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Article: Association of gut microbial dysbiosis with disease severity, response to therapy and disease outcomes in Indian patients with COVID-19.

Talukdar, Daizee / Bandopadhyay, Purbita / Ray, Yogiraj / Paul, Shekhar Ranjan / Sarif, Jafar / D'Rozario, Ranit / Lahiri, Abhishake / Das, Santanu / Bhowmick, Debaleena / Chatterjee, Shilpak / Das, Bhabatosh / Ganguly, Dipyaman

Gut pathogens

2023 Volume 15, Issue 1, Page(s) 22

Abstract: Background: Severe coronavirus disease 2019 (COVID-19) is associated with systemic hyper-inflammation. An adaptive interaction between gut microbiota and host immune systems is important for intestinal homeostasis and systemic immune regulation. The ... ...

Abstract	Background: Severe coronavirus disease 2019 (COVID-19) is associated with systemic hyper-inflammation. An adaptive interaction between gut microbiota and host immune systems is important for intestinal homeostasis and systemic immune regulation. The association of gut microbial composition and functions with COVID-19 disease severity is sparse, especially in India. We analysed faecal microbial diversity and abundances in a cohort of Indian COVID-19 patients to identify key signatures in the gut microbial ecology in patients with severe COVID-19 disease as well as in response to different therapies. The composition of the gut microbiome was characterized using 16Sr RNA gene sequences of genomic DNA extracted from faecal samples of 52 COVID-19 patients. Metabolic pathways across the groups were predicted using PICRUSt2. All statistical analyses were done using Vegan in the R environment. Plasma cytokine abundance at recruitment was measured in a multiplex assay. Results: The gut microbiome composition of mild and severe patients was found to be significantly different. Immunomodulatory commensals, viz. Lachnospiraceae family members and Bifidobacteria producing butyrate and short-chain fatty acids (SCFAs), were under represented in patients with severe COVID-19, with an increased abundance of opportunistic pathogens like Eggerthella. The higher abundance of Lachnoclostridium in severe disease was reduced in response to convalescent plasma therapy. Specific microbial genera showed distinctive trends in enriched metabolic pathways, strong correlations with blood plasma cytokine levels, and associative link to disease outcomes. Conclusion: Our study indicates that, along with SARS-CoV-2, a dysbiotic gut microbial community may also play an important role in COVID-19 severity through modulation of host immune responses.
Language	English
Publishing date	2023-05-10
Publishing country	England
Document type	Journal Article
ZDB-ID	2478277-4
ISSN	1757-4749
ISSN	1757-4749
DOI	10.1186/s13099-023-00546-z
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Article ; Online: Circulating Interleukin-8 Dynamics Parallels Disease Course and Is Linked to Clinical Outcomes in Severe COVID-19.

D'Rozario, Ranit / Raychaudhuri, Deblina / Bandopadhyay, Purbita / Sarif, Jafar / Mehta, Priyanka / Liu, Chinky Shiu Chen / Sinha, Bishnu Prasad / Roy, Jayasree / Bhaduri, Ritwik / Das, Monidipa / Bandyopadhyay, Sanghamitra / Paul, Shekhar Ranjan / Chatterjee, Shilpak / Pandey, Rajesh / Ray, Yogiraj / Ganguly, Dipyaman

Viruses

2023 Volume 15, Issue 2

Abstract: Severe COVID-19 frequently features a systemic deluge of cytokines. Circulating cytokines that can stratify risks are useful for more effective triage and management. Here, we ran a machine-learning algorithm on a dataset of 36 plasma cytokines in a ... ...

Abstract	Severe COVID-19 frequently features a systemic deluge of cytokines. Circulating cytokines that can stratify risks are useful for more effective triage and management. Here, we ran a machine-learning algorithm on a dataset of 36 plasma cytokines in a cohort of severe COVID-19 to identify cytokine/s useful for describing the dynamic clinical state in multiple regression analysis. We performed RNA-sequencing of circulating blood cells collected at different time-points. From a Bayesian Information Criterion analysis, a combination of interleukin-8 (IL-8), Eotaxin, and Interferon-γ (IFNγ) was found to be significantly linked to blood oxygenation over seven days. Individually testing the cytokines in receiver operator characteristics analyses identified IL-8 as a strong stratifier for clinical outcomes. Circulating IL-8 dynamics paralleled disease course. We also revealed key transitions in immune transcriptome in patients stratified for circulating IL-8 at three time-points. The study identifies plasma IL-8 as a key pathogenic cytokine linking systemic hyper-inflammation to the clinical outcomes in COVID-19.
MeSH term(s)	Humans ; Interleukin-8 ; Bayes Theorem ; COVID-19 ; Cytokines ; Disease Progression
Chemical Substances	Interleukin-8 ; Cytokines
Language	English
Publishing date	2023-02-16
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2516098-9
ISSN	1999-4915 ; 1999-4915
ISSN (online)	1999-4915
ISSN	1999-4915
DOI	10.3390/v15020549
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Article ; Online: Clinical Trial Subgroup Analyses to Investigate Clinical and Immunological Outcomes of Convalescent Plasma Therapy in Severe COVID-19.

Raychaudhuri, Deblina / Bandopadhyay, Purbita / D'Rozario, Ranit / Sarif, Jafar / Ray, Yogiraj / Paul, Shekhar Ranjan / Singh, Praveen / Chaudhuri, Kausik / Bhaduri, Ritwik / Pandey, Rajesh / Bhattacharya, Prasun / Sengupta, Shantanu / Chatterjee, Shilpak / Ganguly, Dipyaman

Mayo Clinic proceedings. Innovations, quality & outcomes

2022 Volume 6, Issue 6, Page(s) 511–524

Abstract: Objective: To assess the clinical and immunological benefits of passive immunization using convalescent plasma therapy (CPT).: Materials and methods: A series of subclass analyses were performed on the previously published outcome data and ... ...

Abstract	Objective: To assess the clinical and immunological benefits of passive immunization using convalescent plasma therapy (CPT). Materials and methods: A series of subclass analyses were performed on the previously published outcome data and accompanying clinical metadata from a completed randomized controlled trial (RCT) (Clinical Trial Registry of India, number CTRI/2020/05/025209). The subclass analyses were performed on the outcome data and accompanying clinical metadata from a completed RCT (patient recruitment between May 15, 2020 and October 31, 2020). Data on the plasma abundance of a large panel of cytokines from the same cohort of patients were also used to characterize the heterogeneity of the putative anti-inflammatory function of convalescent plasma (CP) in addition to passively providing neutralizing antibodies. Results: Although the primary clinical outcomes were not significantly different in the RCT across all age groups, significant immediate mitigation of hypoxia, reduction in hospital stay, and significant survival benefit were registered in younger (<67 years in our cohort) patients with severe coronavirus disease 2019 and acute respiratory distress syndrome on receiving CPT. In addition to neutralizing the antibody content of CP, its anti-inflammatory proteome, by attenuation of the systemic cytokine deluge, significantly contributed to the clinical benefits of CPT. Conclusion: Subgroup analyses revealed that clinical benefits of CPT in severe coronavirus disease 2019 are linked to the anti-inflammatory protein content of CP apart from the anti-severe acute respiratory syndrome coronavirus 2 neutralizing antibody content.
Language	English
Publishing date	2022-09-14
Publishing country	Netherlands
Document type	Journal Article
ISSN	2542-4548
ISSN (online)	2542-4548
DOI	10.1016/j.mayocpiqo.2022.09.001
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Article ; Online: Post-COVID-19 tele-survey for persistent symptoms in a single center hospital cohort in India along with a parallel country-wide web-survey

Chaudhuri, Kausik / Sarkar, Jit / Das, Tirthankar / Paul, Shekhar Ranjan / Basu, Rajita / Gangopadhyay, Supratik / Gangopadhyay, Devyani / Manna, Asis / Haldar, Anima / Ray, Yogiraj / Banerjee, Sayantan / Ganguly, Dipyaman

medRxiv

Abstract: Introduction A major concern amidst the ongoing coronavirus pandemic has been the longer term persistence of morbidities in individuals recovering from COVID-19 disease, called long COVID. We aimed at documenting the prevalence and key associations of ... ...

Abstract	Introduction A major concern amidst the ongoing coronavirus pandemic has been the longer term persistence of morbidities in individuals recovering from COVID-19 disease, called long COVID. We aimed at documenting the prevalence and key associations of post-COVID symptoms (PCS) in India in telephonic survey among recovered patients in a single hospital in eastern India as well as a parallel web-survey covering a wider population of the country. Methods Self-reported PCS, ranging up to one year since the original COVID-19 diagnosis, were documented in a telephonic survey of subjects (analyzed N=986), treated for acute COVID-19 in Infectious Diseases and Beleghata General Hospital, Kolkata, between April 1, 2020 and April 13, 2021. In parallel, we ran a web-based survey (analyzed N=580), to evaluate concordance. Results Shortness of breath, fatigue and insomnia were identified to be the most commonly reported PCS in both the surveys, with higher prevalence in females. In the telephonic survey, a 3.65% post-discharge mortality was registered within a median of 39 days since COVID diagnosis. Intensive care during acute disease and hypertension were more often associated with PCS, while fatigue was more often reported by the 20-40 years age-group. The web-survey revealed a gradual decline in PCS with time since COVID-19 diagnosis and type 2 diabetes to be associated with higher prevalence of these symptoms. Conclusions We assessed the predominant PCS among Indian COVID-19 patients and identified key demographic and clinical associations in our surveys, which warrants deeper epidemiological and mechanistic studies for guiding management of long-COVID in the country.
Keywords	covid19
Language	English
Publishing date	2022-02-21
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2022.02.20.22271119
Database	COVID19

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Article ; Online: Plasma Gradient of Soluble Urokinase-Type Plasminogen Activator Receptor Is Linked to Pathogenic Plasma Proteome and Immune Transcriptome and Stratifies Outcomes in Severe COVID-19.

Sarif, Jafar / Raychaudhuri, Deblina / D'Rozario, Ranit / Bandopadhyay, Purbita / Singh, Praveen / Mehta, Priyanka / Hoque, Md Asmaul / Sinha, Bishnu Prasad / Kushwaha, Manoj / Sahni, Shweta / Devi, Priti / Chattopadhyay, Partha / Paul, Shekhar Ranjan / Ray, Yogiraj / Chaudhuri, Kausik / Banerjee, Sayantan / Majumdar, Debajyoti / Saha, Bibhuti / Sarkar, Biswanath Sharma /

Bhattacharya, Prasun / Chatterjee, Shilpak / Paul, Sandip / Ghosh, Pramit / Pandey, Rajesh / Sengupta, Shantanu / Ganguly, Dipyaman

Frontiers in immunology

2021 Volume 12, Page(s) 738093

Abstract: Disease caused by SARS-CoV-2 coronavirus (COVID-19) led to significant morbidity and mortality worldwide. A systemic hyper-inflammation characterizes severe COVID-19 disease, often associated with acute respiratory distress syndrome (ARDS). Blood ... ...

Abstract	Disease caused by SARS-CoV-2 coronavirus (COVID-19) led to significant morbidity and mortality worldwide. A systemic hyper-inflammation characterizes severe COVID-19 disease, often associated with acute respiratory distress syndrome (ARDS). Blood biomarkers capable of risk stratification are of great importance in effective triage and critical care of severe COVID-19 patients. Flow cytometry and next-generation sequencing were done on peripheral blood cells and urokinase-type plasminogen activator receptor (suPAR), and cytokines were measured from and mass spectrometry-based proteomics was done on plasma samples from an Indian cohort of COVID-19 patients. Publicly available single-cell RNA sequencing data were analyzed for validation of primary data. Statistical analyses were performed to validate risk stratification. We report here higher plasma abundance of suPAR, expressed by an abnormally expanded myeloid cell population, in severe COVID-19 patients with ARDS. The plasma suPAR level was found to be linked to a characteristic plasma proteome, associated with coagulation disorders and complement activation. Receiver operator characteristic curve analysis to predict mortality identified a cutoff value of suPAR at 1,996.809 pg/ml (odds ratio: 2.9286, 95% confidence interval 1.0427-8.2257). Lower-than-cutoff suPAR levels were associated with a differential expression of the immune transcriptome as well as favorable clinical outcomes, in terms of both survival benefit (hazard ratio: 0.3615, 95% confidence interval 0.1433-0.912) and faster disease remission in our patient cohort. Thus, we identified suPAR as a key pathogenic circulating molecule linking systemic hyperinflammation to the hypercoagulable state and stratifying clinical outcomes in severe COVID-19 patients with ARDS.
MeSH term(s)	Adult ; Aged ; Blood Coagulation Disorders/blood ; Blood Coagulation Disorders/immunology ; Blood Proteins/analysis ; COVID-19/blood ; COVID-19/immunology ; Cytokines/blood ; Humans ; Inflammation/blood ; Inflammation/immunology ; Middle Aged ; Myeloid Cells/immunology ; Proteome/analysis ; Randomized Controlled Trials as Topic ; Receptors, Urokinase Plasminogen Activator/blood ; Respiratory Distress Syndrome/blood ; Respiratory Distress Syndrome/immunology ; SARS-CoV-2 ; Severity of Illness Index ; Young Adult
Chemical Substances	Blood Proteins ; Cytokines ; PLAUR protein, human ; Proteome ; Receptors, Urokinase Plasminogen Activator
Language	English
Publishing date	2021-10-28
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2021.738093
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Article ; Online: Nature and Dimensions of Systemic Hyperinflammation and its Attenuation by Convalescent Plasma in Severe COVID-19.

Bandopadhyay, Purbita / D'Rozario, Ranit / Lahiri, Abhishake / Sarif, Jafar / Ray, Yogiraj / Paul, Shekhar Ranjan / Roy, Rammohan / Maiti, Rajshekhar / Chaudhuri, Kausik / Bagchi, Saugata / Maiti, Ayan / Perwez, Mohammed Masoom / Sarkar, Biswanath Sharma / Roy, Devlina / Chakraborty, Rahul / Vasudevan, Janani Srinivasa / Sharma, Sachin / Biswas, Durba / Maiti, Chikam /

Saha, Bibhuti / Bhattacharya, Prasun / Pandey, Rajesh / Chatterjee, Shilpak / Paul, Sandip / Ganguly, Dipyaman

The Journal of infectious diseases

2021 Volume 224, Issue 4, Page(s) 565–574

Abstract: Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), causing coronavirus disease 2019 (COVID-19), has led to significant morbidity and mortality. While most suffer from mild symptoms, some patients progress to severe disease with ... ...

Abstract	Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), causing coronavirus disease 2019 (COVID-19), has led to significant morbidity and mortality. While most suffer from mild symptoms, some patients progress to severe disease with acute respiratory distress syndrome (ARDS) and associated systemic hyperinflammation. Methods: First, to characterize key cytokines and their dynamics in this hyperinflammatory condition, we assessed abundance and correlative expression of a panel of 48 cytokines in patients progressing to ARDS as compared to patients with mild disease. Then, in an ongoing randomized controlled trial of convalescent plasma therapy (CPT), we analyzed rapid effects of CPT on the systemic cytokine dynamics as a correlate for the level of hypoxia experienced by the patients. Results: We identified an anti-inflammatory role of CPT independent of its neutralizing antibody content. Conclusions: Neutralizing antibodies, as well as reductions in circulating interleukin-6 and interferon-γ-inducible protein 10, contributed to marked rapid reductions in hypoxia in response to CPT. Clinical trial registry of india: CTRI/2020/05/025209. http://www.ctri.nic.in/.
MeSH term(s)	Adult ; Anti-Inflammatory Agents/therapeutic use ; Antibodies, Neutralizing/immunology ; COVID-19/epidemiology ; COVID-19/immunology ; COVID-19/therapy ; COVID-19/virology ; Cytokines/blood ; Cytokines/immunology ; Female ; Humans ; Immunization, Passive/methods ; India/epidemiology ; Male ; Middle Aged ; Plasma ; RNA, Viral/isolation & purification ; Respiratory Distress Syndrome/drug therapy ; Respiratory Distress Syndrome/immunology ; SARS-CoV-2/immunology ; SARS-CoV-2/isolation & purification ; Viral Load ; COVID-19 Drug Treatment ; COVID-19 Serotherapy
Chemical Substances	Anti-Inflammatory Agents ; Antibodies, Neutralizing ; Cytokines ; RNA, Viral
Language	English
Publishing date	2021-08-13
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	3019-3
ISSN	1537-6613 ; 0022-1899
ISSN (online)	1537-6613
ISSN	0022-1899
DOI	10.1093/infdis/jiab010
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Article ; Online: A phase 2 single center open label randomised control trial for convalescent plasma therapy in patients with severe COVID-19.

Ray, Yogiraj / Paul, Shekhar Ranjan / Bandopadhyay, Purbita / D'Rozario, Ranit / Sarif, Jafar / Raychaudhuri, Deblina / Bhowmik, Debaleena / Lahiri, Abhishake / Vasudevan, Janani Srinivasa / Maurya, Ranjeet / Kanakan, Akshay / Sharma, Sachin / Kumar, Manish / Singh, Praveen / Roy, Rammohan / Chaudhury, Kausik / Maiti, Rajsekhar / Bagchi, Saugata / Maiti, Ayan /

Perwez, Md Masoom / Mondal, Abhinandan / Tewari, Avinash / Mandal, Samik / Roy, Arpan / Saha, Moumita / Biswas, Durba / Maiti, Chikam / Bhaduri, Ritwik / Chakraborty, Sayantan / Sarkar, Biswanath Sharma / Haldar, Anima / Saha, Bibhuti / Sengupta, Shantanu / Pandey, Rajesh / Chatterjee, Shilpak / Bhattacharya, Prasun / Paul, Sandip / Ganguly, Dipyaman

Nature communications

2022 Volume 13, Issue 1, Page(s) 383

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 ... ...

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.
MeSH term(s)	Antibodies, Neutralizing/immunology ; Antibodies, Neutralizing/therapeutic use ; Antibodies, Viral/immunology ; Antibodies, Viral/therapeutic use ; Blood Donors ; COVID-19/immunology ; COVID-19/therapy ; COVID-19/virology ; Cytokines/blood ; Female ; Hospitals, General ; Humans ; Immunity, Humoral ; Immunization, Passive ; India ; Inflammation ; Male ; Phylogeny ; Respiratory Distress Syndrome/immunology ; Respiratory Distress Syndrome/therapy ; Respiratory Distress Syndrome/virology ; SARS-CoV-2/classification ; SARS-CoV-2/genetics ; SARS-CoV-2/immunology ; Survival Analysis ; Treatment Outcome ; Viral Load
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral ; Cytokines
Language	English
Publishing date	2022-01-19
Publishing country	England
Document type	Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2553671-0
ISSN	2041-1723 ; 2041-1723
ISSN (online)	2041-1723
ISSN	2041-1723
DOI	10.1038/s41467-022-28064-7
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Article ; Online: Plasma gradient of soluble urokinase-type plasminogen activator receptor is linked to pathogenic plasma proteome and immune transcriptome and stratifies outcomes in severe COVID-19

Sarif, Jafar / Raychaudhuri, Deblina / D'Rozario, Ranit / Bandopadhyay, Purbita / Singh, Praveen / Mehta, Priyanka / Hoque, Md. Asmaul / Sinha, Bishnu Prasad / Kushwaha, Manoj / Sahni, Shweta / Devi, Priti / Chattopadhyay, Partha / Paul, Shekhar Ranjan / Ray, Yogiraj / Chaudhuri, Kausik / Banerjee, Sayantan / Majumdar, Debajyoti / Saha, Bibhuti / Sharma Sarkar, Biswanath /

Bhattacharya, Prasun / Chatterjee, Shilpak / Paul, Sandip / Ghosh, Pramit / Pandey, Rajesh / Sengupta, Shantanu / Ganguly, Dipyaman

medRxiv

Abstract: Disease caused by SARS-CoV-2 coronavirus (COVID-19) has resulted in significant morbidity and mortality world-wide. A systemic hyper-inflammation characterizes the severe COVID-19 disease often associated with acute respiratory distress syndrome (ARDS). ... ...

Abstract	Disease caused by SARS-CoV-2 coronavirus (COVID-19) has resulted in significant morbidity and mortality world-wide. A systemic hyper-inflammation characterizes the severe COVID-19 disease often associated with acute respiratory distress syndrome (ARDS). Blood biomarkers capable of risk stratification are of great importance in effective triage and critical care of severe COVID-19 patients. In the present study we report higher plasma abundance of soluble urokinase-type plasminogen activator receptor (sUPAR), expressed by an abnormally expanded circulating myeloid cell population, in severe COVID-19 patients with ARDS. Plasma sUPAR level was found to be linked to a characteristic proteomic signature of plasma, linked to coagulation disorders and complement activation. Receiver operator characteristics curve analysis identified a cut-off value of sUPAR at 1996.809 pg/ml that could predict survival in our cohort (Odds ratio: 2.9286, 95% confidence interval 1.0427-8.2257). Lower sUPAR level than this threshold concentration was associated with a differential expression of the immune transcriptome as well as favourable clinical outcomes, both in terms of survival benefit (Hazard ratio: 0.3615, 95% confidence interval 0.1433-0.912) and faster disease remission in our patient cohort. Thus we identified sUPAR as a key pathogenic circulating molecule linking systemic hyperinflammation to the hypercoagulable state and stratifying clinical outcomes in severe COVID-19 patients with ARDS.
Keywords	covid19
Language	English
Publishing date	2021-06-21
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2021.06.19.21259125
Database	COVID19

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Article ; Online: Development and Validation of a Treatment Benefit Index to Identify Hospitalized Patients With COVID-19 Who May Benefit From Convalescent Plasma.

Park, Hyung / Tarpey, Thaddeus / Liu, Mengling / Goldfeld, Keith / Wu, Yinxiang / Wu, Danni / Li, Yi / Zhang, Jinchun / Ganguly, Dipyaman / Ray, Yogiraj / Paul, Shekhar Ranjan / Bhattacharya, Prasun / Belov, Artur / Huang, Yin / Villa, Carlos / Forshee, Richard / Verdun, Nicole C / Yoon, Hyun Ah / Agarwal, Anup /

Simonovich, Ventura Alejandro / Scibona, Paula / Burgos Pratx, Leandro / Belloso, Waldo / Avendaño-Solá, Cristina / Bar, Katharine J / Duarte, Rafael F / Hsue, Priscilla Y / Luetkemeyer, Anne F / Meyfroidt, Geert / Nicola, André M / Mukherjee, Aparna / Ortigoza, Mila B / Pirofski, Liise-Anne / Rijnders, Bart J A / Troxel, Andrea / Antman, Elliott M / Petkova, Eva

JAMA network open

2022 Volume 5, Issue 1, Page(s) e2147375

Abstract: Importance: Identifying which patients with COVID-19 are likely to benefit from COVID-19 convalescent plasma (CCP) treatment may have a large public health impact.: Objective: To develop an index for predicting the expected relative treatment benefit ...

Abstract	Importance: Identifying which patients with COVID-19 are likely to benefit from COVID-19 convalescent plasma (CCP) treatment may have a large public health impact. Objective: To develop an index for predicting the expected relative treatment benefit from CCP compared with treatment without CCP for patients hospitalized for COVID-19 using patients' baseline characteristics. Design, setting, and participants: This prognostic study used data from the COMPILE study, ie, a meta-analysis of pooled individual patient data from 8 randomized clinical trials (RCTs) evaluating CCP vs control in adults hospitalized for COVID-19 who were not receiving mechanical ventilation at randomization. A combination of baseline characteristics, termed the treatment benefit index (TBI), was developed based on 2287 patients in COMPILE using a proportional odds model, with baseline characteristics selected via cross-validation. The TBI was externally validated on 4 external data sets: the Expanded Access Program (1896 participants), a study conducted under Emergency Use Authorization (210 participants), and 2 RCTs (with 80 and 309 participants). Exposure: Receipt of CCP. Main outcomes and measures: World Health Organization (WHO) 11-point ordinal COVID-19 clinical status scale and 2 derivatives of it (ie, WHO score of 7-10, indicating mechanical ventilation to death, and WHO score of 10, indicating death) at day 14 and day 28 after randomization. Day 14 WHO 11-point ordinal scale was used as the primary outcome to develop the TBI. Results: A total of 2287 patients were included in the derivation cohort, with a mean (SD) age of 60.3 (15.2) years and 815 (35.6%) women. The TBI provided a continuous gradation of benefit, and, for clinical utility, it was operationalized into groups of expected large clinical benefit (B1; 629 participants in the derivation cohort [27.5%]), moderate benefit (B2; 953 [41.7%]), and potential harm or no benefit (B3; 705 [30.8%]). Patients with preexisting conditions (diabetes, cardiovascular and pulmonary diseases), with blood type A or AB, and at an early COVID-19 stage (low baseline WHO scores) were expected to benefit most, while those without preexisting conditions and at more advanced stages of COVID-19 could potentially be harmed. In the derivation cohort, odds ratios for worse outcome, where smaller odds ratios indicate larger benefit from CCP, were 0.69 (95% credible interval [CrI], 0.48-1.06) for B1, 0.82 (95% CrI, 0.61-1.11) for B2, and 1.58 (95% CrI, 1.14-2.17) for B3. Testing on 4 external datasets supported the validation of the derived TBIs. Conclusions and relevance: The findings of this study suggest that the CCP TBI is a simple tool that can quantify the relative benefit from CCP treatment for an individual patient hospitalized with COVID-19 that can be used to guide treatment recommendations. The TBI precision medicine approach could be especially helpful in a pandemic.
MeSH term(s)	Aged ; Blood Grouping and Crossmatching ; COVID-19/therapy ; Comorbidity ; Female ; Hospitalization ; Humans ; Immunization, Passive ; Male ; Middle Aged ; Odds Ratio ; Pandemics ; Patient Selection ; Plasma ; Respiration, Artificial ; SARS-CoV-2 ; Severity of Illness Index ; Therapeutic Index ; Treatment Outcome ; World Health Organization ; COVID-19 Serotherapy
Language	English
Publishing date	2022-01-04
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Validation Study
ISSN	2574-3805
ISSN (online)	2574-3805
DOI	10.1001/jamanetworkopen.2021.47375
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Article ; Online: Nature and dimensions of the cytokine storm and its attenuation by convalescent plasma in severe COVID-19

Bandopadhyay, Purbita / D'Rozario, Ranit / Lahiri, Abhishake / Sarif, Jafar / Ray, Yogiraj / Paul, Shekhar Ranjan / Roy, Rammohan / Maiti, Rajsekhar / Chaudhuri, Kausik / Bagchi, Sougata / Maiti, Ayan / Parwez, Md. Masoom / Sharma Sarkar, Biswanath / Roy, Devlina / Chakraborty, Rahul / Vasudevan, Janani Srinivasa / Sharma, Sachin / Biswas, Durba / Maiti, Chikam /

Saha, Bibhuti / Bhattacharya, Prasun / Pandey, Rajesh / Chatterjee, Shilpak / Paul, Sandip / Ganguly, Dipyaman

medRxiv

Abstract: In a randomized control trial on convalescent plasma therapy (CPT) in severe COVID-19, we characterized the nature, in terms of abundance of forty eight cytokines, and dimensions, in terms of their interrelationships, of the hyper-immune activation- ... ...

Abstract	In a randomized control trial on convalescent plasma therapy (CPT) in severe COVID-19, we characterized the nature, in terms of abundance of forty eight cytokines, and dimensions, in terms of their interrelationships, of the hyper-immune activation-associated cytokine storm in patients suffering from acute respiratory distress syndrome. We found plasma MCP3 level to be a key correlate for mitigation of hypoxia, irrespective of therapeutic regimen. We also identified an anti-inflammatory role of CPT independent of its neutralizing antibody content, and a linear regression analysis revealed that neutralizing antibodies as well as the anti-inflammatory effect of CPT both contribute to marked immediate reductions in hypoxia, as compared to patients on standard therapy.
Keywords	covid19
Language	English
Publishing date	2020-09-23
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2020.09.21.20199109
Database	COVID19

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