Evidence map›Paper›PMID 33713817›Full record

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

Efficacy and safety of pegylated interferon alfa-2b in moderate COVID-19: A phase II, randomized, controlled, open-label study.

Anuja Pandit, Nirav Bhalani, B L Shashi Bhushan, Parshottam Koradia, Shweta Gargiya, Vinay Bhomia, Kevinkumar Kansagra

Erratum issuedOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized 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. An erratum has been issued. Cited by 40 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 5 pooled it
4.0field-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.

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

40 citing papers in PubMed, 5 syntheses or guidelines pooled it, 65 citations in OpenAlex.

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  6. Efficacy and safety of pegylated interferon-α2b in moderate COVID-19: a phase 3, randomized, comparator-controlled, open-label study.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2021
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 1 country.

Anuja PanditNational Cancer Institute, Badsa, Jhajjar, Haryana 124105, India.
Nirav BhalaniRhythm Heart Institute, Near Siddharth Bungalows, Sama Savli Road, Vadodara 390022, Gujarat, India.
B L Shashi BhushanVictoria Hospital, Bangalore Medical College & Research Institute, Fort K R Road, Bangalore Urban, Karnataka 560002, India.
Parshottam KoradiaBAPS Pramukh Swami Hospital, Shri Pramukh Swami Maharaj Marg, Adajan Char Road, Adajan, Surat 395009, Gujarat, India.
Shweta GargiyaTapan Research Centre, Basement Tapan Hospital Nr. Platinum Hall, Anandnagar Cross Road Satellite, Ahmedabad 380015, Gujarat, India.
Vinay BhomiaSanjivani Super Speciality Hospital, 1, Uday Park Society, Nr. Sunrise Park, Vastrapur, Ahmedabad 380015, Gujarat, India.
Kevinkumar KansagraZydus Research Centre, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad 382213, Gujarat, India. Electronic address: kevinkumarkansagra@zyduscadila.com.
Bangalore Medical College and Research Institute · INCadila Healthcare (India) · INCancer Institute (WIA) · INPramukhswami Medical College · INSanjivani Super Speciality Hospitals · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of pegylated interferon alfa-2b (PEG IFN-α2b) along with the standard of care (SOC) in subjects with moderate COVID-19.

methodsIn this phase 2, randomized, open-label study, adult subjects aged ≥18 years with RT-PCR confirmed COVID-19 with moderate symptoms were randomized in a 1:1 to receive PEG IFN-α2b plus SOC, or SOC alone. The primary endpoint was improvement in clinical status on day 15, measured by the WHO 7-point ordinal scale.

resultsForty subjects were randomized to PEG IFN-α2b plus SOC (n = 20) and SOC (n = 20). Overall, 19 (95.00%) subjects in PEG IFN-α2b plus SOC had achieved clinical improvement on day 15 compared to 13 (68.42%) subjects in SOC (p < 0.05). Overall, 80% and 95% of subjects in the PEG IFN-α2b plus SOC group had a negative RT-PCR result on day 7 and day 14, respectively, compared to 63% and 68% in the SOC group. Adverse events (AEs) were reported for eleven subjects in the PEG IFN-α2b plus SOC group and eight subjects in the SOC group. All reported AEs were mild.

conclusionThe significant improvement in clinical status on day 15 is likely due to faster viral reduction compared to SOC with the PEG IFN-α2b treated moderate COVID-19 subjects showing a difference as early as day seven and becoming significant by day 14.

Indexed as

COVID-19 Drug TreatmentSARS-CoV-2AdultAgedAntiviral AgentsFemaleHumansInterferon-alphaInterferon alpha-2MaleMiddle AgedPolyethylene GlycolsRecombinant ProteinsAntiviral AgentsInterferon-alphaInterferon alpha-2peginterferon alfa-2bPolyethylene GlycolsRecombinant ProteinsAntiviralCoronavirusCOVID-19Pegylated interferon alfa-2b (PEG IFN-α2b)

Identifiers

PMID33713817
PMCPMC7944859
OpenAlexW3139129256

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.