Outcomes among 10,314 hospitalized COVID‐19 patients at a tertiary care government hospital in Delhi, India

Malhotra, Vikas; Basu, Saurav; Sharma, Nandini; Kumar, Suresh; Garg, Sandeep; Dushyant, Kumar; Borle, Amod

doi:10.1002/jmv.26956

Cited by 23 publications

(19 citation statements)

References 13 publications

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“…Table 5). [26][27][28][29][30][31] Mortality at 1-month has been observed to be 19.4%, 35% and 15.2% in the control-arms and 19.7%, 31% and 11.4% in the treatment-arms of the COVACTA, RECOVERY (Tocilizumab) and ACTT-1 trials, respectively. 24,25,32 A lower percentage of patients received systemic corticosteroids in the COVACTA (tocilizumab, 33.7%; control, 52.1%) and ACTT-1 (Remdesivir, 21.6%; control, 24.4%) trials though a higher proportion of patients received steroids in the RECOVERY trial (tocilizumab, 82%; control, 82%) and in the current study (Itolizumab, 85.3%).…”

Section: Discussionmentioning

confidence: 99%

“…Itolizumab's intervention, thus, can be helpful before the patient progresses to severe ARDS requiring IMV. Median time to recovery with Itolizumab was 8 (7-10) days and it was 10 (9-11) days with Remdesivir in the ACTT-1 trial, 20 (17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27) days with Tocilizumab in the COVACTA trial and 19 days with Tocilizumab in the RECOVERY trial. 24,25,32 Taken together, the mortality, recovery, and remission observations with Itolizumab suggest a survival as well as an early recovery benefit.…”

Section: Discussionmentioning

confidence: 99%

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REcovery and SURvival of patients with moderate to severe acute REspiratory distress syndrome (ARDS) due to COVID-19: a multicentre, single-arm, Phase IV Itolizumab Trial: RESURRECT

Raveendra

Rathod²,

Darnule³

et al. 2021

Preprint

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Objective: To evaluate safety and efficacy of Itolizumab in hospitalized COVID-19 patients with PaO2/FiO2 ratio (PFR) ≤200 requiring oxygen therapy. Design: A multicentre, single-arm, Phase-4 study with a treatment period of 30-Days and an extended follow-up period of 90-Days. Methods: Hospitalized adult patients (n=300) with SARS-CoV-2 infection, with PFR ≤200, oxygen saturation ≤94% and ≥1 elevated inflammatory markers were included from 17 COVID-19 specific tertiary hospitals in India. Patients received Itolizumab infusion 1.6 mg/kg and were assessed for 1-month and then followed up to Day-90. Results: Day-30 post-treatment safety/efficacy results and Day-90 mortality results are presented. Primary outcome measures: incidence of severe acute infusion-related reactions (IRRs) (≥Grade-3) was 1.3% and mortality rate at 1-month was 6.7% (n=20/300). Key secondary analyses: Mortality rate at Day-90 was 8.0% (24/300). 91.7% patients came off the oxygen therapy within Day-30 of treatment. By Day-7, most patients had stable/improved SpO2 without increasing FiO2. Mean PFR improved by 50% by Day-7 (p<0.001) and the trend remained consistent till Day-30. Median time of recovery was 8 days. Cumulatively, at Day-30, 260(86.7%), 256(85.3%), 132(44.0%), 113(37.6%) and 32(10.7%) patients showed >1-point, >2-point, >3-point, >4-point and 5-point improvement on the modified COVID-19 8-point ordinal scale and worsening of symptoms by >1 point, >2 points and 3-points was seen in 26(8.7%), 20(6.7%) and 6(2.0%) patients, respectively. CRP, D-dimer, LDH and serum ferritin levels significantly decreased (p≤0.01) compared with baseline. IL-6 and TNFα levels also decreased 48-hours post-infusion. Overall, 123 treatment-emergent adverse events (TEAEs) were reported in 63 patients, most being Grades 1-3. Most common TEAEs were IRRs and lymphopenia; most common serious TEAEs were septic shock, worsening of ARDS and respiratory failure. No deaths were attributable to Itolizumab. Conclusion: Itolizumab shows no new safety concerns and suggests a mortality and recovery benefit at 1-month in hospitalized COVID-19 patients requiring oxygen therapy.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

REcovery and SURvival of patients with moderate to severe acute REspiratory distress syndrome (ARDS) due to COVID-19: a multicentre, single-arm, Phase IV Itolizumab Trial: RESURRECT

Raveendra

Rathod²,

Darnule³

et al. 2021

Preprint

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“…This was a prospective observational cohort study of healthcare workers (HCWs) working in a dedicated 2200-bedded COVID-19 Care Centre in a metro city, which has managed over 20,000 moderate-to-severe COVID-19 cases since April 2020 [ 17 ]. The data were collected from 2 December 2020 to 25 May 2021.…”

Section: Methodsmentioning

confidence: 99%

Seroprevalence of SARS-CoV-2 and Risk Assessment Among Healthcare Workers at a Dedicated Tertiary Care COVID-19 Hospital in Delhi, India: A Cohort Study

Sharma¹,

Chawla²,

Basu³

et al. 2021

Cureus

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BackgroundHealthcare workers (HCWs) have a substantially higher risk of Covid-19 infection but there is a paucity of information on the risk factors of disease transmission in high-burden real-world settings.The study objective was to determine the seroprevalence of SARS-CoV-2 among healthcare workers in a high-burden Covid-19 setting and to estimate the incidence and identify the risk factors of infection. MethodsThis was a prospective observational cohort study amongst doctors and nurses working at a dedicated Covid-19 tertiary care government hospital in Delhi, India. A baseline blood sample (2-3ml) was collected from all the participants to test for the presence of total SARS-CoV-2 antibodies. The HCWs that were seronegative (non-reactive) at baseline were followed-up for ≥21≤28 days with the collection of a second blood sample to assess for the incidence of SARS-CoV-2 infection. ResultsA total of 321 (51.3%, 95% C.I 47.4, 55.3) HCWs were detected with SARS-CoV-2 antibodies on baseline examination. The seroprevalence, when adjusted for assay characteristics, was 54.5% (95% C.I 50.3, 58.6). On bivariate analysis, SARS-CoV-2 antibody positivity lacked statistically significant association with either age, sex, occupation, cumulative duty duration, and smoking status. The incidence of seroconversion in the baseline seronegative cohort on follow-up after 21-28 days was observed in 35 (14.9%) HCWs (n=245). Furthermore, the self-reported adherence to infection prevention and control measures did not show a statistically significant association with antibody positivity in the HCWs, neither at baseline nor on followup. ConclusionsThe high risk of SARS-CoV-2 transmission in HCWs may be substantially reduced by adherence to Infection Prevention Control (IPC) and protective measures.

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“…Standard of care was based on the recommendations of the Indian Council of Medical Research, which was updated as per the evolving evidence generated in drug trials and international consensus guidelines. 23,24 Overall, it included antibiotic agents, antiviral agents, corticosteroids, vasopressor support, and anticoagulants at the discretion of the clinicians.…”

Section: Standard Of Carementioning

confidence: 99%

Effect of Adjunct Tele-Yoga on Clinical Status at 14 Days in Hospitalized mild and Moderate COVID-19 Patients: a Randomized Controlled Trial

Majumdar

Nagarathna

Panigrahi

et al. 2022

Preprint

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Background: We tested if tele-yoga intervention could aid in better clinical management for hospitalized patients with mild to moderate COVID-19 when complemented with the standard of care.Methods: This was a randomized controlled trial conducted at the Narayana Hrudalaya, Bengaluru, India on hospitalized patients with mild to moderate COVID-19 infection, enrolled between May 31st and July 22, 2021. Patients (n=225) were randomized in 1:1 ratio [adjunct tele-yoga (n = 113), or standard of care (n = 112)]. Adjunct yoga group received intervention in tele-mode within 4 hours post-randomization until 14 days along with the standard of care. The primary outcome was clinical status at 14th-day post-randomization assessed with a 7-category ordinal scale. The trial included 11 secondary outcomes, including 28-day mortality.Results: As compared with standard of care alone, the proportional odds of having a higher score on the seven-point ordinal scale at day 14 was ~1.9 for the adjunct tele-yoga group (95% CI, 1.18-3.18). CRP and LDH levels were comparatively reduced in the adjunct tele-yoga group 5th day post-randomization. CRP reduction was also observed as a potential mediator for the improvement of clinical outcomes in the adjunct tele-yoga group. There were no significant differences between the treatment groups concerning the duration of hospitalization, all-cause mortality at day 28; log-rank P = 0.144, and other outcomes.Conclusion: The observed clinically relevant outcomes in COVID-19 patients at day 14 contest the use of tele-yoga as a complementary treatment in hospital settings.

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Outcomes among 10,314 hospitalized COVID‐19 patients at a tertiary care government hospital in Delhi, India

Cited by 23 publications

References 13 publications

REcovery and SURvival of patients with moderate to severe acute REspiratory distress syndrome (ARDS) due to COVID-19: a multicentre, single-arm, Phase IV Itolizumab Trial: RESURRECT

REcovery and SURvival of patients with moderate to severe acute REspiratory distress syndrome (ARDS) due to COVID-19: a multicentre, single-arm, Phase IV Itolizumab Trial: RESURRECT

Seroprevalence of SARS-CoV-2 and Risk Assessment Among Healthcare Workers at a Dedicated Tertiary Care COVID-19 Hospital in Delhi, India: A Cohort Study

Effect of Adjunct Tele-Yoga on Clinical Status at 14 Days in Hospitalized mild and Moderate COVID-19 Patients: a Randomized Controlled Trial

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