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

Authors
  • Mammen, Joy John1
  • Kumar, Snehil2
  • Thomas, Lovely3
  • Kumar, Gunjan4
  • Zachariah, Anand5
  • Jeyaseelan, Lakshmanan6
  • Peter, John Victor3
  • Agarwal, Anup4
  • Mukherjee, Aparna4
  • Chatterjee, Pranab7
  • Bhatnagar, Tarun8
  • Rasalam, Jess Elizabeth2
  • Chacko, Binila3
  • Mani, Thenmozhi6
  • Joy, Melvin6
  • Rupali, Priscilla9
  • Murugesan, Malathi10
  • Daniel, Dolly2
  • Latha, B11
  • Bundas, Sunita12
  • And 40 more
  • 1 Transfusion Medicine and Immunohaematology, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India [email protected] , (India)
  • 2 Transfusion Medicine and Immunohaematology, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India. , (India)
  • 3 Medical Intensive Care Unit, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India. , (India)
  • 4 Clinical Trials and Health Systems Research Unit, ICMR, New Delhi, Delhi, India. , (India)
  • 5 Medicine, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India. , (India)
  • 6 Biostatistics, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India. , (India)
  • 7 Translational Global Health Policy and Research Cell, ICMR, New Delhi, Delhi, India. , (India)
  • 8 ICMR School of Public Health, National Institute of Epidemiology, Chennai, Tamil Nadu, India. , (India)
  • 9 Infectious Diseases, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India. , (India)
  • 10 Hospital Infection Control Committee, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India. , (India)
  • 11 Transfusion Medicine, Madras Medical College, Chennai, Tamil Nadu, India. , (India)
  • 12 Transfusion Medicine, SMS Medical College and Hospital, Jaipur, Rajasthan, India. , (India)
  • 13 Critical Care, Sir HN Reliance Foundation Hospital and Research Centre, Mumbai, Maharashtra, India. , (India)
  • 14 Respiratory Medicine, Sri Aurobindo Institute of Medical Sciences, Indore, Madhya Pradesh, India. , (India)
  • 15 Internal Medicine, Smt NHL Municipal Medical College, Ahmedabad, Gujarat, India. , (India)
  • 16 Department of Medicine, BYL Nair Charitable Hospital, Mumbai, India. , (India)
  • 17 Internal Medicine, Gandhi Medical College and Hospital, Secunderabad-Padmarao Nagar, Telangana, India. , (India)
  • 18 Pathology, Government Institute of Medical Sciences, Noida, Uttar Pradesh, India. , (India)
  • 19 Internal Medicine, Gandhi Medical College Bhopal, Bhopal, Madhya Pradesh, India. , (India)
  • 20 Pulmonary Medicine, Atal Bihari Vajpayee Institute of Medical Sciences and Ram Manohar Lohia Hospital, New Delhi, Delhi, India. , (India)
  • 21 Transfusion Medicine, Satguru Partap Singh Hospitals, Ludhiana, Punjab, India. , (India)
  • 22 Infectious Diseases, Kasturba Hospital for Infectious Diseases, Mumbai, Maharashtra, India. , (India)
  • 23 Medicine, RCSM Government Medical College, Kolhapur, Maharashtra, India. , (India)
  • 24 Transfusion Medicine, AIIMS Jodhpur, Jodhpur, Rajasthan, India. , (India)
  • 25 Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, Punjab, India. , (India)
  • 26 Transfusion Medicine, AIIMS Patna, Patna, Bihar, India. , (India)
  • 27 Department of Community Medicine, B J Government Medical College, Pune, Maharashtra, India. , (India)
  • 28 Transfusion Medicine, ESIC Medical College and Hospital Faridabad, Faridabad, Haryana, India. , (India)
  • 29 Internal Medicine, Smt Kashibai Navale Medical College and General Hospital, Pune, Maharashtra, India. , (India)
  • 30 Internal Medicine, Karnataka Institute of Medical Sciences, Hubli, Karnataka, India. , (India)
  • 31 Internal Medicine, Lady Hardinge Medical College, New Delhi, Delhi, India. , (India)
  • 32 Internal Medicine, King George Medical College, Lucknow, Uttar Pradesh, India. , (India)
  • 33 Internal Medicine, Byramjee Jeejeebhoy Medical College, Ahmedabad, Gujarat, India. , (India)
  • 34 Respiratory Medicine, Mahatma Gandhi Medical College and Hospital, Jaipur, Rajasthan, India. , (India)
  • 35 Internal Medicine, Government Medical College, Surat, Gujarat, India. , (India)
  • 36 Medicine, GMERS Medical College Gotri Vadodara, Vadodara, Gujarat, India. , (India)
  • 37 Internal Medicine, Sumandeep Vidyapeeth University, Vadodara, Gujarat, India. , (India)
  • 38 Transfusion Medicine, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, India. , (India)
  • 39 Pathology, Kurnool Medical College, Kurnool, Andhra Pradesh, India. , (India)
  • 40 Internal Medicine, Government Medical College, Bhavnagar, Gujarat, India. , (India)
  • 41 Internal Medicine, Madurai Medical College, Madurai, Tamil Nadu, India. , (India)
  • 42 Internal Medicine, Mahatma Gandhi Memorial Medical College, Indore, Madhya Pradesh, UK.
  • 43 Interventional Pulmonology, Poona Hospital and Research Centre, Pune, Maharashtra, India. , (India)
  • 44 Transfusion Medicine, Super Speciality Paediatric Hospital and Teaching Hospital, Noida, Uttar Pradesh, India. , (India)
  • 45 Transfusion Medicine, Aditya Birla Memorial Hospital, Pune, Maharashtra, India. , (India)
  • 46 Medicine, R D Gardi Medical College, Ujjain, Madhya Pradesh, India. , (India)
  • 47 Transfusion Medicine, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India. , (India)
  • 48 Internal Medicine, Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, Maharashtra, India. , (India)
  • 49 Maximum Containment Laboratory, ICMR, National Institute of Virology, Pune, Maharashtra, India. , (India)
  • 50 Diagnostic Virology Group, ICMR, National Institute of Virology, Pune, Maharashtra, India. , (India)
  • 51 Human Influenza Group, ICMR, National Institute of Virology, Pune, Maharashtra, India. , (India)
  • 52 Epidemiology and Biostatistics Division, National Institute of Epidemiology, Chennai, Tamil Nadu, India. , (India)
Type
Published Article
Journal
BMJ Open
Publisher
BMJ
Publication Date
Oct 04, 2021
Volume
11
Issue
10
Identifiers
DOI: 10.1136/bmjopen-2021-050571
PMID: 34607865
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Large 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. Secondary 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. 39 public and private hospitals across India during the study period from 22 April to 14 July 2020. Of 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. Factors associated with all-cause mortality at 28 days after enrolment. The 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), PaO2/FiO2 ratio <100 (3.47, 1.64-7.37, p=0.001), neutrophil lymphocyte ratio >10 (9.97, 3.65-27.13, p<0.001), D-dimer >1.0 mg/L (2.50, 1.14-5.48, p=0.022), ferritin ≥500 ng/mL (2.67, 1.44-4.96, p=0.002) and lactate dehydrogenase ≥450 IU/L (2.96, 1.60-5.45, p=0.001) were significantly associated with death. In 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. CTRI/2020/04/024775. © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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