{"doi":"10.1017/cts.2023.668","title":"Strategies used for the COVID-OUT decentralized trial of outpatient treatment of SARS-CoV-2","abstract":"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.","journal":"Journal of Clinical and Translational Science","year":2023,"id":377942,"datarank":0.20794415416798362,"base_score":1.3862943611198906,"endowment":1.3862943611198906,"self_citation_contribution":0.20794415416798362,"citation_network_contribution":0.0,"self_endowment_contribution":0.20794415416798362,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":3,"citer_count":1,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9476,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1141883,"name":"Dustin Kakach","orcid":null,"position":1,"is_corresponding":false},{"id":437905,"name":"Christopher J. Tignanelli","orcid":"0000-0002-8079-5565","position":2,"is_corresponding":false},{"id":488212,"name":"David Liebovitz","orcid":"0000-0002-2518-5940","position":3,"is_corresponding":false},{"id":502706,"name":"Jacinda M. Nicklas","orcid":"0000-0003-4418-5919","position":4,"is_corresponding":false},{"id":661299,"name":"Ken Cohen","orcid":"0000-0002-6141-9142","position":5,"is_corresponding":false},{"id":321110,"name":"Michael A. Puskarich","orcid":"0000-0001-6358-4670","position":6,"is_corresponding":false},{"id":891992,"name":"Hrishikesh Belani","orcid":"0000-0003-1259-155X","position":7,"is_corresponding":false},{"id":34495,"name":"John B. Buse","orcid":"0000-0002-9723-3876","position":8,"is_corresponding":false},{"id":332551,"name":"Nichole R. Klatt","orcid":"0000-0003-2968-5480","position":9,"is_corresponding":false},{"id":1014981,"name":"Blake Anderson","orcid":"0000-0003-3237-9046","position":10,"is_corresponding":false},{"id":231205,"name":"Amy B. Karger","orcid":"0000-0002-2781-3824","position":11,"is_corresponding":false},{"id":891990,"name":"Katrina M Hartman","orcid":"0000-0001-6723-0423","position":12,"is_corresponding":false},{"id":983827,"name":"Barkha Patel","orcid":null,"position":13,"is_corresponding":false},{"id":983826,"name":"Sarah L. Fenno","orcid":null,"position":14,"is_corresponding":false},{"id":994233,"name":"Neha V Reddy","orcid":"0000-0001-5327-2876","position":15,"is_corresponding":false},{"id":983286,"name":"Spencer M Erickson","orcid":"0000-0003-0220-4712","position":16,"is_corresponding":false},{"id":267658,"name":"David R. Boulware","orcid":"0000-0002-4715-0060","position":17,"is_corresponding":false},{"id":387536,"name":"Thomas A. Murray","orcid":"0000-0003-2769-4957","position":18,"is_corresponding":false},{"id":49889,"name":"Carolyn T. 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