Evidence map›Paper›PMID 34368914›Full record

ArticleInfectious diseases and therapy2021

Phase II Clinical Trial of Combination Therapy with Favipiravir and Methylprednisolone for COVID-19 with Non-Critical Respiratory Failure.

Yuichiro Shindo, Yasuhiro Kondoh, Akiko Kada, Yohei Doi, Keisuke Tomii, Hiroshi Mukae, Naohiko Murata, Ryosuke Imai, Masaki Okamoto, Yasuhiko Yamano and 9 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Infectious diseases and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 39% 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

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Aprotinin-Drug against Respiratory Diseases.International journal of molecular sciences · 2023
    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 14 institutions in 1 country.

Yuichiro ShindoDepartment of Respiratory Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan. yshindo@med.nagoya-u.ac.jp.ORCID http://orcid.org/0000-0002-0207-9483
Yasuhiro KondohDepartment of Respiratory Medicine and Allergy, Tosei General Hospital, Seto, Japan.
Akiko KadaClinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Yohei DoiDepartment of Infectious Diseases, Fujita Health University School of Medicine, Toyoake, Japan.
Keisuke TomiiDepartment of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.
Hiroshi MukaeDepartment of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan.
Naohiko MurataDepartment of Respiratory Medicine, Nagoya Daini Red Cross Hospital, Nagoya, Japan.
Ryosuke ImaiDepartment of Pulmonary Medicine, St. Luke's International Hospital, Tokyo, Japan.
Masaki OkamotoDepartment of Respirology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Yasuhiko YamanoDepartment of Respiratory Medicine and Allergy, Tosei General Hospital, Seto, Japan.
Yasunari MiyazakiDepartment of Respiratory Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
Masahiro ShinodaDepartment of Respiratory Medicine, Tokyo Shinagawa Hospital, Tokyo, Japan.
Hiromichi AsoDepartment of Respiratory Medicine, Ichinomiya Municipal Hospital, Ichinomiya, Japan.
Shinyu IzumiDepartment of Respiratory Medicine, Center Hospital of the National Center for Global Health and Medicine, Tokyo, Japan.
Haruyuki IshiiDepartment of Respiratory Medicine, Kyorin University, Tokyo, Japan.
Ryota ItoDepartment of Infectious Diseases, Fujita Health University School of Medicine, Toyoake, Japan.
Akiko M SaitoClinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Toshiki I SaitoClinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Yoshinori HasegawaNational Hospital Organization Nagoya Medical Center, Nagoya, Japan.
National Hospital Organization · JPFujita Health University · JPTosei General Hospital · JPIchinomiya Municipal City Hospital · JPJapanese Red Cross Nagoya Daini Hospital · JPKobe City Medical Center General Hospital · JPKyorin University · JPNagasaki University Hospital · JPNagoya University · JPNational Center for Global Health and Medicine · JPNational Kyushu Medical Center · JPNew Tokyo Hospital · JPSt. Luke's International Hospital · JPTokyo Medical and Dental University · JP

Funding

Japan Agency for Medical Research and Development JP20fk0108256
6 · The paper itself

Abstract

introductionThe administration of systemic corticosteroids is a key strategy for improving COVID-19 outcomes. However, evidence is lacking on combination therapies of antiviral agents and systemic corticosteroids. The objective of this study was to investigate the efficacy and safety of the combination therapy of favipiravir and methylprednisolone in preventing respiratory failure progression in patients with COVID-19 and non-critical respiratory failure.

methodsWe conducted a multicenter, open-label, single-arm phase II study. The patients received favipiravir 3600 mg on the first day, followed by 1600 mg for a total of 10-14 days. Methylprednisolone was administered intravenously at 1 mg/ideal body weight (IBW)/day from days 1 to 5, followed by 0.5 mg/IBW/day from days 6 to 10 if clinically indicated. The primary endpoint was the proportion of patients requiring mechanical ventilation (MV) (including noninvasive positive pressure ventilation) or those who met the criteria for tracheal intubation within 14 days of the study treatment initiation (MVCTI-14).

resultsSixty-nine patients were enrolled and underwent the study treatment. Of them, the MVCTI-14 proportion was 29.2% (90% confidence interval 20.1-39.9, p = 0.200). The proportion of patients who required MV or who died within 30 days was 26.2%, and 30-day mortality was 4.9%. The most significant risk factor for MVCTI-14 was a smoking history (odds ratio 4.1, 95% confidence interval 1.2-14.2). The most common grade 3-4 treatment-related adverse event was hyperglycemia, which was observed in 21.7%.

conclusionThe MVCTI-14 proportion did not reach a favorable level in the clinical trial setting with the threshold of 35%. However, the proportion of MV or death within 30 days was 26.6%, which might be close to the findings (28.1%) of the RECOVERY trial, which showed the efficacy of dexamethasone for patients with COVID-19 and non-critical respiratory failure. Further evaluation of this combination therapy is needed. CLINICAL

trial registrationJapan Registry of Clinical Trials (jRCT) identifier jRCTs041200025.

Indexed as

Adverse eventsMechanical ventilationMortalitySevere acute respiratory syndrome coronavirus 2Systemic corticosteroids

Identifiers

PMID34368914
PMCPMC8349598
OpenAlexW3191846128

What OpenQuestion holds

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LicenceCC BY-NC
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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.