Browse by author
Lookup NU author(s): Melvin JoyORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 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.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), PaO 2 /FiO 2 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.
Author(s): Mammen JJ, Kumar S, Thomas L, Kumar G, Zachariah A, Jeyaseelan L, Peter JV, Agarwal A, Mukherjee A, Chatterjee P, Bhatnagar T, Rasalam JE, Chacko B, Mani T, Joy M, Rupali P, Murugesan M, Daniel D, Latha B, Bundas S, Kumar V, Dosi R, Khambholja JR, De Souza R, Chander BT, Bahadur S, Dube S, Suri A, Jindal A, Shrivastav O, Barge V, Bajpayee A, Malhotra P, Singh N, Tambe M, Sharma N, Bhat S, Kaulgud RS, Gurtoo A, Reddy DH, Upadhyay K, Jain A, Patel TC, Nagori I, Jha PR, Babu KVS, Aparna C, Panjwani SJ, Natarajan M, Baldi M, Khadke VK, Dua S, Singh R, Sharma A, Sharma J, Gokhale YA, Yadav PD, Sapkal G, Kaushal H, Kumar VS
Publication type: Article
Publication status: Published
Journal: BMJ Open
Year: 2021
Volume: 11
Issue: 10
Print publication date: 04/10/2021
Online publication date: 04/10/2021
Acceptance date: 08/09/2021
Date deposited: 28/07/2023
ISSN (print): 2044-6055
ISSN (electronic): 2044-6055
Publisher: BMJ Publishing Group
URL: http://dx.doi.org/10.1136/bmjopen-2021-050571
DOI: 10.1136/bmjopen-2021-050571
PubMed id: 34607865
Altmetrics provided by Altmetric
