Study of Efficacy of Injection Remdesivir in Patients of COVID-19

The coronavirus disease of 2019 (COVID-19) is a highly contagious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). World Health Organization (WHO) declared it a pandemic on 11th March 2020. Injectable remdesivir (RDV), a repurposed antiviral, was first accorded approval by the United States of America (USA) Food and Drug Administration (FDA) on 1st May 2020, for emergency use to treat suspected or laboratory-confirmed COVID-19 patients. Interim analysis of the Solidarity trial revealed no benefits in patients treated with RDV in any group of patients with COVID-19. Here, we have attempted to place our data on the efficacy of RDV in patients of COVID-19 with moderate to severe categories.

A retrospective review and data analysis of 100 COVID-19 patients with reverse transcriptase polymerase chain reaction (RT-PCR)/rapid antigen test positive was performed. Among them, 50 received RDV in addition to the standard treatment protocol (STP), while the remaining 50 received only the STP. STP is an injectable steroid and heparin, along with other supportive management. Prevalent government guidelines were followed as per usual for the classification of the patients and treatment protocol. Every day of hospitalization, the status of respiratory support was checked, and every 3rd-day inflammatory markers [C-reactive protein (CRP) and D-dimer] were measured until the patient was discharged or died. Statistical analysis of the data was done using online software.

Age and comorbidity distribution in both groups ensures adequate matching between the two groups. A statistically significant difference in hospitalization days was obtained in RDV-treated patients (15 vs 19 days, p-value -0.003). Statistically significant differences were not found in mortality (6 vs 10 deaths, p-value -0.27) and reduction in oxygen (O2)/ventilatory support requirements (p-value -0.75) in the RDV group as compared to other groups. The difference in the value of CRP (p-value 0.001) and D-dimer (p-value 0.049) on day 5 is statistically significant in the RDV group as compared to the other groups.

The finding of a reduction in days of hospitalization was similar to the Adaptive COVID-19 Treatment Trial (ACTT) 1 study conducted by Beigel et al. The mortality data were also comparable to those from WHO's Solidarity trial. No similarity was found in data on the reduction in ordinal scale from higher to lower scale for O2/ventilatory support on day 10 from 0. Similarity regarding the reduction in values of inflammatory markers on day 5 was found in studies conducted by Kannan et al. and Stoeckle et al.

We found mortality benefit and reduction in O2 requirements/ventilatory support in RDV plus STP-administered cases as compared to STP only, but statistically, this difference is not significant, which suggests that mortality benefit in the RDV group in our study is merely by chance. Here, we can definitely conclude that days of hospital stay and inflammatory markers are reduced in the RDV plus STP-administered group, and the difference between the two groups is statistically significant, which suggests that early use of RDV could shorten the time to clinical improvement.