Evidence map›Paper›PMID 35395957›Full record

ArticleTrials2022

Trial of Early Antiviral Therapies during Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19: a summary of the protocol and analysis plan for a decentralized randomized controlled trial.

Alexander M Kaizer, Jessica Wild, Christopher J Lindsell, Todd W Rice, Wesley H Self, Samuel Brown, B Taylor Thompson, Kimberly W Hart, Clay Smith, Michael S Pulia and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04372628 (Trial of Early Therapies During Non-hospitalized Outpatient Window), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.7field-weighted citation impact, top 31% of its field
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.

NCT04372628 phase2completednot on this map

Trial of Early Therapies During Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19

TypeinterventionalSponsorVanderbilt University Medical CenterRan2020 to 2022Enrolled452ConditionsCOVID-19ArmsLopinavir/Ritonavir 400 mg/100 mg, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Lopinavir/ritonavir for treatment of non-hospitalized patients with COVID-19: a randomized clinical trial.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2023
    Trial
  2. Article
  3. Article
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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

12 authors at 8 institutions in 1 country.

Alexander M KaizerDepartment of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado, Aurora, USA. ALEX.KAIZER@CUANSCHUTZ.EDU.ORCID http://orcid.org/0000-0003-2334-5514
Jessica WildDepartment of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado, Aurora, USA.
Christopher J LindsellDepartment of Biostatistics, Vanderbilt University, Nashville, USA.
Todd W RiceDivision of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, USA.
Wesley H SelfDepartment of Emergency Medicine and Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, USA.
Samuel BrownDivision of Pulmonary and Critical Care Medicine, Department of Medicine, Intermountain Medical Center, Salt Lake City, USA.
B Taylor ThompsonDivision of Pulmonary and Critical Care Medicine, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, USA.
Kimberly W HartDepartment of Biostatistics, Vanderbilt University, Nashville, USA.
Clay SmithDepartment of Emergency Medicine, Vanderbilt University Medical Center, Nashville, USA.
Michael S PuliaDepartments of Emergency Medicine and Industrial and Systems Engineering, University of Wisconsin-Madison, Madison, USA.
Nathan I ShapiroDepartment of Emergency Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, USA.
Adit A GindeDepartment of Emergency Medicine, University of Colorado School of Medicine, Aurora, USA.
Vanderbilt University Medical Center · USColorado School of Public Health · USVanderbilt University · USBeth Israel Deaconess Medical Center · USHarvard University · USUniversity of Colorado Denver · USUniversity of Utah · USUniversity of Wisconsin–Madison · US

Funding

Statistical Methods and Adaptive Trial Designs for Cardiovascular Outcomes with Information SharingK01HL151754 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI KAIZER, ALEXANDER MARK · 2021 to 2025
$742k
NHLBI NIH HHS K01 HL151754U.S. Department of Defense ID07200010-301-2
6 · The paper itself

Abstract

backgroundCoronavirus disease 2019 (COVID-19) has a heterogeneous outcome in individuals from remaining asymptomatic to death. In a majority of cases, mild symptoms are present that do not require hospitalization and can be successfully treated in the outpatient setting, though symptoms may persist for a long duration. We hypothesize that drugs suitable for decentralized study in outpatients will have efficacy among infected outpatients

methodsThe TREAT NOW platform is designed to accommodate testing multiple agents with the ability to incorporate new agents in the future. TREAT NOW is an adaptive, blinded, multi-center, placebo-controlled superiority randomized clinical trial which started with two active therapies (hydroxychloroquine and lopinavir/ritonavir) and placebo, with the hydroxychloroquine arm dropped shortly after enrollment began due to external evidence. Each arm has a target enrollment of 300 participants who will be randomly assigned in an equal allocation to receive either an active therapy or placebo twice daily for 14 days with daily electronic surveys collected over days 1 through 16 and on day 29 to evaluate symptoms and a modified COVID-19 ordinal outcome scale. Participants are enrolled remotely by telephone and consented with a digital interface, study drug is overnight mailed to study participants, and data collection occurs electronically without in-person interactions. DISCUSSION: If effective treatments for COVID-19 can be identified for individuals in the outpatient setting before they advance to severe disease, it will prevent progression to more severe disease, reduce the need for hospitalization, and shorten the duration of symptoms. The novel decentralized, "no touch" approach used by the TREAT NOW platform has distinction advantages over traditional in-person trials to reach broader populations and perform study procedures in a pragmatic yet rigorous manner.

trial registrationClinicalTrials.gov NCT04372628. Registered on April 30, 2020. First posted on May 4, 2020.

Indexed as

Antiviral AgentsCOVID-19 Drug TreatmentHydroxychloroquineAdaptive Clinical Trials as TopicEquivalence Trials as TopicHospitalizationHumansMulticenter Studies as TopicOutpatientsPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicTreatment OutcomeAntiviral AgentsHydroxychloroquineAntiviralCOVID-19OutpatientProtocolRandomizedRemote

Identifiers

PMID35395957
PMCPMC8990452
OpenAlexW4223595569

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.