1. Factors associated with mortality among moderate and severe patients with COVID-19 in India: a secondary analysis of a randomised controlled trial
- Author
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Yojana A Gokhale, B Thrilok Chander, Amit Suri, Pragya D Yadav, Ravindraa Singh, Anand Zachariah, M Natarajan, Nimisha Sharma, Irfan Nagori, Kamlesh Upadhyay, Sunil J Panjwani, Vrushali Khirid Khadke, Pranab Chatterjee, Jayashree Sharma, Sunita Bundas, Ravi Dosi, Anil Gurtoo, Shalini Bahadur, Ram S Kaulgud, Snehil Kumar, Malathi Murugesan, Vivek Kumar, V Saravana Kumar, Simmi Dube, Himanshu Kaushal, Seema Dua, Rosemarie de Souza, C Aparna, Ashish Jain, Tarun Bhatnagar, John Victor Peter, KV Sreedhar Babu, Om Shrivastav, Binila Chacko, Vijay Barge, B Latha, Aikaj Jindal, Pramod R Jha, Shreepad Bhat, Ashish Sharma, Anup Agarwal, Gunjan Kumar, Lovely Thomas, Lakshmanan Jeyaseelan, Melvin Joy, Neha Singh, Gajanan N. Sapkal, D. Himanshu Reddy, Dolly Daniel, Muralidhar Tambe, Jess Elizabeth Rasalam, Aparna Mukherjee, Archana Bajpayee, Tinkal C Patel, Pankaj Malhotra, Priscilla Rupali, Milind Baldi, Janakkumar R Khambholja, Thenmozhi Mani, and Joy John Mammen
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Adult ,medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,India ,Disease ,law.invention ,Randomized controlled trial ,law ,Secondary analysis ,Internal medicine ,Severity of illness ,Humans ,Medicine ,adult intensive & critical care ,COVID-19 Serotherapy ,SARS-CoV-2 ,business.industry ,Public health ,Immunization, Passive ,COVID-19 ,General Medicine ,Middle Aged ,Cohort ,Breathing ,Public Health ,business - 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 measureFactors 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 (p2/FiO2 ratio 10 (9.97, 3.65–27.13, p1.0 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.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 numberCTRI/2020/04/024775.
- Published
- 2021