COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50985

Dr D Mallikarjuna Rao

anant@inmas.drdo.in

2021-01-04

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Male, female and transgender patients aged â?¥ 18 years <br/ >2. Patients testing positive for SARS-CoV-2 by rRT-PCR on a nasopharyngeal or oropharyngeal swab <br/ >Note: A re-treated/ relapsed patient may be enrolled if he/she meets <br/ >all of the following criteria: <br/ >a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARSCoV <br/ >2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARSCoV-2 after previous treatment <br/ >AND <br/ >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 <br/ >OR continued to be present without improvement OR are aggravated <br/ >c. Patient meet the below-mentioned criterion number 3 for moderate or severe COVID-19 disease severity <br/ >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) <br/ >4. Patients with a score of â?¥ 5 (â??hospitalized, on oxygenâ??) on the 10- point ordinal scale of clinical status used by WHO in the SOLIDARITY trial at baseline assessment. <br/ >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 <br/ >6. Able and willing to provide informed consent <br/ >7. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator <br/ >8. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment <br/ >

Patients who meet any of the following criteria will be disqualified from <br/ >entering the study: <br/ >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 <br/ >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 <br/ >3. Patients with previous history of hypersensitivity or a contraindication <br/ >to the IMP 2-deoxy-D-glucose or the imaging marker Fluorodeoxyglucose (FDG) <br/ >4. Patients with history of one or more known comorbidities at <br/ >baseline: <br/ >a. Cardiac Failure <br/ >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 <br/ >c. Cardiac conduction delay (QTc > 500 msec) or taking any medications known to prolong QT interval <br/ > d. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders <br/ >e. Uncontrolled Diabetes Mellitus or any condition predisposing to hypoglycaemia <br/ >f. Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) <br/ >g. Asthma or Interstitial Lung Disease <br/ >h. Malignancy <br/ >i. Chronic Kidney Disease <br/ >j. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ >k. Presence of any contra-indication to the chosen Standard of Care treatment <br/ >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). <br/ >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. <br/ >Note: Convalescent plasma therapy and drugs/ biological therapies that have received approval for â??emergency useâ?? for the treatment of COVID-19 from the Drug Regulatory Authority are permitted as part of Standard of care or as â??rescueâ?? treatments in the trial. <br/ >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. <br/ >8. Inability to take oral medication. <br/ >9. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ >10. Body Weight < 45 kg or >130 kg <br/ >11. Female patients who are pregnant or lactating <br/ >12. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg. Methotrexate, Cyclosporine, etc.) <br/ >13. Patients who are contemplating surgery/ female patients contemplating a pregnancy within 90 days after scheduled end of study treatment <br/ >14. Patients who are not suitable to participate in the study based on the Investigatorâ??s judgement <br/ >

2

Institute of Nuclear Medicine and Allied Sciences INMAS

18

90

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

220

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 <br/ >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 <br/ >Timepoint: entire duration of Trial

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 3, "treatment_name": "2-deoxy-d-glucose", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]