CTRI/2021/01/030231 [Registered on: 04/01/2021] Trial Registered Prospectively
Last Modified On:
26/05/2021
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A randomized, two treatment group clinical study to evaluate the effectiveness and safety of study drug 2-Deoxy-D-Glucose with SOC compared to SOC alone in treatment of moderate to severe COVID-19 patients
Scientific Title of Study
A Randomized, Open Label 2-Treatment Group Clinical Trial Evaluating the Efficacy and Safety 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
Dr Reddys Laboratories Limited IPDO, Innovation Plaza Bachupally Hyderabad
Hyderabad TELANGANA 500090 India
Phone
Fax
Email
mallikarjunard@drreddys.com
Source of Monetary or Material Support
Institute of Nuclear Medicine and Allied Sciences (INMAS), DRDO, Ministry of Defence, Brig. S K Mazumdar Marg, Timarpur, Delhi-110054
and Dr. Reddy’s Laboratories Limited, 8-2-337, Road No.3, Banjara Hills, Hyderabad-500 034, Telangana, India
Primary Sponsor
Name
Institute of Nuclear Medicine and Allied Sciences INMAS
Address
DRDO, Ministry of Defence, Brig. S K Mazumdar Marg, Timarpur, Delhi-110054
Type of Sponsor
Government funding agency
Details of Secondary Sponsor
Name
Address
Dr Reddys Laboratories Limited
8-2-337, Road No.3, Banjara Hills,
Hyderabad-500 034,
Telangana, India
Pvt. Ltd, Hospital Plot, Road No. 201, Sector 3, Dwarka, New Delhi -110075, India New Delhi
9893322007
dr.akshaybudhraja@gmail.com
Dr Shilpa Wamanrao Bawankule
Acharya Vinoba Bhave Rural Hospital, A Teaching Hospital of Jawaharlal Nehru Medical College,
Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital, A Teaching Hospital of Jawaharlal Nehru Medical College, Sawangi (M), Wardha- 442004, Maharashtra, India Wardha
9673288822
drshilpagaidhane@gmail.com
Dr Sunita Dinkar Kumbhalkar
All India Institute of Medical Science
MIHAN, Sumthana, Nagpur-441108 Nagpur
9850336899
skumbhalkar@gmail.com
Dr Parshottam Govindbhai Koradia
BAPS Pramukh Swami Hospital
(a unit of Bochasanwasi Shri Akshar Purshottam Public Charitable Trust), Shri Pramukh Swami Maharaj Marg, Adajan Char Rasta, Adajan, Surat- 395009 Surat
Aakash Healthcare Super Speciality Hospital Institutional Ethic Committee, Department of Academic and research Development, Basement 1, Near Ultrasound, Hospital Plot, Road No 201, Sector 3, Dwarka, New Delhi 110075, India
Approved
Clinical Research Ethics Committee Medica Superspeciaity Hospital, Kolkata
Approved
Ethics Committee St Theresa’s Hospital, Sanath Nagar, Opp to Erragadda Raitu Bazar, Hyderabad, 500018, Telangana, India
Approved
Ethics Committee, SP Medical College & AG Hospitals, HRMC Cardiovascular Sciences & Research Center, Bikaner- 334003, Rajasthan, India.
Submittted/Under Review
Institution Ethics Committee Poona Medical Research Foundation, E-4 C to E-4 F, 4th Floor, 5th Avenue Condominium, Dhole Patil Road, Pune- 411001, Maharashtra, India
Approved
Institutional Clinical Ethics Committee, Thane Municipal Corporation, Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital, Thane Belapur Road, Kalwa, Thane- 400605, Maharashtra, Indi
Submittted/Under Review
Institutional Ethics committee Suretech Hospital & Research Centre Pvt. Ltd. 13-A, Banerjee Marg, Dhantoli, Nagpur-440012, Maharashtra, India
Institutional Ethics Committee, Chengalpattu Medical College and Hospital, No. 01 G.S.T Road, Chengalpattu -603001, Tamil Nadu, India.
Submittted/Under Review
Institutional Ethics Committee, Datta Meghe Institute of Medical Sciences (DU), Research House, Near Food Court, Datta Meghe Institute of Medical Sciences (DU), Sawangi- 442004, Maharashtra, India
Submittted/Under Review
Institutional Ethics Committee, King George Hospital, Maharanipeta collecter office Junction, Visakhapatnam-530002, India.
Submittted/Under Review
Institutional Ethics Committee, Medical College Building, 5th Floor, Department of Pharmacology, Plot No.2, Sector-5,Navi Mumbai – 400706, Maharashtra, India.
Approved
Institutional Ethics Committee, NKP Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur-440019, Maharashtra, India
Approved
Institutional Human Ethics Committee GMERS Medical College and Hospital, Gotri, Old TB Hospital Campus Gotri Main Road, Gotri, Vadodara - 390021, Gujarat, India.
Approved
Institutional Review Board, Mahatma Gandhi Cancer Hospital & Research Institute, 1/7, MVP Colony, Vishakhapatnam- 530017, Andhra Pradesh, India
Approved
Maharaja Agrasen Hospital Institutional Ethics Committee, Maharaja Agrasen Hospital, Room No: 614, 6th Floor, West Punjabi Bagh, New Building, New Delhi-110026, India.
90 mg/kg body weight/ day 2-Deoxy-D-Gluclose and SOC
2-Deoxy-D-Gluclose 45 mg/kg body weight AM plus 45 mg/kg body weight PM for 10 days or until discharge, whichever earlier
SOC as required
Comparator Agent
Standard of Care Only
for 10 days or until discharge
Inclusion Criteria
Age From
18.00 Year(s)
Age To
90.00 Year(s)
Gender
Both
Details
1. Male, female and transgender patients aged ≥ 18 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 SARSCoV
2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARSCoV-2 after previous treatment
AND
b. Clinical symptoms associated with COVID-19 (fever, cough, fatigue, shortness of breath, expectoration, myalgia, rhinorrhea, sore throat, diarrhea, anosmia, ageusia) have either re-appeared after previous treatment
OR continued to be present without improvement OR are aggravated
c. Patient meet the below-mentioned criterion number 3 for moderate or severe COVID-19 disease severity
3. Patients clinically assigned as moderate [Presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% range 90-94% on room air, Respiratory Rate more or equal to 24 per minute] or severe (Clinical signs of Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air) but not critically ill (acute respiratory distress syndrome [ARDS], multi organ failure or septic shock)
4. Patients with a score of ≥ 5 (‘hospitalized, on oxygen’) on the 10- point ordinal scale of clinical status used by WHO in the SOLIDARITY trial at baseline assessment.
5. 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
6. Able and willing to provide informed consent
7. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator
8. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment
ExclusionCriteria
Details
Patients who meet any of the following criteria will be disqualified from
entering the study:
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 in whom the first onset of symptoms/signs suggestive of COVID-19 illness was observed >10 days earlier to the baseline assessment and randomization
3. Patients with previous history of hypersensitivity or a contraindication
to the IMP 2-deoxy-D-glucose or the imaging marker Fluorodeoxyglucose (FDG)
4. 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 medications known to prolong QT interval
d. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
e. Uncontrolled 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. Chronic Kidney Disease
j. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition)
k. Presence of any contra-indication to the chosen Standard of Care treatment
5. 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).
6. Received interferon alpha or experimental biological therapies ( eg. ACE-2 decoy or monoclonal antibodies against SARS-CoV-2) in the 90 days prior to baseline visit.
Note: Convalescent plasma therapy and drugs/ biological therapies that have received approval for ‘emergency use’ for the treatment of COVID-19 from the Drug Regulatory Authority are permitted as part of Standard of care or as ‘rescue’ treatments in the trial.
7. 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.
8. Inability to take oral medication.
9. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption
10. Body Weight < 45 kg or >130 kg
11. Female patients who are pregnant or lactating
12. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg. Methotrexate, Cyclosporine, etc.)
13. Patients who are contemplating surgery/ female patients contemplating a pregnancy within 90 days after scheduled end of study treatment
14. Patients who are not suitable to participate in the study based on the Investigator’s judgement
1. To evaluate the efficacy of 2-Deoxy-D-Glucose (2-DG) as an adjunctive therapy to standard of care (SoC), in comparison to SoC alone, in the acute treatment of moderate to severe COVID-19 patients
2. To evaluate the safety of 2-DG as an adjunctive therapy to standard of care (SoC), in comparison to SoC alone, in the acute treatment of moderate to severe COVID-19 patients
This is a prospective, interventional,
multi-centre, phase III, randomized, open-label, two treatment group, parallel
design trial to evaluate the efficacy, safety and tolerability of 2-DG
administered as adjunctive (or “add-on”) therapy to standard of care, in
comparison to standard of care alone, in the acute treatment of patients
testing positive for SARS-CoV-2 and presenting with moderate or severe
COVID-19. An interim analysis will be planned for futility assessment and re-estimationof
sample size.
