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CTRI Number  CTRI/2020/08/027162 [Registered on: 14/08/2020] Trial Registered Prospectively
Last Modified On: 29/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to understand the effect of Inosine Pranobex in Covid-19 patients when used along with the standard of Care in Covid patients. 
Scientific Title of Study   An Open-Label, Prospective, Randomized, Comparative, Parallel Group, Multi-Center, Proof of Concept Study to Assess the Efficacy and Safety of Inosine Pranobex Added to Current Standard of Care (CSC) in COVID-19 Patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
TML/IAD/2020/01 Version 1.1 24 Jul 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Kumar Swain 
Designation  General Manager- Medical Services 
Affiliation  Themis Medicare Ltd 
Address  Floor 11/12, Udyog Nagar,S. V. Road, Goregaon (W), Mumbai

Mumbai
MAHARASHTRA
400104
India 
Phone  9160255553  
Fax    
Email  ashok.swain@themismedicare.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashok Kumar Swain 
Designation  General Manager- Medical Services 
Affiliation  Themis Medicare Ltd 
Address  Floor 11/12, Udyog Nagar,S. V. Road, Goregaon (W), Mumbai

Mumbai
MAHARASHTRA
400104
India 
Phone  9160255553  
Fax    
Email  ashok.swain@themismedicare.com  
 
Details of Contact Person
Public Query
 
Name  Mr Sangameshwar Iyer 
Designation  Company Secretary 
Affiliation  Themis Medicare Ltd 
Address  Floor 11/12, Udyog Nagar,S. V. Road, Goregaon (W), Mumbai

Mumbai
MAHARASHTRA
400104
India 
Phone  9769692460  
Fax    
Email  sangameshwar.iyer@themismedicare.com  
 
Source of Monetary or Material Support  
Themis Medicare, 11/12, Udyog Nagar, S. V. Road, Goregaon (W), Mumbai – 400104, Maharashtra, India 
 
Primary Sponsor  
Name  Themis Medicare 
Address  11/12, Udyog Nagar, S. V. Road, Goregaon (W), Mumbai – 400104, 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 = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ranganath T Ganga  All India Institute of Medical Science   Room No.1, Department of Pulmonary Medicine, All India Institute of Medical Science, Great Eastern Road, Tetibandha, Raipur
Raipur
CHHATTISGARH 
8004220308

ranganathtg@gmail.com 
Dr Jayanthi C R  Bangalore Medical College and Research Institute   Room No. 1, Director Cabin, Bangalore Medical College and Research Institute, Fort KR Road, Bangalore
Bangalore
KARNATAKA 
9480832400

bmccrj@gmail.com 
Dr Padmaja Saraf  District Hospital, Chikalthana  Room No.1, Department of Medicine, District Hospital Chikalthana, Aurangabad, Near Airport, Jalna Road, Aurangabad
Aurangabad
MAHARASHTRA 
9422216825

drpadmajasaraf@gmail.com 
Dr Mohammad Siddiqui  Heritage Institute of Medical Sciences   Room No 1, Doctors Cabin, Heritage Institute of Medical Sciences, NH-2, GT Road Bypass, Varanasi
Varanasi
UTTAR PRADESH 
9889352598

drshafaatimam@gmail.com 
Dr Mohd Saif Khan  Rajendra Institutes of Medical Science  Room No.1, RIMS CIR, Indraprasth Colony, Bariatu, Ranchi Jharkhand 834009
Ranchi
JHARKHAND 
8870561682

drsaif2k2@gmail.com 
Dr Dnyaneshwar Halnor  Vijay Vallabh Hospital and Medical Research Centre  Room No. 423, Tirupati Nagar, Phase 1, Bolinj, Virar (West)
Mumbai (Suburban)
MAHARASHTRA 
7507779219

halnordnyanu@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee of Bangalore Medical College & Research Institute, Bangalore  Approved 
Ethics Committee of Ishwar Institute of Health Care, Aurangabad  Approved 
Ethics Committee, Rajendra Institute of Medical Sciences (RIMS)  Approved 
Heritage Institute of Medical Sciences Ethics Committee, Varanasi  Approved 
Vijay Vallabh Hospital and Medical Research Centre, Palghar  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  Standard of Care  Standard of Care as per Investigator discretion  
Intervention  Tab. Inosine Pranobex 500 mg in addition with Standard of Care  [Synonyms of API: Inosine Acedoben Dimepranol (INN), Methisoprinol, Isoprinosine] Dose: 500 mg Route: Oral Frequency: 2 Tabltes Four Times in a day. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Written signed and dated informed consent (patient or LAR).
2.Either gender, in the age group between 18 to 65 years
3.Patients of laboratory confirmed COVID-19 [nasopharyngeal (preferred) or oropharyngeal swab RT-PCR positive] presenting with WHO listed symptoms of COVID-19 c/o fever, headache, myalgia, cough, throat pain or shortness of breath
4.A score of between 3 to 5 on the WHO Modified Ordinal Scale for Clinical Improvement (refer protocol appendix 23.1)
5.SpO2 ≥90% for adults and respiratory rate ≤ 30/minute
6.Patients who provide a agree to abide by the study requirements 
 
ExclusionCriteria 
Details  1.Known hypersensitivity to any of the ingredients of the study drug
2.Pregnant and lactating women
3.Children <18 yrs. of age; elderly >65 years
4.SpO2 <90% for adults and respiratory rate >30/minute
5.History of gout or hyperuricemia (serum uric acid level >6mg/dl), urolithiasis, nephrolithiasis or any degree of renal dysfunction
6.Patients with history of diagnosed primary congenital immunodeficiency, or acquired immunodeficiency like HIV, OR any Genetic or developmental anomaly like Cerebral Palsy, coeliac disease, lactose intolerant, cancer in nor remission stage.
7.Patient who are undergoing treatment with xanthine oxidase inhibitors, uricosuric agents, diuretics, immunosuppressive agents or zidovudine.
8.Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
9.Patients simultaneously participating in another clinical study.
10.Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
11.A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Percentage of patients with 2 points improvement or becoming asymptomatic (Grade 2 or less) on the modified WHO ordinal scale for clinical improvement between two groups at day 14  at Day 14 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of patients with 2 points improvement or becoming asymptomatic (Grade 2 or less) on the modified ordinal scale for clinical improvement for two groups at Day 7 and Day 21   Day 7 and Day 21 
Percentage of patients with Grade 1 on WHO modified ordinal scale confirmed (negative swab status) at Day 7, Day 14 and Day 21 for two treatment arms  Day 7, 14 and 21 
Percentage of patients with Grade 2 on WHO modified ordinal scale at Day 7, Day 14 and Day 21 for two treatment arms  Day 7, 14 and 21 
Time to two-point improvement or becoming asymptomatic (Grade 2 or less) on the modified WHO ordinal scale for patients in the two treatment arms  NIL 
Time to resolution of all clinical symptoms of COVID-19 viral infection (Grade 2 on WHO modified ordinal scale) for two treatment arms  NIL 
Time to RT-PCR swab negative COVID-19 viral infection (Grade 1 on WHO modified ordinal scale) for two treatment arms  NIL 
Mortality rate at Day 21  Day 21 
Severity of Dyspnea at Day 7, Day 14 and Day 21  Day 7, 14 and 21 
Time to discharge from hospital/duration of hospitalization for inpatients for two groups  NIL 
Rate of patients requiring oxygen/ventilation, and/or duration of oxygen use/duration of requiring ventilation for two groups at Day 7 and Day 14  Day 7 and 14 
Change in blood levels of NK cell, IL-6 and IL-10 between both treatment groups at Day 7, Day 14 and Day 21 visit.  Day 7, 14 and 21 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2 
Date of First Enrollment (India)   20/08/2020 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 an open-label, prospective, comparative, multicentre proof of concept study. This multicentre study is to assess the effect of Tab. Inosine Pranobex as an add-on therapy to the standard of care for of patients in patients with confirmed acute COVID-19infection achieving clinical response, when compared to patients only on standard of care.

Patients suggestive of RT-PCR [nasopharyngeal (preferred) and oropharyngeal swab positive] acute COVID-19 infection will be enrolled into this study with a score between 3 to 5 on the Modified Ordinal Scale for Clinical Improvement (refer protocol appendix 23.1). Both inpatient and outpatients will be enrolled into this study. The Modified WHO Ordinal Scale for Clinical Improvement, physical and systemic examination will be performed on a daily basis for inpatients and at the scheduled protocol visits for outpatients.

The enrolled patients will receive Tab. Inosine Pranobex treatment for a period of 14 days. Patients will be assessed on day 7 (±1 day) and day 14 (±1 day). A follow-up safety assessment will be done on day 21 (±1 day).

Croissance Clinical Research is providing the Data management Support to the clinical study.
 
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