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CTRI Number  CTRI/2020/06/025664 [Registered on: 05/06/2020] Trial Registered Prospectively
Last Modified On: 19/05/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Phase II study to evaluate the Safety and Efficacy of 2-Deoxy-D-Glucose in COVID -19 patients 
Scientific Title of Study
A Randomized, Open Label, 2-Treatment Groups Clinical Trial Evaluating the Safety and Efficacy of 2-Deoxy-D-Glucose as an adjunctive therapy to standard of care, in comparison to standard of care alone, in the Acute Treatment of moderate to severe COVID -19 patients 
Secondary IDs if Any
Secondary ID  Registry 
CVD-19-CD-002, Version 5.0, 22 July 2020  Protocol Number 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  

Details Contact Person
Scientific Query

Name  D Mallikarjuna Rao 
Address  Proprietary Products Regulatory Affairs Innovation Plaza, IPDO Survey No. 54 Bachupally village Bachupally Mandal

Phone  914044346860  
Fax  914044346125  
Email  mallikarjunard@drreddys.com  
Details Contact Person
Public Query

Name  D Mallikarjuna Rao 
Address  Proprietary Products Regulatory Affairs Innovation Plaza, IPDO Survey No. 54 Bachupally village Bachupally Mandal

Phone  914044346860  
Fax  914044346125  
Email  mallikarjunard@drreddys.com  
Source of Monetary or Material Support  
Dr. Reddy’s Laboratories Limited 8-2-337, Road No. 3 Banjara Hills, Hyderabad 500043 
Primary Sponsor  
Name  Dr Reddys Laboratories Limited 
Address  8-2-337, Road No.3, Banjara Hills, Hyderabad-500 034, Telangana, India 
Type of Sponsor  Pharmaceutical industry-Global 
Details of Secondary Sponsor  
Name  Address 
Institute of Nuclear Medicine and Allied Sciences  DRDO, Ministry of Defence, Brig. S K Mazumdar Marg, Timarpur, Delhi-110054 
Countries of Recruitment     India  
Sites of Study
No of Sites = 12  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Akshay Budhraja  Aakash Healthcare Super Speciality Hospital  Department of Respiratory and Sleep Medicine, Hospital Plot Rd Number 201, Sector-3 Dwarka
New Delhi

Dr G Balachandra   BGS Global Institute of Medical Sciences  Professor and HOD, General Medicine, #67, BGS Health and Education City, Uttarhalli Road, Kengeri, Bengaluru – 560060
Dr Vinoth Kumar Athinarayanan  Chengalpet Government Medical College & Hospital  Senior Resident, Department of Chest and TB GST Road, Chengalpattu, Kancheepuram, Tamilnadu-603001

Dr Apurva Agarwal  Ganesh Shankar Vidyarthi Memorial Medical College  Department of Anesthesiology Professor and Head Swaroop Nagar, Kanpur
Kanpur Nagar

Dr Rajesh Gosavi  Government Medical College and Hospital, Nagpur  Professor of Medicine Hanuman Nagar, Ajni Rd, Medical Chowk, Ajni

Dr Meenakshi Bhattacharya  Govt Medical College and Hospital Aurangabad  Professor and HOD of Medicine, University Road, Jubilee Park

Dr Viny Kantroo  Indraprastha Apollo Hospitals  Consultant, Department of Respiratory Medicine, Sarita Vihar, NEW DELHI 110076

Dr Ajay Jhaveri  Kasturba Hospital of Infectious Diseases  Consultant Physician and Gastroenterologist, Sane Guruji Marg, Arya Nagar, Chinchpokli
Dr Y G Sundara Raju  King George Hospital  Department of General Medicine, Rajendra Prasad Ward, KGH Down Rd, Opp KGH OP Gate, Maharani Peta

Dr Sudhir Kumar Verma  King George Medical University (Erstwhile Chhatrapati Shahuji Maharaj Medical University)  Associate Professor, Department of Medicine, Shah Mina Rd, Chowk

Dr Jigar Modia  Medistar Hospital  GIDC Vadsar Road, Flyover, adjoining Vadsar, Vadodara, Gujarat 390010

Dr Kapil Zirpe  Ruby Hall Clinic  Head, Dept of Neuro Critical Care 40, Sasoon Rd, Sangamvadi

Details of Ethics Committee
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Aakash Healthcare Institutional Ethics Committee  Approved 
Anand Institutional Ethics Committee  Approved 
Ethics Committee GSVM Medical College  Approved 
IEC King George hospital  Approved 
IEC, Jaslok Hospital and Research Centre  Approved 
Institutional Ethics Committee (IEC-GMCA)  Approved 
Institutional Ethics Committee, BGS Global Institute of Medical Sciences  Approved 
Institutional Ethics Committee, Govt. Medical College, Nagpur  Approved 
Institutional Ethics Committee-Chengalpattu Medical College  Approved 
Institutional Ethics Committee-Clinical Studies, Indraprastha Apollo Hospital, New Delhi  Approved 
King Georges Medical University Institutional Ethics Committee  Approved 
Poona Medical Research Foundation Institutional Ethics Committee  Approved 
Regulatory Clearance Status from DCGI
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Coronavirus as the cause of diseases classified elsewhere 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  2-Deoxy-D-Glucose Oral Powder  45 mg/kg Morning + 18 mg/kg Evening as long as SoC is being administered, but no longer than discharge or Day 28 (whichever is earlier) 
Comparator Agent  Standard of Care  Upto Day 28 discharge but no more than Day 28 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male, female and transgender patients aged ≥ 18 years and ≤ 65 years
2. Patients testing positive for SARS-CoV-2 by rRT-PCR on a nasopharyngeal or oropharyngeal swab
Note: A re-treated/ relapsed patient may be enrolled if he/she meets all of the following criteria:
a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARS-CoV-2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARS-CoV-2 after previous treatment
b. Clinical symptoms associated with COVID-19 (fever, cough, difficulty in breathing, fatigue, body ache, headache, diarrhea, nasal congestion) have either re-appeared after previous treatment OR continued to be present without improvement OR are aggravated
c. Patient meet the below-mentioned criterion (# 3) for ‘moderate’ or ‘severe’ COVID-19 disease severity
3. Patients clinically assigned as ‘moderate’ (Pneumonia with no signs of severe disease, respiratory rate 15 to 30/minute, SpO2 90%-94%) or ‘severe’ (Severe Pneumonia with respiratory rate ≥30/minute and/or SpO2 < 90% in room air) but not critically ill (acute respiratory distress syndrome [ARDS], multi organ failure or septic shock)
Note: The severity is as defined by the Guidance document on appropriate management of suspect/confirmed cases of COVID-19 published by the Ministry of Health & Family Welfare on 07 Apr 2020.
4. Females should have a negative serum pregnancy test at baseline; female patients of child bearing potential should either be abstinent or comply with one or more contraception methods (with low user dependency and failure rate of <1%) for the entire duration of the treatment period and until 90 days after receiving the last dose of study treatment
5. Able and willing to provide informed consent
6. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator
7. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment 
Details  1. Critically ill patients, defined as those who are candidates for endotracheal intubation and invasive mechanical ventilation and those with ARDS, septic shock or multi-organ failure at baseline
2. Patients with previous history of hypersensitivity or a contra-indication to the IMP 2-deoxy-D-glucose or the imaging marker Fludeoxyglucose (FDG)
3. Patients with history of one or more known comorbidities at baseline:
a. Cardiac Failure
b. Prior or concurrent ischemic coronary artery disease (CAD): angina pectoris, history of myocardial infarction or documented silent ischemia or coronary artery vasospasm, including Prinzmetal’s angina
c. Cardiac conduction delay (QTc > 500 msec) or taking any prescription medications known to prolong QT interval
d. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
e. Diabetes Mellitus or any condition predisposing to hypoglycaemia
f. Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD)
g. Asthma or Interstitial Lung Disease
h. Malignancy
i. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition)
j. Presence of any contra-indication to the chosen Standard of Care treatment
4. Patients who are receiving drugs known to prolong the QT interval of heart including hydroxychloroquine or azithromycin OR are expected to require treatment with the same during the treatment period in the study (as of baseline assessment).
5. Received biological therapy (especially, experimental ACE-2 decoy or decoy receptor/monoclonal antibody against interleukin-6, interferon alpha) or convalescent plasma (for COVID-19 treatment) in the 90 days (prior to baseline visit).
6. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients. This includes patients receiving other investigational therapies for COVID-19.
7. Inability to take oral medication.
8. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption
9. Body Weight < 45 kg or >130 kg
10. Female patients who are pregnant or lactating
11. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg. Methotrexate, Cyclosporine, etc.)
12. Patients who are contemplating surgery/ female patients contemplating a pregnancy within 90 days after scheduled end of study treatment
13. Patients who are not suitable to participate in the study based on the Investigator’s judgeme 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome
Outcome  TimePoints 
Time to ‘Clinical improvement  Day 3,7,10,14 and 28 (until patient reaches score of 4 or lower on 10 point ordinal scale for clinical status or discharge, whichever is earlier). 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline in mean viral load (determined by rRT-PCR on nasopharyngeal/oropharyngeal swab)  Days 3, 7, 10, 14 and 28 
Changes of parameters at each assessment during the study/follow-up period, compared to baseline for:
o Vital signs: body temperature, heart rate, respiratory rate, systolic/diastolic blood pressure and oxygen saturation.
o Clinical laboratory assessments: hematology, serum chemistry, urinalysis.
o 12-lead ECG: Changes in heart rate, PR, QRS, QT and QTcB intervals. 
Days 3, 7, 10, 14 and 28 
Mean change from baseline in NEWS-2 score  Days 3, 7, 14, 21 and 28 (or discharge, if discharge happens before) 
Mean change from baseline in patient’s clinical status on a 10-point ordinal scale (SOLIDARITY trial)  Days 3, 7, 14, 21 and 28 (or discharge, if discharge happens before)  
Mean/ median time (no. of days) from start of study treatment to clinical status score improvement by 1 and by 2 (from baseline) on the 10-point ordinal scale used in the SOLIDARITY trial by WHO  Day 1 to Day 28 
Mean/ median time (no. of days) the patient is:
a. Managed in intensive care unit
b. On Oxygen supplementation
c. On Invasive mechanical ventilation 
Day 28 
Mean/ Median Time to achieve symptom improvement of at least 30% in the COVID-19 symptoms sum score from baseline  Day 14 
Mean/median time (no. of days) from start of study treatment to discharge from the ‘isolation ward’ of the COVID management facility.  Day 1 to Day 28 
Mean/Median time (no. of days) to negative conversion (of detectable SARS-CoV-2 viral RNA) on nasopharyngeal swab from day of first treatment intake  Day 1 to Day 28 
Mean/median time (no. of days) to
a. Management in intensive care unit
b. Oxygen supplementation
c. Invasive mechanical ventilation 
Day 28 
Number (and percentage) of patients reporting treatment emergent adverse events (TEAEs) (by MedDRA system organ class and preferred term)  Days 3, 7, 10, 14 and 28 
Percentage of patients dying due to COVID-19 complication  Day 1 to Day 28 
Percentage of patients requiring, until Day 28 of treatment:
a. Management in intensive care unit (ICU)
b. Oxygen supplementation
c. Invasive mechanical ventilation 
Day 28 
Percentage of patients showing negative conversion (of detectable SARS-CoV-2 viral RNA) on nasopharyngeal/oropharyngeal swab  Day 10 and Day 28 
Percentage of patients who achieve the endpoint of Clinical improvement  Day 14 and by Day 28 
Target Sample Size
Total Sample Size="40"
Sample Size from India="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/06/2020 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="0"
Recruitment Status of Trial (Global)
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Brief Summary  
COVID-19 is currently a major global public health crisis and in the absence of an effective vaccine and ‘herd’ immunity, there are no known interventions for effectively dealing with this pandemic (other than broad public-health measures like physical distancing and containment). At an individual COVID-19 patient level, there is a lack of proven specific treatment options that improve symptoms, influence disease severity progression and clinical outcomes or aid the treating physician in better patient management. Different medicines and medicinal systems are being explored to find remedial measures for this new infection. Antiviral drugs, and other antimicrobial agents are being evaluated and being utilized off-label in treating patients, largely those with more severe COVID-19. However, no breakthrough has been achieved to date either in curtailing the pandemic or improving patient outcomes.
2-deoxy-D-glucose (2-DG), an inhibitor of glucose transport and glycolysis, is known to inhibit the growth of neoplastic cells in vitro and in vivo. While 2-DG is not an approved drug, it has been studied in 218 clinical trials for the treatment of various cancers globally. 2-DG has not been evaluated in the acute treatment of moderate to severe COVID-19. However, based on mechanistic and in-vitro-evidence (see below) as well efficacy seen in the interventional clinical studies in malignancies and genital herpes, the Sponsors believe that 2-DG could be developed for the specific treatment of patients with COVID-19 disease in conjunction with other anti-viral therapies.
2-DG was chosen based on its in vitro inhibition potential (EC50 = 1.0 mM, EC90 = 3.7 mM; supernatant) towards SARS-CoV-2 from the studies conducted by Institute of Nuclear Medicine & Allied Sciences (INMAS), Delhi of the Defence Research and Development Organization (DRDO) at Centre for Cellular and Molecular Biology, Hyderabad. The Sponsor of this study, INMAS, DRDO, Ministry of Defence, Govt of India, was responsible for genesis of this hypothesis and testing of efficacy of 2-DG against SARS-CoV2. These effective concentrations are within the range that can be achieved in human plasma upon oral dosing of 63 mg/kg/day.
Moreover, Positron Emission Tomography (PET) with the radiotracer, 18FDG (Fludeoxyglucose, an analog of 2-DG) has shown accumulation of the radiolabel in the inflamed lungs of COVID-19 patients, due to high metabolic activity induced by the coronavirus infection. Dr Reddy’s believes that this phenomenon could potentially result in a preferential and disproportionately high accumulation of 2-DG in inflamed lung tissue of COVID-19 patients thereby leading to starvation in the lung cells, which in turn would lead to inhibition of viral replication.