Kamal Lina, Ramadan Ahmed, Farraj Suha, Bahig Lydia, Ezzat Sameera
Mounir Armanious Research Center (MARC), Egypt.
Department of Applied Statistics, Faculty of Postgraduate Studies for Statistical Research, Cairo University, Egypt.
Saudi Pharm J. 2022 May;30(5):508-518. doi: 10.1016/j.jsps.2022.03.002. Epub 2022 Mar 10.
Throughout the time of the global pandemic of SARS-CoV-2 virus, there has been a compelling necessity for the development of effective antiviral agents and prophylactic vaccines to limit the virus spread, disease burden, hospitalization, and mortality. Until mid of 2021, the NIH treatment guideline declared no single oral therapy was proven to treat mild to moderate cases. A new hope arose when a repurposed direct acting oral anti-viral agent "Molnupiravir" was shown to be effective in decreasing mortality and need for hospitalization in mild to moderate cases with relatively good safety profile; exhibiting a significant reduction in virus titers only after two days from administration. Molnupiravir recently granted the FDA emergency use authorization to treat mild to moderate COVID-19 patients with at least one risk factor for progression.
We performed a computer-based literature search of (PubMed, Science direct, MedRxiv, BioRxiv, ClinicalTrials.gov, ISRCTN, Cochrane COVID study register, EU registry, and CTRI registry) till February 15th, 2022. The following keywords were used in our search ("Molnupiravir", "NHC", "EIDD-2807", "MK-4482" or "EIDD-1931").
We identified from the initial search a total of 279 articles; 246 articles (BioRxiv and MedRxiv N = 186, PubMed N = 33, Science direct N = 27) and 33 Clinical trials from the following registries (ISCTRN (N = 1), Clinical Trials.gov (N = 6), CTRI (N = 12), Cochrane (N = 14)). Through screening phases, 21 records were removed as duplicates and 198 irrelevant records were also excluded. The included studies in this systematic review were (N = 60) included 39 published papers and 21 clinical trials. After Manual addition (N = 4), the qualitative assessment included (N = 64).
Based on the cumulative evidence from preclinical and clinical studies, Molnupiravir is proven to be a well tolerated, direct acting oral anti-viral agent to halt the disease progression in mild to moderate COVID-19 cases; in terms of mortality and hospitalization rates.
在严重急性呼吸综合征冠状病毒2（SARS-CoV-2）全球大流行期间，迫切需要研发有效的抗病毒药物和预防性疫苗，以限制病毒传播、疾病负担、住院率和死亡率。直到2021年年中，美国国立卫生研究院（NIH）的治疗指南宣称，尚无单一口服疗法被证明可治疗轻至中度病例。当一种重新利用的直接作用口服抗病毒药物“莫努匹韦”被证明在轻至中度病例中能有效降低死亡率和住院需求，且安全性相对良好时，新的希望出现了；给药仅两天后病毒滴度就显著降低。莫努匹韦最近获得了美国食品药品监督管理局（FDA）的紧急使用授权，用于治疗至少有一个病情进展风险因素的轻至中度新冠肺炎患者。
我们在2022年2月15日前对（PubMed、Science direct、MedRxiv、BioRxiv、ClinicalTrials.gov、ISRCTN、Cochrane COVID研究注册库、欧盟注册库和CTRI注册库）进行了基于计算机的文献检索。我们在检索中使用了以下关键词（“莫努匹韦”、“NHC”、“EIDD-2807”、“MK-4482”或“EIDD-1931”）。
我们从初始检索中识别出总共279篇文章；246篇文章（BioRxiv和MedRxiv共186篇，PubMed 33篇，Science direct 27篇）以及来自以下注册库的33项临床试验（国际标准随机对照试验编号注册库（ISCTRN，1篇）、ClinicalTrials.gov（6篇）、印度临床试验注册库（CTRI，12篇）、Cochrane（14篇））。在筛选阶段，21条记录作为重复记录被移除，198条不相关记录也被排除。本系统评价纳入的研究（共60项）包括39篇已发表论文和21项临床试验。人工补充（4项）后，定性评估纳入（共64项）。
基于临床前和临床研究的累积证据，莫努匹韦被证明是一种耐受性良好的直接作用口服抗病毒药物，可在轻至中度新冠肺炎病例中阻止疾病进展；在死亡率和住院率方面。
