Evidence map›Paper›PMID 35395943›Full record

Trial reportCritical care (London, England)2022

Auxora vs. placebo for the treatment of patients with severe COVID-19 pneumonia: a randomized-controlled clinical trial.

Charles Bruen, Mukhtar Al-Saadi, Edward A Michelson, Maged Tanios, Raul Mendoza-Ayala, Joseph Miller, Jeffrey Zhang, Kenneth Stauderman, Sudarshan Hebbar, Peter C Hou

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Critical care (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04345614 (Part 1), which is not on this map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
3.6field-weighted citation impact, top 5% 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.

NCT04345614 phase2completednot on this map

Part 1: A Randomized Controlled Open-Label Study of CM4620 Injectable Emulsion (CM4620-IE) in Patients With Severe COVID-19 Pneumonia Part 2: A Randomized Double Blind, Placebo-Controlled Study of Auxora for the Treatment of Severe COVID-19 Pneumonia (CARDEA)

TypeinterventionalSponsorCalciMedica, Inc.Ran2020 to 2021Enrolled314ConditionsPneumoniaArmsAuxora (Part 1), Standard of Care (Part 1), Auxora (Part 2), Placebo (Part 2)
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 40 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. CRAC channels as targets for immunotherapy.Current opinion in immunology · 2026
    Review
  6. Orai1 is required for CabioRxiv : the preprint server for biology · 2026
    Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Contemporary Approach to Acute Pancreatitis in Emergency Medicine.Journal of the American College of Emergency Physicians open · 2025
    Review
  14. STIM1 and lipid interactions at ER-PM contact sites.American journal of physiology. Cell physiology · 2025
    Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. 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

10 authors at 9 institutions in 1 country.

Charles Bruen *Regions Hospital, Health Partners, St. Paul, MN, USA.
Mukhtar Al-Saadi *Houston Methodist Hospital, Houston, TX, USA.
Edward A MichelsonDepartment of Emergency Medicine, Texas Tech University Health Sciences Center, El Paso, TX, USA.
Maged TaniosMemorialCare Long Beach Medical Center, Long Beach, CA, USA.
Raul Mendoza-AyalaAurora BayCare Medical Center, Green Bay, WI, USA.
Joseph MillerHenry Ford Hospital System, Detroit, MI, USA.
Jeffrey ZhangPrinceton Pharmatech, Princeton, NJ, USA.
Kenneth StaudermanCalciMedica, Inc, 505 Coast Blvd. South Suite 307, La Jolla, CA, 92037, USA.
Sudarshan HebbarCalciMedica, Inc, 505 Coast Blvd. South Suite 307, La Jolla, CA, 92037, USA. sudarshan@calcimedica.com.
Peter C Hou *Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
CalciMedica (United States) · USAurora BayCare Medical Center · USHarvard University · USHealthPartners · USHenry Ford Hospital · USLong Beach Medical Center · USMethodist Hospital · USPrinceton BioMeditech (United States) · USTexas Tech University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCalcium release-activated calcium (CRAC) channel inhibitors block proinflammatory cytokine release, preserve endothelial integrity and may effectively treat patients with severe COVID-19 pneumonia.

methodsCARDEA was a phase 2, randomized, double-blind, placebo-controlled trial evaluating the addition of Auxora, a CRAC channel inhibitor, to corticosteroids and standard of care in adults with severe COVID-19 pneumonia. Eligible patients were adults with ≥ 1 symptom consistent with COVID-19 infection, a diagnosis of COVID-19 confirmed by laboratory testing using polymerase chain reaction or other assay, and pneumonia documented by chest imaging. Patients were also required to be receiving oxygen therapy using either a high flow or low flow nasal cannula at the time of enrolment and have at the time of enrollment a baseline imputed PaO

resultsThe pre-specified efficacy set consisted of the 261 patients with a baseline imputed PaO

conclusionsAuxora was safe and well tolerated with strong signals in both time to recovery and all-cause mortality through Day 60 in patients with severe COVID-19 pneumonia. Further studies of Auxora in patients with severe COVID-19 pneumonia are warranted. Trial registration NCT04345614.

Indexed as

BenzamidesCalcium Release Activated Calcium ChannelsCOVID-19 Drug TreatmentPyrazinesRespiratory Distress SyndromeAdultHumansRespiration, ArtificialSARS-CoV-2Treatment OutcomeBenzamidesCalcium Release Activated Calcium ChannelsPyrazineszegocractin

Identifiers

PMID35395943
PMCPMC8992417
OpenAlexW4223615942

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.