TY - JOUR T1 - Factors associated with mortality among moderate and severe patients with COVID-19 in India: a secondary analysis of a randomised controlled trial JF - BMJ Open JO - BMJ Open DO - 10.1136/bmjopen-2021-050571 VL - 11 IS - 10 SP - e050571 AU - Joy John Mammen AU - Snehil Kumar AU - Lovely Thomas AU - Gunjan Kumar AU - Anand Zachariah AU - Lakshmanan Jeyaseelan AU - John Victor Peter AU - Anup Agarwal AU - Aparna Mukherjee AU - Pranab Chatterjee AU - Tarun Bhatnagar AU - Jess Elizabeth Rasalam AU - Binila Chacko AU - Thenmozhi Mani AU - Melvin Joy AU - Priscilla Rupali AU - Malathi Murugesan AU - Dolly Daniel AU - B Latha AU - Sunita Bundas AU - Vivek Kumar AU - Ravi Dosi AU - Janakkumar R Khambholja AU - Rosemarie de Souza AU - B Thrilok Chander AU - Shalini Bahadur AU - Simmi Dube AU - Amit Suri AU - Aikaj Jindal AU - Om Shrivastav AU - Vijay Barge AU - Archana Bajpayee AU - Pankaj Malhotra AU - Neha Singh AU - Muralidhar Tambe AU - Nimisha Sharma AU - Shreepad Bhat AU - Ram S Kaulgud AU - Anil Gurtoo AU - D Himanshu Reddy AU - Kamlesh Upadhyay AU - Ashish Jain AU - Tinkal C Patel AU - Irfan Nagori AU - Pramod R Jha AU - K V Sreedhar Babu AU - C Aparna AU - Sunil Jodharam Panjwani AU - M Natarajan AU - Milind Baldi AU - Vrushali Khirid Khadke AU - Seema Dua AU - Ravindraa Singh AU - Ashish Sharma AU - Jayashree Sharma AU - Yojana A Gokhale AU - Pragya D Yadav AU - Gajanan Sapkal AU - Himanshu Kaushal AU - V Saravana Kumar Y1 - 2021/10/01 UR - http://bmjopen.bmj.com/content/11/10/e050571.abstract N2 - 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.Data are available upon reasonable request. Data will be made available, upon request, and must be accompanied by a brief proposal outlining the analysis plan. A signed data access agreement might be needed to ensure data safety and compliance with national rules about data sharing. ER -