A Retrospective Observational Study of Hypoxic COVID-19 Patients Treated with Immunomodulatory Drugs in a Tertiary Care Hospital
Mahale et al.,
A Retrospective Observational Study of Hypoxic COVID-19 Patients Treated with Immunomodulatory Drugs in a..,
Indian Journal of Critical Care Medicine, doi:10.5005/jp-journals-10071-23599
Retrospective 134 hospitalized COVID-19 patients in India, showing no significant difference with HCQ treatment in unadjusted results.
Although the 29% lower mortality is not statistically significant, it is consistent with the significant 22% lower mortality
[18‑27%] from meta analysis of the
232 mortality results to date.
This study is excluded in the after exclusion results of meta
analysis:
unadjusted results with no group details.
risk of death, 28.7% lower, RR 0.71, p = 0.36, treatment 25 of 102 (24.5%), control 11 of 32 (34.4%), NNT 10.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Mahale et al., 31 Dec 2020, retrospective, India, peer-reviewed, 22 authors, study period 22 March, 2020 - 21 May, 2020.
Abstract: RESEARCH ARTICLE
A Retrospective Observational Study of Hypoxic COVID-19
Patients Treated with Immunomodulatory Drugs in a Tertiary
Care Hospital
Nilesh Mahale1, Prasad Rajhans2, Purushotham Godavarthy3, Vikram L Narasimhan4, Gauri Oak5, Srinath Marreddy6,
Amruta Bedekar7, Ujwal Dhundi8, Harshwardhan S Pawar9, Prasad Akole10, Balasaheb Pawar11, Bhagyashri Bhurke12,
Shailaja Chavan13, Parikshit Prayag14, Bharat Purandare15, Pradip Dalvi16, Vishnu Telbhare17, Prasanna Marudwar18,
Dnyaneshwar Diwane19, Manasi Shahane20, Amrita Prayag21, Shradha Gugale22, Shreyas Bhor23, Sameer Jog24
A b s t r ac t
Objectives: To describe the demographics and evaluate the clinical outcomes of hypoxic coronavirus disease-2019 (COVID-19) patients treated
with different immunomodulatory (IM) drugs in a resource-limited setting.
Materials and methods: We conducted a retrospective cohort study of these patients admitted to our hospital between March 22 and May 31,
2020. Data were abstracted from multiple electronic data sources or patient charts to provide information on patient characteristics, clinical,
laboratory variables, and outcomes.
Results: A total of 134 patients met the inclusion criteria and were followed up till June 7, 2020. The median age of the patients was 55.6 years
(range 20–89 years) and 68% were men. At least one comorbidity was seen in 72% of the patients with diabetes (44%) and hypertension (46%)
being the most common. At triage, fever (82%), shortness of breath (77%), and cough (61%) were the most common presenting symptoms. A
PaO2/FiO2 ratio less than 300 was seen in 60%, and 4.5% required invasive mechanical ventilation within 72 hours of hospital admission. Five
immunomodulatory agents (hydroxychloroquine, methylprednisolone, colchicine, etoricoxib, and tocilizumab) were administered in different
combinations. Overall, in-hospital mortality was 26.9%, and 32% required mechanical ventilation. Around 69% of patients were discharged
home. Five variables (SpO2, PaO2/FiO2 ratio, leukocytosis, lymphopenia, and creatinine) on admission were found to be significant in the patients
who died.
Conclusion: Our study provides the characteristics and outcomes of hypoxic COVID-19 patients treated with IM drugs in varied combination.
Five independent variables were strong predictors of mortality.
Keywords: Acute respiratory distress syndrome, Coronavirus disease-2019, Immunomodulatory drugs, Resource-limited settings.
Indian Journal of Critical Care Medicine (2020): 10.5005/jp-journals-10071-23599
I n t r o d u c t i o n
India reported the first case of coronavirus disease-2019 (COVID19) on January 30, 2020.1 The World Health Organization (WHO)
declared COVID-19 as pandemic on March 11, 2020, and our hospital
admitted the first COVID patient on March 22. Though the exact
pathogenesis of severe acute respiratory syndrome-coronavirus-2
(SARS CoV-2) is unknown, various hypotheses have proposed
cytokine storm or hyperinflammatory syndrome as probable causes
for rapid worsening of the disease. To date, there is no evidence that
any potential therapy improves outcomes in patients with COVID192–4 and various antiviral and immunomodulatory (IM) drugs have
been repurposed for the treatment of COVID-19.
Currently, there is no published data about baseline characteristics,
clinical features, and outcomes from India. Considering the impact
the disease has on the public health especially in a resource-limited
country like ours, we conducted a retrospective..
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