Evidence map›Paper›PMID 35379296›Full record

Trial reportTrials2022

Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate to severe ARDS in a randomized, placebo-controlled, double-blind trial: preliminary evaluation of safety and feasibility in light of the COVID-19 pandemic.

Benedikt Schmid, Peter Kranke, Rudolf Lucas, Patrick Meybohm, Bernhard Zwissler, Sandra Frank

Open access · goldAbstract readLetterRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 26% 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.

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

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
  5. The Epithelial Sodium Channel-An Underestimated Drug Target.International journal of molecular sciences · 2023
    Review
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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

6 authors at 4 institutions in 2 countries.

Benedikt SchmidDepartment of Anesthesiology, Critical Care, Emergency and Pain Medicine, Wuerzburg University Hospital, Wuerzburg, Germany.
Peter KrankeDepartment of Anesthesiology, Critical Care, Emergency and Pain Medicine, Wuerzburg University Hospital, Wuerzburg, Germany. kranke_p@ukw.de.ORCID http://orcid.org/0000-0001-5324-981X
Rudolf LucasVascular Biology Center, Department of Pharmacology and Toxicology and Division of Pulmonary and Critical Care Medicine, Medical College of Georgia at Augusta University, Augusta, GA, 30912, USA.
Patrick MeybohmDepartment of Anesthesiology, Critical Care, Emergency and Pain Medicine, Wuerzburg University Hospital, Wuerzburg, Germany.
Bernhard ZwisslerDepartment of Anesthesiology, Ludwig Maximilian University Hospital, Munich, Germany.
Sandra FrankDepartment of Anesthesiology, Ludwig Maximilian University Hospital, Munich, Germany.
Universitätsklinikum Würzburg · DEAugusta University · USGerman Center for Lung Research · DELudwig-Maximilians-Universität München · DE

Funding

Horizon 2020 101003595Österreichische Forschungsförderungsgesellschaft 880862
6 · The paper itself

Abstract

backgroundIn May 2018, the first patient was enrolled in the phase-IIb clinical trial "Safety and Preliminary Efficacy of Sequential Multiple Ascending Doses of Solnatide to Treat Pulmonary Permeability Edema in Patients with Moderate to Severe ARDS." With the onset of the COVID-19 pandemic in early 2020, the continuation and successful execution of this clinical study was in danger. Therefore, before the Data Safety Monitoring Board (DSMB) allowed proceeding with the study and enrollment of further COVID-19 ARDS patients into it, additional assessment on possible study bias was considered mandatory.

methodsWe conducted an ad hoc interim analysis of 16 patients (5 COVID-19- ARDS patients and 11 with ARDS from different causes) from the phase-IIB clinical trial. We assessed possible differences in clinical characteristics of the ARDS patients and the impact of the pandemic on study execution.

resultsCOVID-19 patients seemed to be less sick at baseline, which also showed in higher survival rates over the 28-day observation period. Trial specific outcomes regarding pulmonary edema and ventilation parameters did not differ between the groups, nor did more general indicators of (pulmonary) sepsis like oxygenation ratio and required noradrenaline doses.

conclusionThe DSMB and the investigators did not find any evidence that patients suffering from ARDS due to SARS-CoV-2 may be at higher (or generally altered) risk when included in the trial, nor were there indications that those patients might influence the integrity of the study data altogether. For this reason, a continuation of the phase IIB clinical study activities can be justified. Researchers continuing clinical trials during the pandemic should always be aware that the exceptional circumstances may alter study results and therefore adaptations of the study design might be necessary.

Indexed as

COVID-19Pulmonary EdemaRespiratory Distress SyndromeDouble-Blind MethodEdemaFeasibility StudiesHumansPandemicsPeptides, CyclicPermeabilitySARS-CoV-2AP301 peptidePeptides, Cyclic

Identifiers

PMID35379296
PMCPMC8978157
OpenAlexW4225869357

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Registered trials

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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.