Abstract
The Exclusion of Patients with CKD in Prospectively Registered Interventional Trials for COVID-19-a Rapid Review of International Registry Data.
Highlights
189 (51.9%) of the clinical trials were classified by the investigators as “late-phase” (2b, 3, or 4) clinical trials
Pharmaceutical trials involving participants from China, those testing chloroquine/hydroxychloroquine, antivirals, and antibacterials, were more likely to exclude individuals with CKD, whereas those from Europe were less likely. These data suggest that patients with CKD are being excluded from almost half of all registered clinical trials for COVID-19
CKD COVID-19 Trials and a similar number of transplant recipients. This suggests that inclusivity of future COVID-19 trials in relation to CKD could be improved through more precise CKD definitions and consideration of medication appropriateness, perhaps with dose adjustments where applicable
Summary
We assessed inclusion and exclusion criteria of all registered interventional clinical trials for COVID-19 from data available on the World Health Organization International Clinical Trials Registry Platform[4] (WHO-ICTRP; data extracted April 22nd, 2020). Clinical trials were divided into “pharmaceutical” and “nonpharmaceutical” trials. The former was defined as any medication that would be regulated by the Food and Drug Administration or a similar regulatory body. Interventions and exclusion criteria for each trial were independently reviewed and extracted by two assessors blinded to other trial details. Pharmaceutical intervention suitability for patients with CKD was independently assessed by two blinded specialist renal pharmacists using summary of product characteristics (equivalent of United States prescribing information), British National Formulary[5] and the Renal Drug Database.[6] The study’s primary analysis considered trial exclusions for any type of nonend stage and end stage CKD.
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