Evidence map›Paper›PMID 35599154›Full record

Trial reportJournal of internal medicine2022

Randomized clinical trial of BCG vaccine in patients with convalescent COVID-19: Clinical evolution, adverse events, and humoral immune response.

Mehrsa Jalalizadeh, Keini Buosi, Franciele A V Dionato, Luciana S B Dal Col, Cristiane F Giacomelli, Karen L Ferrari, Ana Carolina Pagliarone, Patrícia A F Leme, Cristiane L Maia, Reza Yadollahvandmiandoab and 4 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of internal medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04369794 (COVID-19), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 15% 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.

NCT04369794 phase4completednot on this map

COVID-19: BCG As Therapeutic Vaccine, Transmission Limitation, and Immunoglobulin Enhancement

TypeinterventionalSponsorUniversity of Campinas, BrazilRan2020 to 2023Enrolled400ConditionsCOVID-19, Therapeutic Vaccine, BCG, SARS-CoV 2ArmsBCG, Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

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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

14 authors at 3 institutions in 2 countries.

Mehrsa JalalizadehDepartment of UroScience, School of Medical Sciences, State University of Campinas-UNICAMP, Campinas, Brazil.
Keini BuosiDepartment of UroScience, School of Medical Sciences, State University of Campinas-UNICAMP, Campinas, Brazil.
Franciele A V DionatoDepartment of UroScience, School of Medical Sciences, State University of Campinas-UNICAMP, Campinas, Brazil.
Luciana S B Dal ColDepartment of UroScience, School of Medical Sciences, State University of Campinas-UNICAMP, Campinas, Brazil.
Cristiane F GiacomelliDepartment of UroScience, School of Medical Sciences, State University of Campinas-UNICAMP, Campinas, Brazil.
Karen L FerrariDepartment of UroScience, School of Medical Sciences, State University of Campinas-UNICAMP, Campinas, Brazil.
Ana Carolina PagliaroneDepartment of UroScience, School of Medical Sciences, State University of Campinas-UNICAMP, Campinas, Brazil.
Patrícia A F LemeDepartment of UroScience, School of Medical Sciences, State University of Campinas-UNICAMP, Campinas, Brazil.
Cristiane L MaiaDepartment of UroScience, School of Medical Sciences, State University of Campinas-UNICAMP, Campinas, Brazil.
Reza YadollahvandmiandoabDepartment of UroScience, School of Medical Sciences, State University of Campinas-UNICAMP, Campinas, Brazil.
Quoc-Dien TrinhBrigham and Women's Center for Surgery and Public Health, Harvard Medical School, Boston, Massachusetts, USA.
Kleber G FranchiniBrazilian Center for Research in Energy and Materials, CNPEM, Brazilian Biosciences National Laboratory-LNBio, Campinas, Brazil.
Marcio C BajgelmanBrazilian Center for Research in Energy and Materials, CNPEM, Brazilian Biosciences National Laboratory-LNBio, Campinas, Brazil.
Leonardo O ReisDepartment of UroScience, School of Medical Sciences, State University of Campinas-UNICAMP, Campinas, Brazil.ORCID 0000-0003-2092-414X
Universidade Estadual de Campinas (UNICAMP) · BRBrazilian Center for Research in Energy and Materials · BRBrigham and Women's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Bacillus Calmette-Guérin (BCG) vaccine may confer cross-protection against viral diseases in adults. This study evaluated BCG vaccine cross-protection in adults with convalescent coronavirus disease 2019 (COVID-19).

methodThis was a multicenter, prospective, randomized, placebo-controlled, double-blind phase III study (ClinicalTrials.gov: NCT04369794).

settingUniversity Community Health Center and Municipal Outpatient Center in South America. PATIENTS: a total of 378 adult patients with convalescent COVID-19 were included.

interventionsingle intradermal BCG vaccine (n = 183) and placebo (n = 195). MEASUREMENTS: the primary outcome was clinical evolution. Other outcomes included adverse events and humoral immune responses for up to 6 months.

resultsA significantly higher proportion of BCG patients with anosmia and ageusia recovered at the 6-week follow-up visit than placebo (anosmia: 83.1% vs. 68.7% healed, p = 0.043, number needed to treat [NNT] = 6.9; ageusia: 81.2% vs. 63.4% healed, p = 0.032, NNT = 5.6). BCG also prevented the appearance of ageusia in the following weeks: seven in 113 (6.2%) BCG recipients versus 19 in 126 (15.1%) placebos, p = 0.036, NNT = 11.2. BCG did not induce any severe or systemic adverse effects. The most common and expected adverse effects were local vaccine lesions, erythema (n = 152; 86.4%), and papules (n = 111; 63.1%). Anti-severe acute respiratory syndrome coronavirus 2 humoral response measured by N protein immunoglobulin G titer and seroneutralization by interacting with the angiotensin-converting enzyme 2 receptor suggest that the serum of BCG-injected patients may neutralize the virus at lower specificity; however, the results were not statistically significant.

conclusionBCG vaccine is safe and offers cross-protection against COVID-19 with potential humoral response modulation. LIMITATIONS: No severely ill patients were included.

Indexed as

AgeusiaCOVID-19AdultAngiotensin-Converting Enzyme 2AnosmiaBCG VaccineDouble-Blind MethodHumansImmunity, HumoralImmunoglobulin GProspective StudiesAngiotensin-Converting Enzyme 2BCG VaccineImmunoglobulin GBCGconvalescenceCOVID-19IgGimmunomodulationneutralizationsafetySARS-CoV-2

Identifiers

PMID35599154
PMCPMC9347570
OpenAlexW4281289706

What OpenQuestion holds

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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.