Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: 2-Deoxy-D-Glucose (2-DG) powder for oral Solution: 2-deoxy-D-glucose (2-DG) powder for oral solution will be made available for the current study as sachets containing 2.34 g and will b
Sponsors
Dr Reddys Laboratories Limited
Institute of Nuclear Medicine and Allied Sciences INMAS DRDO Ministry of Defence
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients willing and able to provide voluntary written informed consent (assent in case of patients aged 12- 2. Male or female patients aged 12 years of age or older 3. Patients with positive RT-PCR test for SARS-CoV-2 on nasopharyngeal or oropharyngeal swab sample (with sample being collected 4. Patients with â??mildâ?? COVID-19 disease severity, as defined by Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI; , AND having any of the following symptoms and signs prior to randomization: Fever, cough, sore throat/throat irritation, body ache/headache, malaise/weakness, diarrhoea or gastrointestinal upset, with or without anorexia/nausea/vomiting, with or without loss of smell and/or taste, no shortness of breath/breathlessness Respiratory rate of less than 24/min, SpO2 >= 94% on room air. 5. Patients (12 to Children presenting with fever, sore throat, diarrhoea, anorexia/nausea/vomiting, loss of sense of smell and/or taste, malaise/weakness, body ache/headache, rhinorrhea, cough with no breathing difficulty (grunting, severe retractions of chest), somnolence, lethargy and seizures Respiratory rate = 94% on room air 6. Patients with SpO2 >= 94% on two consecutive pulse-oximetric measurements performed at least two hours apart, on room air, when assessed prior to randomization. 7. Is willing and able to take oral medication 8. In case of female patients of child-bearing potential, a negative urine pregnancy test prior to beginning the therapy. 9. Patient agrees to completely abstain from sexual activity or to take effective contraception measures (including hormonal contraception or double barrier method) with his/her partner during the study period. As per latest Guidance documents updated periodically by Directorate General of Health Services, MoHFW, GOI
Exclusion criteria
Exclusion criteria: 1. Patients with â??moderateâ?? or â??severeâ?? COVID-19 disease severity, as defined by latest Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI and Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI at the time of randomization. This includes any one or more of the following: A) Peripheral Blood oxygen saturation B) Respiratory Rate >= 24 breaths per minute for adults and >= 30 breaths per minute for patients aged 12 to C) Presence of shortness of breath (dyspnea) at rest, as a symptom D) Grunting, severe retraction of chest, lethargy, somnolence and Seizure in patients aged 12 to 2. Patients with first onset of symptom(s) known to be associated with COVID-19 was >5 days prior to the day of randomization 3. Patients who are currently hospitalized/ need hospitalization OR are expected to deteriorate to need hospitalization for COVID-19 management within 48 hours after randomization, in the opinion of the Investigator 4. Patients with previous history of hypersensitivity or contra-indication to the IMP 2-deoxy-D-glucose or to the imaging marker fluorodeoxyglucose (FDG). 5. Patients with : A) Presence of Uncontrolled diabetes mellitus B) Presence or History of any Cardiac conduction disorders OR QTc interval >500 ms at baseline assessment C) Presence of gastrointestinal disorder that could affect absorption of orally administered 2-DG solution D) Presence or history of any other disease or condition which, in the opinion of the Investigator, could prevent, limit or confound protocol-specified assessments or could jeopardize the safety of patient if (s)he were to participate in the study 6. Pregnant and Lactating patients. 7. Patients not expected to survive longer than 48 hours (due to any reason) at the time of randomization, in the opinion of the Investigator 8. Patients who are receiving drugs that are known to prolong QT interval of the heart (including hydroxychloroquine) or are expected to require treatment with the same during the study period 9. Patients that are currently or have participated in such studies participating in other clinical studies with investigational drug, biological agent or device within 1 month or within 5 half-lives (of the drug/biologic) prior to randomization (whichever is longer). 10. Patients with body weight 105 kg. Categorization of COVID-19 disease severity as â??mildâ??, â??moderateâ??, â??severeâ?? is as per the â??Comprehensive Guidelines for Management of COVID-19 patientsâ?? (In Adults) Directorate General of Health Services, MoHFW, GOI and COVID-19 disease severity, as defined by â??Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of oral 2-DG in comparison to placebo in preventing worsening of COVID-19 clinical disease severity, in RT-PCR confirmed SARS-CoV-2 patients having mild COVID-19 disease, when administered as adjunctive treatment to standard of care managementTimepoint: Randomization to Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of oral 2-DG in comparison to placebo in improving clinical and virological outcomes and preventing COVID-19 disease progression in patients with mild COVID- 19 disease, when administered as adjunctive treatment to standard of care managementTimepoint: Randomization to Day 14 | — |
Countries
India
Contacts
Public ContactDr D Mallikarjuna Rao
Dr. Reddyâ??s Laboratories Limited
Outcome results
None listed