Clinical outcomes of using remdesivir in patients with moderate to severe COVID-19

Abstract

Background and Aims: When the world was frantically searching for a drug effective against the coronavirus disease (COVID)-19, remdesivir, a broad-spectrum anti-viral medication, became a part of the COVID treatment. We planned a study to evaluate improvement in clinical outcomes with remdesivir treatment for five days. Methods: Participants more than 40-years old and with moderate to severe COVID-19 but not on mechanical ventilation were randomly assigned into two groups-remdesivir group (34 cases) to receive the study drug intravenous (IV) remdesivir for five days plus the standard care (SC) and non-remdesivir group (36 cases) to receive the SC but not to receive the study drug. Follow-up was continued for 12 days after the beginning of treatment or until discharge/death. Patient's clinical status was assessed by laboratory investigations and physical examination (from day 1 to day 12 on a 4-point ordinal scale and from day 12 to 24 on a 6-point ordinal scale). Oxygen support requirements and adverse events were recorded. The data were entered and analysed using Statistical Package for the Social Sciences (SPSS) version 22.0. Results: High-flow oxygen support and non-invasive ventilation was required at baseline by lesser patients in the remdesivir group. In the end, both groups had similar outcomes after adjustment for baseline clinical status. There was no statistical difference in mortality between the two groups (p = 0.749). Patients in both groups had an equal time to recovery. There was no difference in the occurrence of adverse effects of remdesivir between the two groups. Conclusion: Remdesivir therapy for five days did not produce improvement in clinical outcomes in moderate to severe COVID-19 cases.

Evidence of the Clinical Efficacy of Antiviral Agents against SARS-CoV-2

“…The WHO's pivotal SOLIDARITY trial (n= 2 743) found that RDV treatment had no real effects on mortality or the course of the disease and did not show overall efficacy [24]. This study, supported by two other smaller studies, including a nor-solidarity trial, provided sufficient evidence to conclude that RDV has little efficacy to offer [22,23]. Some improvement was seen when combining RDV with barcitinab, but this was not convincing [21].…”

“…Eight RCTs, including the WHO's SOLIDARITY trial, involving a total of 4 829 patients, have tested the efficacy of RDV (Table 1). Early studies, [17][18][19][20] showed promising results while later larger trials, [21][22][23][24] disputed these findings. Initial trials indicated that RDV showed potential, most notably in studies conducted by Wang et al and Beigel et al [17,18].…”

Characteristics of published/registered clinical trials on COVID-19 treatment: A systematic review

“…The RCT has been conducted by The Adaptive COVID-19 Treatment Trial (ACTT) showed shortened duration of disease course and mortality reduction in patients who needed supplemental oxygen [23]. Conversely, another large international, multi-arm, RCT named "Solidarity" [24] and other RCTs [25,26] has not reported an overall reduction in mortality of COVID-19 hospitalized patients who received remdesivir. Overall, Solidarity has not reported mortality benefit, shortened time to discharge or ventilation requirement reduction following the administration of remdesivir.…”

Update Alert: Should Remdesivir Be Used for the Treatment of Patients With COVID-19? Rapid, Living Practice Points From the American College of Physicians (Version 2)

“…The living, rapid systematic review identified 1 new randomized controlled trial that met inclusion criteria, comparing a 5-day course of remdesivir to standard care in adults hospitalized with COVID-19 not requiring invasive ventilation at baseline (5). The new study, however, was determined to be of poor quality (high risk of bias).…”

“…This is an update of the American College of Physicians' living, rapid practice points about using remdesivir for treatment of COVID-19 (1), which is based on an updated systematic review done through 10 May 2021 (2)(3)(4). The evidence update identified 1 new study that could inform Practice Point 1 (5). No new studies were identified as supporting evidence for Practice Points 2 or 3.…”