Evidence map›Paper›PMID 33274479›Full record

Trial reportJournal of internal medicine2021

Cyclosporine A plus low-dose steroid treatment in COVID-19 improves clinical outcomes in patients with moderate to severe disease: A pilot study.

J L Gálvez-Romero, O Palmeros-Rojas, F A Real-Ramírez, S Sánchez-Romero, R Tome-Maxil, M P Ramírez-Sandoval, R Olivos-Rodríguez, S E Flores-Encarnación, A A Cabrera-Estrada, J Ávila-Morales and 14 more

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Journal of internal medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 5 pooled it
1.2field-weighted citation impact, top 12% 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

36 citing papers in PubMed, 5 syntheses or guidelines pooled it, 52 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 3 institutions in 1 country.

J L Gálvez-RomeroFrom the, Departamento de investigación, Hospital Regional, ISSSTE, Puebla, México.ORCID 0000-0002-6560-3596
O Palmeros-RojasÁrea de Matemáticas, Departamento de Preparatoria Agrícola, Universidad Autónoma Chapingo, Texcoco, México.ORCID 0000-0001-8952-6372
F A Real-RamírezDepartamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.
S Sánchez-RomeroDepartamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.
R Tome-MaxilDepartamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.
M P Ramírez-SandovalDepartamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.
R Olivos-RodríguezDepartamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.
S E Flores-EncarnaciónDepartamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.
A A Cabrera-EstradaDepartamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.
J Ávila-MoralesDepartamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.
V Cortés-SánchezDepartamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.
G Sarmiento-PadillaDepartamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.
S E Tezmol-RamírezDepartamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.
D Aparicio-HernándezDepartamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.
M I Urbina-SánchezDepartamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.
M Á Gómez-PlumaDepartamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.
S Cisneros-MéndezDepartamento de Medicina Interna, Hospital Regional, ISSSTE, Puebla, México.
D I Rodríguez-RivasDepartamento de Radiología, Hospital Regional, ISSSTE, Puebla, México.
S Reyes-InurrigarroDepartamento del Servicio de Urgencias y Terapia Intensiva, Hospital Regional, ISSSTE, Puebla, México.
G Cortés-DíazDepartamento del Servicio de Urgencias y Terapia Intensiva, Hospital Regional, ISSSTE, Puebla, México.
C Cruz-DelgadoDepartamento del Servicio de Urgencias y Terapia Intensiva, Hospital Regional, ISSSTE, Puebla, México.
J Navarro-GonzálezDepartamento del Servicio de Epidemiología, Hospital Regional, ISSSTE, Puebla, México.
J Deveaux-HomsDirector Médico, Hospital Regional, Hospital Regional ISSSTE, Puebla, México.
S Pedraza-SánchezUnidad de Bioquímica, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ), and Facultad de Ciencias, Universidad Nacional Autónoma de México (UNAM), Ciudad de México, México.ORCID 0000-0002-7062-6979
Institute for Social Security and Services for State Workers · MXChapingo Autonomous University · MXInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCOVID-19 pandemic causes high global morbidity and mortality and better medical treatments to reduce mortality are needed.

objectiveTo determine the added benefit of cyclosporine A (CsA), to low-dose steroid treatment, in patients with COVID-19.

methodsOpen-label, non randomized pilot study of patients with confirmed infection of SARS-CoV-2 hospitalized from April to May 2020 at a single centre in Puebla, Mexico. Patients were assigned to receive either steroids or CsA plus steroids. Pneumonia severity was assessed by clinical, laboratory, and lung tomography. The death rate was evaluated at 28 days.

resultsA total of 209 adult patients were studied, 105 received CsA plus steroids (age 55.3 ± 13.3; 69% men), and 104 steroids alone (age 54.06 ± 13.8; 61% men). All patients received clarithromycin, enoxaparin and methylprednisolone or prednisone up to 10 days. Patient's death was associated with hypertension (RR = 3.5) and diabetes (RR = 2.3). Mortality was 22 and 35% for CsA and control groups (P = 0.02), respectively, for all patients, and 24 and 48.5% for patients with moderate to severe disease (P = 0.001). Higher cumulative clinical improvement was seen for the CsA group (Nelson Aalen curve, P = 0.001, log-rank test) in moderate to severe patients. The Cox proportional hazard analysis showed the highest HR improvement value of 2.15 (1.39-3.34, 95%CI, P = 0.0005) for CsA treatment in moderate to severe patients, and HR = 1.95 (1.35-2.83, 95%CI, P = 0.0003) for all patients.

conclusionCsA used as an adjuvant to steroid treatment for COVID-19 patients showed to improve outcomes and reduce mortality, mainly in those with moderate to severe disease. Further investigation through controlled clinical trials is warranted.

Indexed as

COVID-19 Drug TreatmentCOVID-19CyclosporineDrug Therapy, CombinationFemaleGlucocorticoidsHumansLungMaleMethylprednisoloneMiddle AgedPilot ProjectsPrednisoneTreatment OutcomeCyclosporineGlucocorticoidsMethylprednisolonePrednisoneCOVID-19cyclosporine Aimprovementmortalitypneumoniasteroids

Identifiers

PMID33274479
PMCPMC7753398
OpenAlexW3107287672

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.