Safety and Efficacy of Remdesivir for the Treatment of Covid-19: A Rapid  Review of Available Evidence

Zahra   Gharibnaseri; Alireza  Olyaeemanesh

doi:10.18502/htaa.v4i1.5863

Zahra Gharibnaseri National Institute of Health Research, Payment and Financial Resources of the Health System Department, Tehran University of Medical Sciences, Tehran, Iran
Alireza Olyaeemanesh National Institute of Health Research, Payment and Financial Resources of the Health System Department, Tehran University of Medical Sciences, Tehran, Iran

DOI: https://doi.org/10.18502/htaa.v4i1.5863

Keywords: Covid-19; Corona Virus; Remdesivir

Abstract

Context: Remdesivir is an antiviral drug manufactured by Gilead Sciences, Inc., in which in-vitro studies have been shown to work in COVID-19 patients. Although it’s not approved by pharmaceutical authorities and has not passed the first and second phases of clinical trials, it is prescribed on a trial basis for patients with Covid-19. In more than 20 countries, researchers are monitoring the results of using Remdesivir in clinical settings to see if it can be prescribed for larger populations if patients respond positively.

Methods: This is a rapid review of the evidence for the potential effects of Remdesivir, which intended to create a policy guide. To do so, health technology assessment studies indexed in MEDLINE and Cochrane Library databases were searched using the keywords, including drug name and disease name, on April 21, 2020. In addition, references of retrieved studies were checked to ensure throughout the capture of the literature. Studies on the safety and efficacy of Remdesivir in Covid-19 patients, both in Persian or English, were included. To identify ongoing clinical trials in Iran and some countries, clinical trial registration systems were also searched.

Results: In total 90 titles were identified, which after removing duplicates and applying inclusion criteria, 32 were included, all of which were published in 2020. 25 of them were review studies, mostly on treating Covid-19 disease, and some of them were dedicated to the effects of Remdesivir in treating the disease. However, no systematic review was found. Of the remaining studies, three were finished clinical trials, two of which evaluated the safety and efficacy of Remdesivir on mild, moderate, and severe Covid-19 compared to a placebo, and the third study compared Remdesivir with routine treatment. A cohort study on the efficacy of Remdesivir in compassionate use was also found. Also, two case reports of patients receiving Remdesivir and a letter-to- editor describing Remdesivir as an appropriate treatment for Covid-19 were identified. Moreover, registered clinical trials with different designs intended to investigate the safety and efficacy of Remdesivir in treating Covid-19 were extracted from clinical trial registration systems (Table 3). In total 15 protocols were found, which 13 were in primary stages. The other two were in phase three of clinical trials and aimed to investigate the effect of Remdesivir in treating patients with severe, moderate, or mild Covid-19. In the clinical trial registration system, it is mentioned that the first study is stopped prematurely due to the lack of a sufficient number of patients, and the second study is also suspended.

Conclusions: Evidence on the safety and efficacy of Remdesivir in treating Covid-19 are very limited to make a decision. However, if registered trials are completed, enough evidence would be available to decide whether to accept or reject the Remdesivir. Since the effectiveness of Remdesivir is not clear yet, its prescription for Covid-19 patients has so far been limited to clinical trials, compassionate use, or emergency use.