Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: 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)
Control Interventi
Sponsors
Dr Reddys Laboratories Limited
Institute of Nuclear Medicine and Allied Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male, female and transgender patients aged >= 18 years and 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 AND 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 AND c. Patient meet the below-mentioned criterion (# 3) for â??moderateâ?? or â??severeâ?? COVID-19 disease severity 3. Patients clinically assigned as â??moderateâ?? (Pneumonia with no signs of severe disease, respiratory rate 15 to 30/minute, SpO2 90%-94%) or â??severeâ?? (Severe Pneumonia with respiratory rate >=30/minute and/or SpO2 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 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
Exclusion criteria
Exclusion criteria: 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 Prinzmetalâ??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 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 Investigatorâ??s judgeme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to â??Clinical improvementTimepoint: 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
| Measure | Time frame |
|---|---|
| Change from baseline in mean viral load (determined by rRT-PCR on nasopharyngeal/oropharyngeal swab)Timepoint: 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.Timepoint: Days 3, 7, 10, 14 and 28;Mean change from baseline in NEWS-2 scoreTimepoint: Days 3, 7, 14, 21 and 28 (or discharge, if discharge happens before);Mean change from baseline in patientâ??s clinical status on a 10-point ordinal scale (SOLIDARITY trial)Timepoint: 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 WHOTimepoint: 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 ventilationTimepoint: Day 28;Mean/ Median Time to achieve symptom improvement of at least 30% in the COVID-19 symptoms sum score from baselineTimepoint: Day 14;Mean/median time (no. of days) from start of study treatment to discharge from the â??isolation wardâ?? of the COVID management facility.Timepoint: 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 intakeTimepoint: Day 1 to Day 28;Mean/median time (no. of days) to a. Management in intensive care unit b. Oxygen supplementation c. Invasive mechanical ventilationTimepoint: Day 28;Number (and percentage) of patients reporting treatment emergent adverse events (TEAEs) (by MedDRA system organ class and preferred term)Timep | — |
Countries
India
Contacts
Public ContactD Mallikarjuna Rao
Dr. Reddys Laboratories Limited
Outcome results
None listed