Evidence map›Paper›PMID 35046397›Full record

Trial reportNature communications2022

A phase 2 single center open label randomised control trial for convalescent plasma therapy in patients with severe COVID-19.

Yogiraj Ray, Shekhar Ranjan Paul, Purbita Bandopadhyay, Ranit D'Rozario, Jafar Sarif, Deblina Raychaudhuri, Debaleena Bhowmik, Abhishake Lahiri, Janani Srinivasa Vasudevan, Ranjeet Maurya and 28 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 6 pooled it
4.2field-weighted citation impact, top 4% 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

28 citing papers in PubMed, 6 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Convalescent plasma for people with COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023
    Pooled it
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  3. Convalescent plasma for people with COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023
    Pooled it
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  5. Guideline
  6. Pooled it
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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

38 authors at 8 institutions in 2 countries.

Yogiraj RayInfectious Disease & Beleghata General Hospital, Kolkata, India. jaggs.nbmc@gmail.com.
Shekhar Ranjan PaulInfectious Disease & Beleghata General Hospital, Kolkata, India.
Purbita BandopadhyayIICB-Translational Research Unit of Excellence, CSIR-Indian Institute of Chemical Biology, Kolkata, India.
Ranit D'RozarioIICB-Translational Research Unit of Excellence, CSIR-Indian Institute of Chemical Biology, Kolkata, India.
Jafar SarifIICB-Translational Research Unit of Excellence, CSIR-Indian Institute of Chemical Biology, Kolkata, India.
Deblina RaychaudhuriIICB-Translational Research Unit of Excellence, CSIR-Indian Institute of Chemical Biology, Kolkata, India.
Debaleena BhowmikAcademy of Scientific and Innovative Research, Ghaziabad, India.
Abhishake LahiriAcademy of Scientific and Innovative Research, Ghaziabad, India.
Janani Srinivasa VasudevanCSIR-Institute of Genomics and Integrative Biology, Delhi, India.
Ranjeet MauryaCSIR-Institute of Genomics and Integrative Biology, Delhi, India.ORCID 0000-0002-0306-8970
Akshay KanakanCSIR-Institute of Genomics and Integrative Biology, Delhi, India.
Sachin SharmaCSIR-Institute of Genomics and Integrative Biology, Delhi, India.
Manish KumarCSIR-Institute of Genomics and Integrative Biology, Delhi, India.
Praveen SinghCSIR-Institute of Genomics and Integrative Biology, Delhi, India.
Rammohan RoyInfectious Disease & Beleghata General Hospital, Kolkata, India.ORCID 0000-0001-7273-4132
Kausik ChaudhuryInfectious Disease & Beleghata General Hospital, Kolkata, India.
Rajsekhar MaitiInfectious Disease & Beleghata General Hospital, Kolkata, India.
Saugata BagchiInfectious Disease & Beleghata General Hospital, Kolkata, India.
Ayan MaitiInfectious Disease & Beleghata General Hospital, Kolkata, India.
Md Masoom PerwezInfectious Disease & Beleghata General Hospital, Kolkata, India.
Abhinandan MondalInfectious Disease & Beleghata General Hospital, Kolkata, India.
Avinash TewariInfectious Disease & Beleghata General Hospital, Kolkata, India.
Samik MandalInfectious Disease & Beleghata General Hospital, Kolkata, India.
Arpan RoyInfectious Disease & Beleghata General Hospital, Kolkata, India.
Moumita SahaInfectious Disease & Beleghata General Hospital, Kolkata, India.
Durba BiswasDepartment of Immunohematology & Blood Transfusion, Medical College, Kolkata, India.
Chikam MaitiDepartment of Immunohematology & Blood Transfusion, Medical College, Kolkata, India.
Ritwik BhaduriIndian Statistical Institute, Kolkata, India.ORCID 0000-0002-1909-6167
Sayantan ChakrabortyDepartment of Critical Care Medicine, Tata Medical Center, Kolkata, India.
Biswanath Sharma SarkarInfectious Disease & Beleghata General Hospital, Kolkata, India.
Anima HaldarInfectious Disease & Beleghata General Hospital, Kolkata, India.
Bibhuti SahaDepartment of Tropical Medicine, School of Tropical Medicine, Kolkata, India.
Shantanu SenguptaAcademy of Scientific and Innovative Research, Ghaziabad, India.ORCID 0000-0001-8461-0735
Rajesh PandeyAcademy of Scientific and Innovative Research, Ghaziabad, India.
Shilpak ChatterjeeIICB-Translational Research Unit of Excellence, CSIR-Indian Institute of Chemical Biology, Kolkata, India.
Prasun BhattacharyaDepartment of Immunohematology & Blood Transfusion, Medical College, Kolkata, India.
Sandip PaulDivision of Structural Biology & Bioinformatics, CSIR-Indian Institute of Chemical Biology, Kolkata, India.ORCID 0000-0001-7406-3598
Dipyaman GangulyIICB-Translational Research Unit of Excellence, CSIR-Indian Institute of Chemical Biology, Kolkata, India. Dipyaman@iicb.res.in.ORCID 0000-0002-7786-1795
Indian Institute of Chemical Biology · INInstitute of Genomics and Integrative Biology · INKPC Medical College and Hospital · INCollege of Medicine & Sagore Dutta Hospital · INIndian Institute of Tropical Meteorology · INIndian Statistical Institute · INLBJ Tropical Medical Center · ASTata Medical Center · IN

Funding

Council of Scientific and Industrial Research (CSIR) MLP129
6 · The paper itself

Abstract

A single center open label phase 2 randomised control trial (Clinical Trial Registry of India No. CTRI/2020/05/025209) was done to assess clinical and immunological benefits of passive immunization using convalescent plasma therapy. At the Infectious Diseases and Beleghata General Hospital in Kolkata, India, 80 patients hospitalized with severe COVID-19 disease and fulfilling the inclusion criteria (aged more than 18 years, with either mild ARDS having PaO2/FiO2 200-300 or moderate ARDS having PaO2/FiO2 100-200, not on mechanical ventilation) were recruited and randomized into either standard of care (SOC) arm (N = 40) or the convalescent plasma therapy (CPT) arm (N = 40). Primary outcomes were all-cause mortality by day 30 of enrolment and immunological correlates of response to therapy if any, for which plasma abundance of a large panel of cytokines was quantitated before and after intervention to assess the effect of CPT on the systemic hyper-inflammation encountered in these patients. The secondary outcomes were recovery from ARDS and time taken to negative viral RNA PCR as well as to report any adverse reaction to plasma therapy. Transfused convalescent plasma was characterized in terms of its neutralizing antibody content as well as proteome. The trial was completed and it was found that primary outcome of all-cause mortality was not significantly different among severe COVID-19 patients with ARDS randomized to two treatment arms (Mantel-Haenszel Hazard Ratio 0.6731, 95% confidence interval 0.3010-1.505, with a P value of 0.3424 on Mantel-Cox Log-rank test). No adverse effect was reported with CPT. In severe COVID-19 patients with mild or moderate ARDS no significant clinical benefit was registered in this clinical trial with convalescent plasma therapy in terms of prespecified outcomes.

Indexed as

Antibodies, NeutralizingAntibodies, ViralBlood DonorsCOVID-19COVID-19 SerotherapyCytokinesFemaleHospitals, GeneralHumansImmunity, HumoralImmunization, PassiveIndiaInflammationMalePhylogenyRespiratory Distress SyndromeAntibodies, NeutralizingAntibodies, ViralCytokines

Identifiers

PMID35046397
PMCPMC8770561
OpenAlexW4205827837

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.