Remdesivir (Retros)
Evaluation of Safety and Effectiveness of Remdesivir in Treating COVID-19 Patients After EUA (Emergency Use Authorization)
Abstract
Association between cardiovascular diseases and COVID-19 pneumonia outcome in Indonesia:
a multi-center cohort study
COVID-19 is a pandemic affecting 185 countries, including Indonesia. Cardiovascular diseases (CVD) in COVID-19 patients were linked to worse clinical outcomes. However, the association remained inconclusive due to limited data in Indonesia. This study aimed to determine the association between CVD in COVID-19 pneumonia patients with its clinical outcomes.
This retrospective cohort study was conducted in four Indonesian hospitals, enrolling 584 adult COVID-19 pneumonia patients from September 2020 to July 2021. Patients were categorized into two groups: non-CVD and CVD [hypertension, coronary artery disease (CAD), chronic heart failure (CHF), hypertensive heart disease (HHD), arrhythmia, cardiomegaly, left ventricular hypertrophy (LVH), mitral regurgitation (MR), and myocardial injury (MI)]. Clinical outcomes include in-hospital mortality, intensive care unit admission, ventilator use, earlier death, and prolonged hospital stay. Mann-Whitney test was used for analysis.
The most common CVD was hypertension (48.1%), followed by MI (10.6%), CAD (9.2%), CHF (6.8%), HHD (3.1%), arrhythmia (1.7%), and others (0.7%). The in-hospital mortality rate was 24%, and patients were hospitalized for a median of 12 days. MI was the only CVD that increased in-hospital mortality (RR 2.105). It was also significantly increased in patients with diabetes mellitus (RR 1.475) and chronic kidney disease (RR 2.079). Meanwhile, prolonged hospital stay was associated with any CVD (RR 1.553), hypertension (RR 1.511), MI (RR 1.969), CHF (RR 1.595), diabetes mellitus (RR 1.359), and cerebrovascular disease (RR 2.203).
COVID-19 pneumonia in patients with CVD, specifically MI and hypertension, worsens the COVID-19 clinical outcomes.
Information
This is a multicentered cohort retrospective study from medical records of COVID-19 patients with moderate to severe degree in Persahabatan Central General Hospital, Islam Cempaka Putih Hospital, Yarsi Hospital, Cengkareng District Hospital. The study objectives are to determine the safety of Remdesivir by determining the proportion of patients with at least one adverse event (AE) which is classified as incident with Adverse Event Special Interest (AESI), the proportion patients with each AESI and proportion of Serious Adverse Event (SAE) and to determine effectiveness of remdesivir by determining the proportion of patients who experienced clinical improvement and the proportion of patients who died within 2-4 weeks after drug administration. This study enrolled 587 subjects. This study is in collaboration with BPOM Indonesia and Amarox Pharmacy.
Type of Study
Topic
Collaborator
Observational Study
COVID-19
BPOM RI dan Amarox
Abstract
Evaluation of safety and effectiveness of remdesivir in treating COVID-19 patients after emergency use authorization study
This study aimed to determine the real-world safety and effectiveness of remdesivir in hospitalized adult COVID-19 patients with moderate-to-critical disease in Indonesia.
A multicenter, retrospective cohort study was conducted at four COVID-19 referral hospitals in Jakarta. A total of 587 patients were included, of whom 243 received remdesivir within 72 h of admission. The safety endpoints were the proportions of patients with any adverse event (AE), any grade 3 AE, and AE of each system organ class. The effectiveness endpoints were ICU admission >24 h from baseline, live discharge and mortality at day 14, live discharge and mortality at day 28, and virologic conversion. Patients who received remdesivir within 72 h of admission were considered the treatment group, and those who did not were the control group. Multivariate adjustments were performed using a modified Poisson regression.
The study found no significant differences in safety endpoints between the two groups. However, the effectiveness endpoints showed that remdesivir was associated with a decreased risk of ICU admission >24 h from baseline (RR 0.71, 95% CI 0.52-0.96), an increased probability of live discharge at day 14 (RR 1.37, 95% CI 1.08-1.74), and an increased probability of live discharge at day 28 (RR 1.28, 95% CI 1.05-1.57). The rate of virologic conversion was not significantly different between the two groups.
The study concludes that remdesivir is safe and effective in the treatment of moderate-to-critical COVID-19 in a real-world setting in Indonesia.
