Evidence map›Paper›PMID 34428542›Full record

Trial reportInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2021

Efficacy and safety of pegylated interferon-α2b in moderate COVID-19: a phase 3, randomized, comparator-controlled, open-label study.

Shashi Bhushan B L, Sunil Wanve, Parshottam Koradia, Vinay Bhomia, Pravin Soni, Sisir Chakraborty, Akash Khobragade, Shashank Joshi, Sanjeev Kumar Mendiratta, Kevin Kumar Kansagra and 4 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

15 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. The role of SARS-CoV-2 accessory proteins in immune evasion.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2022
    Review
  10. Article
  11. Immune-based therapeutic approaches in COVID-19.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2022
    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

14 authors.

Shashi Bhushan B LDepartment of Pulmonary Medicine, Victoria Hospital, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India. Electronic address: shashibhushanbl@yahoo.com.
Sunil WanveBAJ RR Hospital and Research Centre, Dombivali East, Maharashtra, India.
Parshottam KoradiaBAPS Pramukh Swami Hospital, Surat, Gujarat, India.
Vinay BhomiaSanjivani Super Speciality Hospital, Ahmedabad, Gujarat, India.
Pravin SoniPCMC's, PGI, Yashwantrao Chavan Memorial Hospital, Pune, Maharashtra, India.
Sisir ChakrabortyCollege of Medicine and Sagore Dutta Hospital, Kamahati, Kolkata, West Bengal, India.
Akash KhobragadeSt. George's Hospital, Fort, Mumbai, Maharashtra, India.
Shashank JoshiJoshi Clinic, Mumbai, Maharashtra, India.
Sanjeev Kumar MendirattaZydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India.
Kevin Kumar KansagraZydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India.
Anurag PariharZydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India.
Sunil SharmaZydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India.
Jatin PatelZydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India.
Study Investigators Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of pegylated interferon alpha-2b (PEG IFN-α2b) administered in conjunction with the standard of care (SOC) in subjects with moderate coronavirus disease-19 (COVID-19).

methodsIn this study, adult subjects with confirmed moderate COVID-19 were randomized in a 1:1 ratio to receive either PEG IFN-α2b + SOC or SOC alone. The primary endpoint was a two-point improvement in clinical status on Day 11, measured by the World Health Organization's seven-point ordinal scale.

resultsOf 250 subjects, 120 were randomized to the PEG IFN-α2b + SOC arm and 130 were randomized to the SOC arm. The results for the PEG IFN + SOC arms vs the SOC arm for the proportion of subjects with a two-point improvement in the seven-point ordinal scale were 80.36% vs 68.18% (P=0.037) on Day 8, 91.60% vs 92.56% (P=0.781) on Day 11, and 94.12% vs 95.93% (P=0.515) on Day 15. There was a time-dependent decrease in the biomarkers in both arms, and no clinically significant changes in laboratory parameters. The safety profile was similar in both arms.

conclusionPEG IFN-α2b induced early viral clearance, improved the clinical status, and decreased the duration of supplemental oxygen. It provides a viable treatment option and can limit the spread of severe acute respiratory syndrome coronavirus-2.

Indexed as

COVID-19AdultAntiviral AgentsHumansInterferon-alphaInterferon alpha-2Polyethylene GlycolsRecombinant ProteinsSARS-CoV-2Treatment OutcomeAntiviral AgentsInterferon-alphaInterferon alpha-2Interferon-alpha2bPolyethylene GlycolsRecombinant ProteinsModerate subjectsPegylated interferon alpha-2b (PEG IFN-α2b)Phase 3SARS-CoV-2

Identifiers

PMID34428542
PMCPMC8379820

What OpenQuestion holds

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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.