BMJ Open (Oct 2021)

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

  • Ashish Sharma,
  • Anand Zachariah,
  • Pankaj Malhotra,
  • Ashish Jain,
  • Priscilla Rupali,
  • Gajanan Sapkal,
  • Aparna Mukherjee,
  • Vivek Kumar,
  • Lakshmanan Jeyaseelan,
  • Neha Singh,
  • John Victor Peter,
  • Anup Agarwal,
  • Gunjan Kumar,
  • Pranab Chatterjee,
  • Tarun Bhatnagar,
  • B Latha,
  • Sunita Bundas,
  • Ravi Dosi,
  • Rosemarie de Souza,
  • Simmi Dube,
  • B Thrilok Chander,
  • Shalini Bahadur,
  • Amit Suri,
  • Aikaj Jindal,
  • Om Shrivastav,
  • Vijay Barge,
  • Archana Bajpayee,
  • Muralidhar Tambe,
  • Nimisha Sharma,
  • Shreepad Bhat,
  • Anil Gurtoo,
  • D Himanshu Reddy,
  • Kamlesh Upadhyay,
  • Tinkal C Patel,
  • Irfan Nagori,
  • Pramod R Jha,
  • C Aparna,
  • Sunil Jodharam Panjwani,
  • Milind Baldi,
  • M Natarajan,
  • Vrushali Khirid Khadke,
  • Seema Dua,
  • Joy John Mammen,
  • Snehil Kumar,
  • Dolly Daniel,
  • Ravindraa Singh,
  • Jayashree Sharma,
  • Yojana A Gokhale,
  • V Saravana Kumar,
  • Himanshu Kaushal,
  • Lovely Thomas,
  • Jess Elizabeth Rasalam,
  • Binila Chacko,
  • Thenmozhi Mani,
  • Melvin Joy,
  • Malathi Murugesan,
  • Janakkumar R Khambholja,
  • Ram S Kaulgud,
  • K V Sreedhar Babu,
  • Pragya D Yadav

DOI
https://doi.org/10.1136/bmjopen-2021-050571
Journal volume & issue
Vol. 11, no. 10

Abstract

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Objective 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.Design 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.Setting 39 public and private hospitals across India during the study period from 22 April to 14 July 2020.Participants 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.Primary outcome measure Factors associated with all-cause mortality at 28 days after enrolment.Results 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.Conclusion 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.Trial registration number CTRI/2020/04/024775.