Evidence map›Paper›PMID 33752741›Full record

ArticleTrials2021

Post-exposure prophylaxis against SARS-CoV-2 in close contacts of confirmed COVID-19 cases (CORIPREV): study protocol for a cluster-randomized trial.

Darrell H S Tan, Adrienne K Chan, Peter Jüni, George Tomlinson, Nick Daneman, Sharon Walmsley, Matthew Muller, Rob Fowler, Srinivas Murthy, Natasha Press and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04321174 (COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 23% 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.

NCT04321174 phase3unknown statusnot on this map

COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir

TypeinterventionalSponsorUnity Health TorontoRan2020 to 2022Enrolled123ConditionsCoronavirus Infections, Post-exposure ProphylaxisArmsLopinavir/ritonavir
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. 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

14 authors at 8 institutions in 2 countries.

Darrell H S TanDivision of Infectious Diseases, St. Michael's Hospital, Toronto, Canada. darrell.tan@gmail.com.ORCID http://orcid.org/0000-0002-3069-2875
Adrienne K ChanDepartment of Medicine, University of Toronto, Toronto, Canada.
Peter JüniDepartment of Medicine, University of Toronto, Toronto, Canada.
George TomlinsonDepartment of Medicine, University Health Network, Toronto, Canada.
Nick DanemanDepartment of Medicine, University of Toronto, Toronto, Canada.
Sharon WalmsleyDepartment of Medicine, University of Toronto, Toronto, Canada.
Matthew MullerDivision of Infectious Diseases, St. Michael's Hospital, Toronto, Canada.
Rob FowlerDepartment of Medicine, University of Toronto, Toronto, Canada.
Srinivas MurthyDepartment of Pediatrics, University of British Columbia, Vancouver, Canada.
Natasha PressDivision of Infectious Diseases, St. Paul's Hospital, Vancouver, Canada.
Curtis CooperDivision of Infectious Diseases, Ottawa Hospital Research Institute, Ottawa, Canada.
Todd LeeDivision of Infectious Diseases, McGill University Health Centre, Montreal, Canada.
Tony MazzulliDepartment of Microbiology, Mount Sinai Hospital/University Health Network, Toronto, Canada.
Allison McGeerDepartment of Medicine, University of Toronto, Toronto, Canada.
St. Michael's Hospital · CAUniversity of Toronto · CAMount Sinai Hospital · CAUniversity Health Network · CAMcGill University Health Centre · CAOttawa Hospital · CASt. Paul's Hospital · CAUniversity of British Columbia · CA

Funding

CIHR OV4-170652 and VR4-172732
6 · The paper itself

Abstract

backgroundPost-exposure prophylaxis (PEP) is a well-established strategy for the prevention of infectious diseases, in which recently exposed people take a short course of medication to prevent infection. The primary objective of the COVID-19 Ring-based Prevention Trial with lopinavir/ritonavir (CORIPREV-LR) is to evaluate the efficacy of a 14-day course of oral lopinavir/ritonavir as PEP against COVID-19 among individuals with a high-risk exposure to a confirmed case.

methodsThis is an open-label, multicenter, 1:1 cluster-randomized trial of LPV/r 800/200 mg twice daily for 14 days (intervention arm) versus no intervention (control arm), using an adaptive approach to sample size calculation. Participants will be individuals aged > 6 months with a high-risk exposure to a confirmed COVID-19 case within the past 7 days. A combination of remote and in-person study visits at days 1, 7, 14, 35, and 90 includes comprehensive epidemiological, clinical, microbiologic, and serologic sampling. The primary outcome is microbiologically confirmed COVID-19 infection within 14 days after exposure, defined as a positive respiratory tract specimen for SARS-CoV-2 by polymerase chain reaction. Secondary outcomes include safety, symptomatic COVID-19, seropositivity, hospitalization, respiratory failure requiring ventilator support, mortality, psychological impact, and health-related quality of life. Additional analyses will examine the impact of LPV/r on these outcomes in the subset of participants who test positive for SARS-CoV-2 at baseline. To detect a relative risk reduction of 40% with 80% power at α = 0.05, assuming the secondary attack rate in ring members (p DISCUSSION: Harnessing safe, existing drugs such as LPV/r as PEP could provide an important tool for control of the COVID-19 pandemic. Novel aspects of our design include the ring-based prevention approach, and the incorporation of remote strategies for conducting study visits and biospecimen collection.

trial registrationThis trial was registered at www.ClinicalTrials.gov ( NCT04321174 ) on March 25, 2020.

Indexed as

Antiviral AgentsCOVID-19Drug CombinationsHospitalizationHumansLopinavirPost-Exposure ProphylaxisRandomized Controlled Trials as TopicRitonavirSARS-CoV-2Severity of Illness IndexTreatment OutcomeAntiviral AgentsDrug CombinationsLopinavirlopinavir-ritonavir drug combinationRitonavirChemoprophylaxisCluster randomizationCOVID-19Lopinavir/ritonavirPost-exposure prophylaxisProtocolRandomized controlled trial

Identifiers

PMID33752741
PMCPMC7982877
OpenAlexW3117434216

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.