Table 4.
Planned and ongoing randomized controlled trials with anti-diabetic agents in COVID-1973−77.
| Anti-diabetic drugs vs. Comparators | Study title (NCT number) | N | Place | Primary outcome (Time frame) | Secondary outcome (Time frame) | Estimated completion; Status at the time of writing |
|---|---|---|---|---|---|---|
| Metformin | ||||||
| Metformin vs. Placebo | MET-Covid Trial: Metformin for Outpatient Treatment and Post-exposure Prophylaxis of COVID-19 (NCT04510194) | 70 | University of Minnesota, USA | i. Change in CRP ii. Change in albumin iii. Change in viral load (Time frame 10 days) |
i. Emergency department utilization ii. Incidence of possible COVID-19 symptoms iii. WHO disease progression scale (Time frame 14–28 days) |
September 2021; not yet recruiting |
| DPP-4 inhibitors | ||||||
| Sitagliptin vs. Placebo (with or without insulin) | SIDIACO: The Effect of Sitagliptin Treatment in COVID-19 Positive Diabetic Patients (NCT04365517) | 170 | University of Milan, Italy | i. Time of clinical improvement ii. Clinical parameter of acute lung disease iii. Biochemical parameter of acute lung disease (Time frame 1 month) |
i. Cytokine-inflammatory profile (Time frame 6 month) | December 2021; not yet recruiting |
| Linagliptin vs. Placebo in background insulin therapy (Hospital setting) | Effects of DPP-4 inhibition on COVID-19 (NCT04341935) | 20 | University of Miami, USA | i. Changes in glucose level (Time frame 14 days) | i. Changes in SpO2 levels ii. Changes in IL-6 iii. Changes in chest radiography (Time frame 14 days) |
December 2021; not yet recruiting |
| Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19 (NCT04371978) | 100 | Rabin Medical Center, Israel | i. Time to clinical changes in 8-point WHO Ordinal scale (Time frame 28 days) | i. Clinical improvement ii. Length of hospitalization iii. All-cause mortality iv. Mechanical ventilation use v. ICU admissions vi. Virological response (Time frame 28 days) |
September 2021; recruiting | |
| SGLT-2 inhibitors | ||||||
| Dapagliflozin vs. Placebo | DARE-19: Dapagliflozin in Respiratory Failure in Patients With COVID-19 (NCT04350593) | 900 | Saint Lukes’ Health System, USA | Time to first occurrence of death due to any cause or anyone new/worsened organ dysfunction – i. Mechanical ventilation ii. New or worsening HF iii. Vasopressor therapy iv. VT/VF v. Initiation of RRT (Time frame 30 days) |
i. Composite outcome (all-cause death, new/worsening organ dysfunction, clinical status at day 30, time to discharge) ii. Time to hospital discharge iii. Time to death iv. Time to new/worsened organ dysfunction v. Time to acute kidney injury (Time frame 30 days) |
December 2020, recruiting |
HF- heart failure, VT- Ventricular tachycardia, VF- Ventricular fibrillation, RRT- Renal replacement therapy, SpO2- Oxygen saturation, IL-6- Interleukin-6, ICU- Intensive care unit.