Assessing of the Factors Associated with Mortality Among the Patients of PLACID Trial (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)

Abstract

Background: Large data on the clinical characteristics and outcome of COVID-19 in the Indian population are scarce. We analyzed the factors associated with mortality in a cohort of moderately ill COVID-19 patients enrolled in a multicentre randomized trial on convalescent plasma.Methods: Demographic, clinical, laboratory, treatment, and outcome data were extracted from electronic records. Factors associated with mortality were explored using univariate and multivariable Cox regression analysis and expressed as hazard ratio (HR) with 95% confidence intervals (CI).Findings: The mean (SD) age of the cohort (n=451) was 51±12·4 years; 76·7% were male. Admission SOFA 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 all-cause mortality was 14·4%. Median time from symptom onset to hospital admission was similar (p=1.0) in survivors (4 days; IQR 3-7) and non survivors (4 days; IQR 3-6). Patients with two or more co-morbidities had 2·25 (95%CI:1·17–4·32, p=0·014) times risk of death. When compared with survivors, admission IL-6 levels were higher (p2/FiO2 ratio10 (9·38, 3·67-24·0,p1·0mg/l (2·51,1·14-5·51,p=0·022), ferritin>500ng/ml (2·66,1·46-4·85,p=0·001) and LDH≥450 IU/L (2·96,1·61-5·45,p=0·001) were significantly associated with death.Interpretation: In this cohort of moderately ill COVID-19 patients, severity of illness, underlying co-morbidities and higher levels of inflammatory markers were significantly associated with death.Trial Registration: The trial protocol was registered with the Clinical Trial Registry of India (CTRI/2020/04/024775).Funding: This study was funded by Indian Council of Medical Research, an autonomous government funded medical research council.Declaration of Interests: No other author has any competing financial or non-financial interest.Ethics Approval Statement: Ethical approval was obtained from the ICMR Central Ethics Committee on Human Research 326 (CECHR-002/2020) as well as from the Institutional Review Boards (IRB) /Institutional Ethics 327 Committees of all the participating hospitals.