Evidence map›Paper›PMID 38490660›Full record

Trial reportBMJ open2024

Multicentre, randomised, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of acute respiratory distress syndrome and acute kidney injury in patients infected with SARS-CoV-2 (COVID-19).

Ranjani Somayaji, David R Luke, Arthur Lau, Rahmet Guner, Ŏ Fehmi Tabak, Mark Hepokoski, Nancy Gardetto, Steven A Conrad, Sunil D Kumar, Kalyan Ghosh and 9 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04402957 (Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of LSALT Peptide as Prevention of Acute Respiratory Distress Syndrome), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 24% 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.

NCT04402957 phase2completednot on this map

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of LSALT Peptide as Prevention of Acute Respiratory Distress Syndrome (ARDS) and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)

TypeinterventionalSponsorArch Biopartners Inc.Ran2020 to 2022Enrolled61ConditionsCOVID, Severe Acute Respiratory Syndrome, Sars-CoV2, Acute Kidney InjuryArmsLSALT peptide, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Peptide-Based Vaccines and Therapeutics for COVID-19.International journal of peptide research and therapeutics · 2022
    Review
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

19 authors at 6 institutions in 3 countries.

Ranjani SomayajiDepartment of Medicine, University of Calgary, Calgary, Alberta, Canada rsomayaj@ucalgary.ca.ORCID 0000-0003-3731-9675
David R LukeArch Biopartners Inc, Toronto, Ontario, Canada.
Arthur LauDepartment of Medicine, University of Calgary, Calgary, Alberta, Canada.
Rahmet GunerIstanbul University-Cerrahpasa School of Medicine, Ankara, Turkey.
Ŏ Fehmi TabakIstanbul University-Cerrahpasa School of Medicine, Ankara, Turkey.
Mark HepokoskiUniversity of California San Diego Medical Center, San Diego, California, USA.
Nancy GardettoUniversity of California San Diego Medical Center, San Diego, California, USA.
Steven A ConradDepartments of Medicine, Pediatrics, and Emergency Medicine, Louisiana State University Health Sciences Center, Shreveport, Louisiana, USA.ORCID 0000-0002-4014-969X
Sunil D KumarBroward Health Medical Center, Ft. Lauderdale, Florida, USA.
Kalyan GhoshInference Inc, Chesterbrook, Pennsylvania, USA.
Stephen M RobbinsDepartment of Oncology, University of Calgary, Calgary, Alberta, Canada.
Donna L SengerDepartment of Oncology, University of Calgary, Calgary, Alberta, Canada.
Daisy SunArch Biopartners Inc, Toronto, Ontario, Canada.
Rachel K S LimDepartment of Medicine, University of Calgary, Calgary, Alberta, Canada.
Jonathan LiuDepartment of Medicine, University of Calgary, Calgary, Alberta, Canada.
Fatma EserDepartments of Medicine, Infectious Diseases and Clinical Microbiology - Ankara City Hospital, Ankara Yildirim Beyazit University, Ankara, Turkey.ORCID 0000-0002-0282-6346
Ridvan KaraaliIstanbul University-Cerrahpasa School of Medicine, Ankara, Turkey.
Alain TremblayDepartment of Medicine, University of Calgary, Calgary, Alberta, Canada.
Daniel MuruveDepartment of Medicine, University of Calgary, Calgary, Alberta, Canada.ORCID 0000-0003-1757-218X
University of Calgary · CAIstanbul University-Cerrahpaşa · TRVA San Diego Healthcare System · USAnkara Yıldırım Beyazıt University · TRBroward Health Medical Center · USLouisiana State University Health Sciences Center Shreveport · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveDipeptidase-1 (DPEP-1) is a recently discovered leucocyte adhesion receptor for neutrophils and monocytes in the lungs and kidneys and serves as a potential therapeutic target to attenuate inflammation in moderate-to-severe COVID-19. We aimed to evaluate the safety and efficacy of the DPEP-1 inhibitor, LSALT peptide, to prevent specific organ dysfunction in patients hospitalised with COVID-19.

designPhase 2a randomised, placebo-controlled, double-blinded, trial.

settingHospitals in Canada, Turkey and the USA.

participantsA total of 61 subjects with moderate-to-severe COVID-19.

interventionsRandomisation to LSALT peptide 5 mg intravenously daily or placebo for up to 14 days. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoint was the proportion of subjects alive and free of respiratory failure and/or the need for renal replacement therapy (RRT). Numerous secondary and exploratory endpoints were assessed including ventilation-free days, and changes in kidney function or serum biomarkers.

resultsAt 28 days, 27 (90.3%) and 28 (93.3%) of subjects in the placebo and LSALT groups were free of respiratory failure and the need for RRT (p=0.86). On days 14 and 28, the number of patients still requiring more intensive respiratory support (O

conclusionIn a Phase 2 study, LSALT peptide was demonstrated to be safe and tolerated in patients hospitalised with moderate-to-severe COVID-19. TRIAL REGISTRATION NUMBER: NCT04402957.

Indexed as

Acute Kidney InjuryCOVID-19Respiratory Distress SyndromeRespiratory InsufficiencyDouble-Blind MethodHumansProof of Concept StudySARS-CoV-2Treatment OutcomeClinical TrialCOVID-19INFECTIOUS DISEASESSafety

Identifiers

PMID38490660
PMCPMC10946381
OpenAlexW4394738358

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.