Factors associated with mortality among moderate and severe patients with COVID-19 in India: a secondary analysis of a randomised controlled trial

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 (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.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.

Blood phenotype O and indirect bilirubin are associated with lower, early COVID-19—related mortality: A retrospective study

“…Also, in line with our results, the study by Mammen et al, 27 reported that there was a statistically significant correlation between mortality and invasive ventilation, duration of invasive ventilation, and hospital stay as we found that there was a significantly higher in invasive mechanical ventilation (58% vs 0%) among died cases but noninvasive mechanical ventilation was significantly lower in non-survivors (41% vs 82%), p -value < .001.…”

Association of vasopressors with mortality in critically ill patients with COVID-19: A systematic review and meta-analysis

“…The studies originated from multiple countries, with 13 of coming from institutions located in the USA [20,21,23,[32][33][34][35]38,42,43,45,48,51]. Nineteen studies included only patients admitted in the ICU [20,22,24,25,27,[30][31][32][35][36][37][38][39][43][44][45][46][47]52], five studies included patients admitted in a COVID-19-dedicated HDU [28,29,33,34,42], eight studies included patients who were admitted in both HDU and ICU [21,23,26,40,41,48,49,51], and one study included Emergency Department patients who were later admitted either in the HDU of ICU [50]. Thirty studies included data about patients who received vs. patients who did not receive vasopressors…”

“…Twenty-one out of the 33 included studies provided data on hospital mortality in patients who received vs. patients who did not receive vasopressors, resulting in a total population of 7900 individuals [25,27,[31][32][33][34][35][36][37][39][40][41][42][43][44][45][46][47][48]50,52]. Due to high heterogeneity (I 2 : 94%, PQ<0.001), the random-effects model was implemented.…”

Biomarkers and Outcomes in Hospitalized Covid-19 Patients: A Prospective Registry

“…9 Limited studies have evaluated the prognostic biomarkers in developing countries where the burden of Covid-19 is the highest. 10 Only small studies are available from developing countries including India, [11][12][13][14][15][16][17] where the disease led to massive burden and deaths. Measurement of laboratory biomarkers is expensive and not routinely available in most developing countries.…”