دورية أكاديمية
Strategies used for the COVID-OUT decentralized trial of outpatient treatment of SARS-CoV-2.
| العنوان: | Strategies used for the COVID-OUT decentralized trial of outpatient treatment of SARS-CoV-2. |
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| المؤلفون: | Avula, Nandini, Kakach, Dustin, Tignanelli, Christopher J, Liebovitz, David M, Nicklas, Jacinda M, Cohen, Kenneth, Puskarich, Michael A, Belani, Hrishikesh K, Buse, John B, Klatt, Nichole R, Anderson, Blake, Karger, Amy B, Hartman, Katrina M, Patel, Barkha, Fenno, Sarah L, Reddy, Neha V, Erickson, Spencer M, Boulware, David R, Murray, Thomas A, Bramante, Carolyn T |
| المصدر: | J Clin Transl Sci ; ISSN:2059-8661 ; Volume:7 ; Issue:1 |
| بيانات النشر: | PubMed Central |
| سنة النشر: | 2023 |
| المجموعة: | PubMed Central (PMC) |
| مصطلحات موضوعية: | Decentralized clinical trial, covid, randomized controlled trial, remote research, trial design |
| الوصف: | The COVID-19 pandemic accelerated the development of decentralized clinical trials (DCT). DCT's are an important and pragmatic method for assessing health outcomes yet comprise only a minority of clinical trials, and few published methodologies exist. In this report, we detail the operational components of COVID-OUT, a decentralized, multicenter, quadruple-blinded, randomized trial that rapidly delivered study drugs nation-wide. The trial examined three medications (metformin, ivermectin, and fluvoxamine) as outpatient treatment of SARS-CoV-2 for their effectiveness in preventing severe or long COVID-19. Decentralized strategies included HIPAA-compliant electronic screening and consenting, prepacking investigational product to accelerate delivery after randomization, and remotely confirming participant-reported outcomes. Of the 1417 individuals with the intention-to-treat sample, the remote nature of the study caused an additional 94 participants to not take any doses of study drug. Therefore, 1323 participants were in the modified intention-to-treat sample, which was the a priori primary study sample. Only 1.4% of participants were lost to follow-up. Decentralized strategies facilitated the successful completion of the COVID-OUT trial without any in-person contact by expediting intervention delivery, expanding trial access geographically, limiting contagion exposure, and making it easy for participants to complete follow-up visits. Remotely completed consent and follow-up facilitated enrollment. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | https://doi.org/10.1017/cts.2023.668Test; https://pubmed.ncbi.nlm.nih.gov/38033705Test; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10685265Test/ |
| DOI: | 10.1017/cts.2023.668 |
| الإتاحة: | https://doi.org/10.1017/cts.2023.668Test https://pubmed.ncbi.nlm.nih.gov/38033705Test https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10685265Test/ |
| حقوق: | © The Author(s) 2023. |
| رقم الانضمام: | edsbas.DC4113B4 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1017/cts.2023.668 |
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