 hours after dosing to determine if a qualifying temperature is observed.
2. Subjects with laboratory confirmed SARS-CoV-2 infection (COVID-19) as determined by the Reverse Transcription Polymerase Chain Reaction (RT-PCR) or other approved commercially available or public health assay prior to Visit 1.
3. Onset of symptoms at least 48 hours but no more than 96 hours before Visit 1 (Screening; study drug administration visit). The onset of symptoms is defined as either:
3a. Time of the first increase in body temperature to ≥ 38 ℃ (100.4 °F); or
3b. Time when the subject experiences at least one general or respiratory symptom.
4. Subjects can have any vaccination status: not vaccinated, partially vaccinated (taken first dose), completely vaccinated (taken both doses).
5. Subjects who are able to understand and willing to sign the informed consent form (ICF).
6. Subjects who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations and other study procedures.
7. All female subjects of child-bearing potential must have a negative urine pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 30 days for females and 90 days for males after study drug discontinuation.
 
 
ExclusionCriteria 
Details  1. Severe COVID-19 infection.
2. History of Chronic Exposure to Smoking
3. other concurrent infections requiring systemic antiviral therapy prior to screening.
4. Administration of immunomodulators, interferon inducers, homeopathic, hormonal other than hormone replacement therapy, and antiviral drugs during the previous 4 weeks before the first dose. Use of corticosteroids as part of the current standard of care is permitted.
6. Allergy or known allergy to components of study medication (Peanuts and Mushroom).
7. Subjects with severe symptoms such as respiratory rate > 30 breaths per minute or saturation of oxygen (SpO2) < 90% on room air. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To investigate the clinical efficacy of XAR-XAP treatment in reducing the duration and severity of illness compared to placebo   Day 0, Day 15, Day 30, Day 60, Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
To investigate the effect of XAR-XAP treatment on the anti SARS-CoV-2 antibody levels in COVID-19 subjects on Day 0, Day 30, day 60 and day 90
To monitor long term protection (until 90 days) of COVID-19 patients with or without controlled diabetes and hypertension. 		 Day 0, Day 15, Day 30, Day 60, Day 90 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   15/07/2021 
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="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sagar@epigeneres.com].

  6. For how long will this data be available start date provided 15-06-2021 and end date provided 15-06-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The clinical study will have a total of 28 subjects; divided into 2 groups having 14 subjects each, wherein group 1 would receive the placebo, group 2 would receive XAR-XAP. The study would be carried out in Maharashtra itself and would go on for a period of 90 days, wherein the treatment would be given for 30 days along with the standard of care, and for the remaining 60 days we would monitor the antibody levels in the patients. Patients diagnosed with recent mild to moderate COVID infection requiring isolation or home quarantine. 
 
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