Evaluating the Therapeutic Effect of Remdesivir on COVID-19 Patients: A Single-Arm and Non-randomized Clinical Trial
| Author | Roohangize Nashibi | en |
| Author | Fatemeh Ahmadi | en |
| Author | Fatemeh Amini | en |
| Author | Mehrdad Dargahi | en |
| Author | Ramin Jamshididan | en |
| Author | Hanieh Raji | en |
| Author | Maryam Haddad Zade Shooshtari | en |
| Author | Khojasteh Hoseinynejad | en |
| Author | Farid Yousefi | en |
| Author | Vahid Garmsiri | en |
| Author | Farhad Soltani | en |
| Author | Gholamreza Alizade Attar | en |
| Author | Seyed Mohammad Alavi | en |
| Author | Mehran Varnasseri | en |
| Orcid | Roohangize Nashibi [0000-0002-5411-9440] | en |
| Orcid | Hanieh Raji [0000-0003-0495-0807] | en |
| Orcid | Farhad Soltani [0000-0003-2655-1022] | en |
| Orcid | Gholamreza Alizade Attar [0000-0003-2748-110X] | en |
| Orcid | Seyed Mohammad Alavi [0000-0003-4328-4747] | en |
| Issued Date | 2024-06-30 | en |
| Abstract | Background: Remdesivir (GS-5734) has demonstrated in vitro activity against SARS-CoV-1 and the Middle East Respiratory Syndrome. Its effectiveness against coronavirus disease 2019 (COVID-19) infection remains under debate. Objectives: This single-arm, non-randomized clinical trial aims to assess the therapeutic effect of remdesivir on COVID-19 patients. Methods: A total of 71 eligible voluntary patients (aged ≥ 18 years) who exhibited specified symptoms of COVID-19 and tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) via RT-PCR and CT scan were included in this trial. Patients received intravenous remdesivir at a dose of 200 mg on the first day, followed by 100 mg on the subsequent 4 days, administered as single daily infusions over 5 days. The length of in-hospital stay (LOS), recovery period of COVID-19 symptoms, two-month mortality post-admission, and frequency of remdesivir-related side effects were statistically evaluated. Results: The majority of patients were male (63.4% vs. 36.6% female) and had underlying diseases (60.6%). A significant trend in recovery time was observed for all symptoms (P < 0.001) based on the Friedman test. Additionally, a significant decreasing trend was noted in the rate of intensive care unit (ICU) attendance (P < 0.001). The mean ± SD LOS was 6.55 ± 3.81 days, with most patients (59.15%) recovering and being discharged in less than 7 days. Fourteen patients (19.72%) died, and no side effects were observed. Conclusions: Our findings indicate a significant reduction in recovery time for all symptoms and a decrease in ICU attendance rates among COVID-19 patients treated with remdesivir for 5 days. However, the mortality rate was not significantly improved by remdesivir. Male gender and underlying disease may be potential risk factors associated with COVID-19 infection. Incorporating a randomized control/placebo group into the single-arm trial is recommended to enhance the reliability of results. | en |
| DOI | https://doi.org/10.69107/jjp-159569 | en |
| Keyword | Remdesivir | en |
| Keyword | COVID-19 | en |
| Keyword | Symptoms | en |
| Keyword | Length of Stay | en |
| Keyword | Mortality | en |
| Publisher | Brieflands | en |
| Title | Evaluating the Therapeutic Effect of Remdesivir on COVID-19 Patients: A Single-Arm and Non-randomized Clinical Trial | en |
| Type | Research Article | en |
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