COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58968

Dr D Mallikarjuna Rao

srinivasshenoyb@drreddys.com

2021-08-25

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Patients willing and able to provide voluntary written informed consent (assent in case of patients aged 12- <18 years old, with written consent obtained for their parent/legal guardian) and comply protocol requirements. <br/ >2. Male or female patients aged 12 years of age or older <br/ >3. Patients with positive RT-PCR test for SARS-CoV-2 on nasopharyngeal or oropharyngeal swab sample (with sample being collected â?¤5 days prior to day of randomization) <br/ >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: <br/ >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 <br/ >Respiratory rate of less than 24/min, SpO2 â?¥ 94% on room air. <br/ >5. Patients (12 to <18 years) with â??mildâ?? COVID-19 disease severity, as defined by Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI, AND having any of the following symptoms and signs prior to randomization: <br/ >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 <br/ >Respiratory rate <30 /min, SpO2 â?¥ 94% on room air <br/ >6. Patients with SpO2 â?¥ 94% on two consecutive pulse-oximetric measurements performed at least two hours apart, on room air, when assessed prior to randomization. <br/ >7. Is willing and able to take oral medication <br/ >8. In case of female patients of child-bearing potential, a negative urine pregnancy test prior to beginning the therapy. <br/ >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. <br/ >As per latest Guidance documents updated periodically by Directorate General of Health Services, MoHFW, GOI <br/ >

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: <br/ >A) Peripheral Blood oxygen saturation < 94% <br/ >B) Respiratory Rate â?¥ 24 breaths per minute for adults and â?¥ 30 breaths per minute for patients aged 12 to <18 years. <br/ >C) Presence of shortness of breath (dyspnea) at rest, as a symptom <br/ >D) Grunting, severe retraction of chest, lethargy, somnolence and Seizure in patients aged 12 to <18 years <br/ >2. Patients with first onset of symptom(s) known to be associated with COVID-19 was >5 days prior to the day of randomization <br/ >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 <br/ >4. Patients with previous history of hypersensitivity or contra-indication to the IMP 2-deoxy-D-glucose or to the imaging marker fluorodeoxyglucose (FDG). <br/ >5. Patients with : <br/ >A) Presence of Uncontrolled diabetes mellitus <br/ >B) Presence or History of any Cardiac conduction disorders OR QTc interval >500 ms at baseline assessment <br/ >C) Presence of gastrointestinal disorder that could affect absorption of orally administered 2-DG solution <br/ >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 <br/ >6. Pregnant and Lactating patients. <br/ >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 <br/ >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 <br/ >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). <br/ >10. Patients with body weight <35 or > 105 kg. <br/ >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 <br/ >COVID-19 disease severity, as defined by â??Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI <br/ >

2

Dr Reddys Laboratories Limited

12

99

India

Mild disease at enrollment

1: Mild disease at enrollment

800

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

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

Phase 3

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