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 John , Kumar Snehil , Thomas Lovely , Kumar Gunjan , Zachariah Anand , Jeyaseelan Lakshmanan , Peter John Victor , Agarwal Anup , Mukherjee Aparna , Chatterjee Pranab , Bhatnagar Tarun , Rasalam Jess Elizabeth , Chacko Binila , Mani Thenmozhi , Joy Melvin , Rupali Priscilla , Murugesan Malathi , Daniel Dolly , Latha B , Bundas Sunita , Kumar Vivek , Dosi Ravi , Khambholja Janakkumar R , de Souza Rosemarie , Chander B Thrilok , Bahadur Shalini , Dube Simmi , Suri Amit , Jindal Aikaj , Shrivastav Om , Barge Vijay , Bajpayee Archana , Malhotra Pankaj , Singh Neha , Tambe Muralidhar , Sharma Nimisha , Bhat Shreepad , Kaulgud Ram S , Gurtoo Anil , Reddy D Himanshu , Upadhyay Kamlesh , Jain Ashish , Patel Tinkal C , Nagori Irfan , Jha Pramod R , Babu K V Sreedhar , Aparna C , Panjwani Sunil Jodharam , Natarajan M , Baldi Milind , Khadke Vrushali Khirid , Dua Seema , Singh Ravindraa , Sharma Ashish , Sharma Jayashree , Gokhale Yojana A , Yadav Pragya D , Sapkal Gajanan , Kaushal Himanshu , Kumar V Saravana 
Published: October 2021

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/FiO2ratio <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.