Evidence map›Paper›PMID 34607865›Full record

Trial reportBMJ open2021

Factors associated with mortality among moderate and severe patients with COVID-19 in India: a secondary analysis of a randomised controlled trial.

Joy John Mammen, Snehil Kumar, Lovely Thomas, Gunjan Kumar, Anand Zachariah, Lakshmanan Jeyaseelan, John Victor Peter, Anup Agarwal, Aparna Mukherjee, Pranab Chatterjee and 50 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.7field-weighted citation impact, top 13% 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

10 citing papers in PubMed, 27 citations in OpenAlex.

  1. Article
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  10. Observational
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

60 authors at 20 institutions in 1 country.

Joy John MammenTransfusion Medicine and Immunohaematology, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India joymammen@cmcvellore.ac.in.ORCID 0000-0003-4402-7371
Snehil KumarTransfusion Medicine and Immunohaematology, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.
Lovely ThomasMedical Intensive Care Unit, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.
Gunjan KumarClinical Trials and Health Systems Research Unit, ICMR, New Delhi, Delhi, India.
Anand ZachariahMedicine, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.
Lakshmanan JeyaseelanBiostatistics, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.ORCID 0000-0002-9090-3005
John Victor PeterMedical Intensive Care Unit, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.
Anup AgarwalClinical Trials and Health Systems Research Unit, ICMR, New Delhi, Delhi, India.
Aparna MukherjeeClinical Trials and Health Systems Research Unit, ICMR, New Delhi, Delhi, India.
Pranab ChatterjeeTranslational Global Health Policy and Research Cell, ICMR, New Delhi, Delhi, India.
Tarun BhatnagarICMR School of Public Health, National Institute of Epidemiology, Chennai, Tamil Nadu, India.ORCID 0000-0002-5603-1418
Jess Elizabeth RasalamTransfusion Medicine and Immunohaematology, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.
Binila ChackoMedical Intensive Care Unit, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.
Thenmozhi ManiBiostatistics, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.ORCID 0000-0002-3932-5625
Melvin JoyBiostatistics, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.ORCID 0000-0001-9323-994X
Priscilla RupaliInfectious Diseases, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.
Malathi MurugesanHospital Infection Control Committee, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.
Dolly DanielTransfusion Medicine and Immunohaematology, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.
B LathaTransfusion Medicine, Madras Medical College, Chennai, Tamil Nadu, India.
Sunita BundasTransfusion Medicine, SMS Medical College and Hospital, Jaipur, Rajasthan, India.
Vivek KumarCritical Care, Sir HN Reliance Foundation Hospital and Research Centre, Mumbai, Maharashtra, India.
Ravi DosiRespiratory Medicine, Sri Aurobindo Institute of Medical Sciences, Indore, Madhya Pradesh, India.
Janakkumar R KhambholjaInternal Medicine, Smt NHL Municipal Medical College, Ahmedabad, Gujarat, India.
Rosemarie de SouzaDepartment of Medicine, BYL Nair Charitable Hospital, Mumbai, India.
B Thrilok ChanderInternal Medicine, Gandhi Medical College and Hospital, Secunderabad-Padmarao Nagar, Telangana, India.ORCID 0000-0002-6151-3868
Shalini BahadurPathology, Government Institute of Medical Sciences, Noida, Uttar Pradesh, India.
Simmi DubeInternal Medicine, Gandhi Medical College Bhopal, Bhopal, Madhya Pradesh, India.
Amit SuriPulmonary Medicine, Atal Bihari Vajpayee Institute of Medical Sciences and Ram Manohar Lohia Hospital, New Delhi, Delhi, India.
Aikaj JindalTransfusion Medicine, Satguru Partap Singh Hospitals, Ludhiana, Punjab, India.
Om ShrivastavInfectious Diseases, Kasturba Hospital for Infectious Diseases, Mumbai, Maharashtra, India.
Vijay BargeMedicine, RCSM Government Medical College, Kolhapur, Maharashtra, India.
Archana BajpayeeTransfusion Medicine, AIIMS Jodhpur, Jodhpur, Rajasthan, India.
Pankaj MalhotraDepartment of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, Punjab, India.
Neha SinghTransfusion Medicine, AIIMS Patna, Patna, Bihar, India.
Muralidhar TambeDepartment of Community Medicine, B J Government Medical College, Pune, Maharashtra, India.
Nimisha SharmaTransfusion Medicine, ESIC Medical College and Hospital Faridabad, Faridabad, Haryana, India.
Shreepad BhatInternal Medicine, Smt Kashibai Navale Medical College and General Hospital, Pune, Maharashtra, India.
Ram S KaulgudInternal Medicine, Karnataka Institute of Medical Sciences, Hubli, Karnataka, India.
Anil GurtooInternal Medicine, Lady Hardinge Medical College, New Delhi, Delhi, India.
D Himanshu ReddyInternal Medicine, King George Medical College, Lucknow, Uttar Pradesh, India.
Kamlesh UpadhyayInternal Medicine, Byramjee Jeejeebhoy Medical College, Ahmedabad, Gujarat, India.
Ashish JainRespiratory Medicine, Mahatma Gandhi Medical College and Hospital, Jaipur, Rajasthan, India.
Tinkal C PatelInternal Medicine, Government Medical College, Surat, Gujarat, India.
Irfan NagoriMedicine, GMERS Medical College Gotri Vadodara, Vadodara, Gujarat, India.
Pramod R JhaInternal Medicine, Sumandeep Vidyapeeth University, Vadodara, Gujarat, India.
K V Sreedhar BabuTransfusion Medicine, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, India.
C AparnaPathology, Kurnool Medical College, Kurnool, Andhra Pradesh, India.
Sunil Jodharam PanjwaniInternal Medicine, Government Medical College, Bhavnagar, Gujarat, India.ORCID 0000-0003-2267-2804
M NatarajanInternal Medicine, Madurai Medical College, Madurai, Tamil Nadu, India.
Milind BaldiInternal Medicine, Mahatma Gandhi Memorial Medical College, Indore, Madhya Pradesh, UK.
Vrushali Khirid KhadkeInterventional Pulmonology, Poona Hospital and Research Centre, Pune, Maharashtra, India.
Seema DuaTransfusion Medicine, Super Speciality Paediatric Hospital and Teaching Hospital, Noida, Uttar Pradesh, India.
Ravindraa SinghTransfusion Medicine, Aditya Birla Memorial Hospital, Pune, Maharashtra, India.
Ashish SharmaMedicine, R D Gardi Medical College, Ujjain, Madhya Pradesh, India.
Jayashree SharmaTransfusion Medicine, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
Yojana A GokhaleInternal Medicine, Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, Maharashtra, India.
Pragya D YadavMaximum Containment Laboratory, ICMR, National Institute of Virology, Pune, Maharashtra, India.ORCID 0000-0002-0861-7166
Gajanan SapkalDiagnostic Virology Group, ICMR, National Institute of Virology, Pune, Maharashtra, India.
Himanshu KaushalHuman Influenza Group, ICMR, National Institute of Virology, Pune, Maharashtra, India.
V Saravana KumarEpidemiology and Biostatistics Division, National Institute of Epidemiology, Chennai, Tamil Nadu, India.
Christian Medical College, Vellore · INICMR-National Institute of Virology · INIndian Council of Medical Research · INGandhi Medical College & Hospital · INSir H.N. Reliance Foundation Hospital and Research Centre · INAditya Birla Memorial Hospital · INAll India Institute of Medical Sciences Jodhpur · INAll India Institute of Medical Sciences Raipur · INAtal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital · INB.J. Medical College · INESIC Hospital · INGandhi Medical College · INGovernment Medical College · INGovernment Medical College · INGovernment Medical College · INGovernment Medical College Bhavnagar · INInstitute of Medical Sciences · INKarnataka Institute of Medical Sciences · INKasturba Hospital · INKing Edward Memorial Hospital and Seth G.S. Medical College · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveLarge data on the clinical characteristics and outcome of COVID-19 in the Indian population are scarce. We analysed the factors associated with mortality in a cohort of moderately and severely ill patients with COVID-19 enrolled in a randomised trial on convalescent plasma.

designSecondary analysis of data from a Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications in Moderate Disease.

setting39 public and private hospitals across India during the study period from 22 April to 14 July 2020.

participantsOf the 464 patients recruited, two were lost to follow-up, nine withdrew consent and two patients did not receive the intervention after randomisation. The cohort of 451 participants with known outcome at 28 days was analysed. PRIMARY OUTCOME MEASURE: Factors associated with all-cause mortality at 28 days after enrolment.

resultsThe mean (SD) age was 51±12.4 years; 76.7% were males. Admission Sequential Organ Failure Assessment score was 2.4±1.1. Non-invasive ventilation, invasive ventilation and vasopressor therapy were required in 98.9%, 8.4% and 4.0%, respectively. The 28-day mortality was 14.4%. Median time from symptom onset to hospital admission was similar in survivors (4 days; IQR 3-7) and non-survivors (4 days; IQR 3-6). Patients with two or more comorbidities had 2.25 (95% CI 1.18 to 4.29, p=0.014) times risk of death. When compared with survivors, admission interleukin-6 levels were higher (p<0.001) in non-survivors and increased further on day 3. On multivariable Fine and Gray model, severity of illness (subdistribution HR 1.22, 95% CI 1.11 to 1.35, p<0.001), PaO

conclusionIn this cohort of moderately and severely ill patients with COVID-19, severity of illness, underlying comorbidities and elevated levels of inflammatory markers were significantly associated with death. TRIAL REGISTRATION NUMBER: CTRI/2020/04/024775.

Indexed as

COVID-19AdultCOVID-19 SerotherapyHumansImmunization, PassiveIndiaMiddle AgedSARS-CoV-2adult intensive & critical careCOVID-19public health

Identifiers

PMID34607865
PMCPMC8491003
OpenAlexW3204545243

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.