Evidence map›Paper›PMID 38033705›Full record

ArticleJournal of clinical and translational science2023

Strategies used for the COVID-OUT decentralized trial of outpatient treatment of SARS-CoV-2.

Nandini Avula, Dustin Kakach, Christopher J Tignanelli, David M Liebovitz, Jacinda M Nicklas, Kenneth Cohen, Michael A Puskarich, Hrishikesh K Belani, John B Buse, Nichole R Klatt and 11 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Progress toward realizing the promise of decentralized clinical trials.Journal of clinical and translational science · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Nandini AvulaDepartment of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA.ORCID https://orcid.org/0000-0001-5323-2639
Dustin KakachInvestigational Drug Service, Fairview Health Services, University of Minnesota Medical Center, Minneapolis, MN, USA.
Christopher J TignanelliDepartment of Surgery, Medical School, University of Minnesota, Minneapolis, MN, USA.
David M LiebovitzDepartment of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Jacinda M NicklasDepartment of Medicine, School of Medicine, University of Colorado-Anschutz Medical Campus, Aurora, CO, USA.ORCID https://orcid.org/0000-0003-4418-5919
Kenneth CohenUnitedHealth Group, Optum Health, Minnetonka, MN, USA.
Michael A PuskarichDepartment of Emergency Medicine, School of Medicine, University of Minnesota, Minneapolis, MN, USA.
Hrishikesh K BelaniDepartment of Medicine, Olive View - University of California, Los Angeles, CA, USA.
John B BuseDepartment of Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.ORCID https://orcid.org/0000-0002-9723-3876
Nichole R KlattDepartment of Surgery, Medical School, University of Minnesota, Minneapolis, MN, USA.
Blake AndersonAtlanta Veterans Affairs Medical Center and the Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.
Amy B KargerDepartment of Laboratory Medicine and Pathology, Medical School, University of Minnesota, Minneapolis, MN, USA.
Katrina M HartmanDepartment of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA.
Barkha PatelDepartment of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA.
Sarah L FennoDepartment of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA.
Neha V ReddyDepartment of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA.ORCID https://orcid.org/0000-0001-5327-2876
Spencer M EricksonDepartment of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA.
David R BoulwareDepartment of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA.ORCID https://orcid.org/0000-0002-4715-0060
Thomas A MurrayDivision of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.
Carolyn T BramanteDepartment of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA.
COVID-OUT Trial Team

Funding

Pilot & Feasibility ProgramP30DK124723 · NIDDK · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Nicholette D. Allred · 2020 to 2026
$11.0M
Self-weighing for Weight Management in Adolescents with ObesityK23DK124654 · NIDDK · UNIVERSITY OF MINNESOTA · PI BRAMANTE, CAROLYN T · 2021 to 2024
$801k
NIDDK NIH HHS K23 DK124654NIDDK NIH HHS P30 DK124723
6 · The paper itself

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.

Indexed as

covidDecentralized clinical trialrandomized controlled trialremote researchtrial design

Identifiers

PMID38033705
PMCPMC10685265

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.