2-Deoxy-D-Glucose as an Adjunct to Standard of Care in the Medical Management of COVID-19: A Proof-of-Concept & Dose-Ranging Randomised Clinical Trial
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Abstract
Objective
To evaluate the efficacy and safety of 2-deoxy-D-glucose (2-DG) in the treatment of COVID-19.
Participants
110 adults aged 18 to 65 years with moderate to severe COVID-19.
Interventions
63, 90, and 126 mg/kg/day 2-DG plus standard of care (SOC) versus SOC only.
Main Outcome Measures
Times to maintaining SpO 2 ≥94% on room air discharge, clinical recovery, vital signs normalisation, improvement by 1 and 2 points on WHO 10-point ordinal scale, negative conversion on RT-PCR, intensive care, and mortality.
Results
Patients treated with 90 mg/kg/day 2-DG plus SOC showed better outcomes. Time to maintaining SpO2 ≥94% was significantly shorter in the 2-DG 90 mg compared to SOC (median 2.5 days vs 5 days, Hazard ratio [95% confidence interval]=2.3 [1.14, 4.64], p =0.0201). Times to discharge from isolation ward, to clinical recovery, and to vital signs normalisation were significantly shorter for the 2-DG 90 mg group.
All three doses of 2-DG were well tolerated. Thirty-three (30.3%) patients reported 65 adverse events and were mostly (86%) mild.
Conclusion
2-DG 90 mg/kg/day as adjunct to SOC showed clinical benefits over SOC alone in the treatment of moderate to severe COVID-19. The promising trends observed in current phase-II study encourage confirmatory evaluation of the efficacy and safety of 2-DG in a larger phase-III trial.
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SciScore for 10.1101/2021.10.08.21258621: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial was conducted under the supervision of Drugs Controller General of India (DCGI) and approved by appropriate ethics committees (EC). Sex as a biological variable Participating Patients: The trial enrolled male or female patients aged 18 to 65 years, who were admitted to isolation wards at 12 COVID-19 management hospitals in India. Randomization This was a phase-II, multicentre, randomised, open-label, parallel-group clinical trial to evaluate the efficacy, safety, and tolerability of 2-DG administered adjunctly to standard of care (SOC), in comparison with SOC alone, in patients with moderate or severe COVID-19. Blinding not detected. Power Analysis There were no statistical power … SciScore for 10.1101/2021.10.08.21258621: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial was conducted under the supervision of Drugs Controller General of India (DCGI) and approved by appropriate ethics committees (EC). Sex as a biological variable Participating Patients: The trial enrolled male or female patients aged 18 to 65 years, who were admitted to isolation wards at 12 COVID-19 management hospitals in India. Randomization This was a phase-II, multicentre, randomised, open-label, parallel-group clinical trial to evaluate the efficacy, safety, and tolerability of 2-DG administered adjunctly to standard of care (SOC), in comparison with SOC alone, in patients with moderate or severe COVID-19. Blinding not detected. Power Analysis There were no statistical power calculations for sample size. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:A limitation of this phase 2 study is that it was not adequately powered. A subsequent adequately powered (80%) phase 3 clinical study has been initiated with prespecified primary and secondary endpoints. The results from the phase 3 study are expected to be published in the near future. For several patients in the current phase 2 study, a clinical status score of 4 (‘hospitalised, no oxygen therapy’) was recorded on the WHO 10-point ordinal scale at baseline, despite their requiring oxygen treatment. 21 out of 22 patients had SpO2 < 95% at baseline. Due to shortage of oxygen supply, many eligible patients did not receive oxygen supplementation in their respective hospitals. It is possible that these patients were assigned a score of 4 Another limitation was that meaningful comparison between the 2-DG groups and control groups on ICU admission and death was not possible due to small number of such events. In addition, the study was not placebo controlled or blinded.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a protocol registration statement.
Results from scite Reference Check: We found no unreliable references.
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