The Adaptive COVID-19 Treatment Trial-1 (ACTT-1) in a real-world population: a comparative observational study
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RESEARCH LETTER
Open Access
The Adaptive COVID‑19 Treatment Trial‑1 (ACTT‑1) in a real‑world population: a comparative observational study Matilde Tejlbo Frost1, Espen Jimenez‑Solem1,2,3, Mikkel Zöllner Ankarfeldt3,4, Martin Erik Nyeland1, Anne Helms Andreasen4 and Tonny Studsgaard Petersen1,2*
Background The recently published ‘Adaptive COVID-19 Treatment Trial’ (ACTT-1) showed that remdesivir is a promising treatment option against coronavirus disease 2019 (COVID-19) [1]. Consequently, remdesivir is now being evaluated for implementation in clinical practice worldwide. Randomized clinical trials (RCTs) are the current golden standard for procuring evidence of a drug’s efficacy, but in order to predict effectiveness and safety in daily clinical practice, it is important to complement the results from RCTs with an evaluation of their transferability to a real-world setting. To bridge the evidentiary gap between clinical research and clinical practice, the U.S. Food and Drug Administration recognizes the need for harnessing ‘Real-World Data’ and observational methods to generate evidence of effectiveness to support regulatory decisions concerning drugs [2]. Objective The aim of the present study was to examine whether the evidence generated in the ACTT-1 could be applied to a real-world population by comparing characteristics of the included patients and their outcomes in order to evaluate *Correspondence: [email protected] 1 Department of Clinical Pharmacology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, indgang 20 C, 2. sal, 2400 Copenhagen, NV, Denmark Full list of author information is available at the end of the article
the transferability of the trial’s outcomes to the patients eligible for remdesivir treatment in clinical practice.
Methods and findings Data for the present study were extracted from hospital electronic health records of all patients with a positive severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) test in the Capital Region of Denmark admitted to a hospital between March 1 and May 5, 2020. Patients’ eligibility was assessed using inclusion and exclusion criteria from ACCT-1. Index time for baseline characteristics and start of follow-up was defined as 24 h after admission or time of first positive SARS-CoV-2 test result, whichever came last based on an assumption that most patients would have been included in the ACCT-1 trial prior to this timepoint. We assessed mortality and time to discharge as a comparable outcome to time to recovery in ACCT-1, during the first 29 days. Indirect standardization was used to weight the cohort to the same eight-point ordinal severity baseline score as the placebo group in the ACTT-1. We identified 1053 patients admitted with COVID-19. Four hundred and seventy-four patients were ineligible according to inclusion criteria (385 due to mild disease) and exclusion criteria (84 due to severe chronic kidney disease). The remaining 579 patients had complete follow-up. Compared to the pla
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