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      Effect of umifenovir (arbidol) versus standard care on clinical outcome in patients with COVID-19: a retrospective cohort study

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          Abstract

          Background:

          Coronavirus disease 2019 (COVID-19) continues to spread quickly throughout the world, mainly due to the lack of effective drug therapies and vaccines. The effectiveness of the antiviral drug umifenovir needs to be further clarified.

          Methods:

          This retrospective cohort study included 1254 patients who were diagnosed with COVID-19 between February 19 and April 5, 2020 in Hubei Maternity and Child Health Hospital. They were divided into umifenovir group ( n = 760, 60.60%) and control group ( n = 496) without using umifenovir. The primary endpoint was a composite of intubation or death in a time-to-event analysis. The clinical outcomes were compared between the two groups using multivariable Cox analysis with inverse probability weighting according to the propensity score.

          Results:

          A total of 760 (60.60%) patients received umifenovir, and 496 patients did not do so. Of the enrolled patients, 1049 (83.65%) had mild or moderate COVID-19, and the remaining 205 had severe or critical COVID-19. The mortality rate in the umifenovir group was 2.76% (21/760) versus 2.02% (10/494) in the control group. In terms of treatment outcomes, the discharge status of the patients in the umifenovir group was no better than that in the control group after propensity score matching ( n = 485 in each group). In addition, the respiratory rate, a severe condition, or critical condition of the disease were the three main risk factors affecting the endpoint of death ( p = 0.0028, p = 0.0009 and p < 0.0001, respectively).

          Conclusion:

          This retrospective cohort study showed that oral administration of umifenovir alone did not improve outcomes for patients with COVID-19.

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          Most cited references19

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          A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19

          Abstract Background No therapeutics have yet been proven effective for the treatment of severe illness caused by SARS-CoV-2. Methods We conducted a randomized, controlled, open-label trial involving hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2) to the fraction of inspired oxygen (Fio 2) of less than 300 mm Hg. Patients were randomly assigned in a 1:1 ratio to receive either lopinavir–ritonavir (400 mg and 100 mg, respectively) twice a day for 14 days, in addition to standard care, or standard care alone. The primary end point was the time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first. Results A total of 199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the lopinavir–ritonavir group, and 100 to the standard-care group. Treatment with lopinavir–ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72). Mortality at 28 days was similar in the lopinavir–ritonavir group and the standard-care group (19.2% vs. 25.0%; difference, −5.8 percentage points; 95% CI, −17.3 to 5.7). The percentages of patients with detectable viral RNA at various time points were similar. In a modified intention-to-treat analysis, lopinavir–ritonavir led to a median time to clinical improvement that was shorter by 1 day than that observed with standard care (hazard ratio, 1.39; 95% CI, 1.00 to 1.91). Gastrointestinal adverse events were more common in the lopinavir–ritonavir group, but serious adverse events were more common in the standard-care group. Lopinavir–ritonavir treatment was stopped early in 13 patients (13.8%) because of adverse events. Conclusions In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir–ritonavir treatment beyond standard care. Future trials in patients with severe illness may help to confirm or exclude the possibility of a treatment benefit. (Funded by Major Projects of National Science and Technology on New Drug Creation and Development and others; Chinese Clinical Trial Register number, ChiCTR2000029308.)
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            Pathophysiology, Transmission, Diagnosis, and Treatment of Coronavirus Disease 2019 (COVID-19): A Review

            The coronavirus disease 2019 (COVID-19) pandemic, due to the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has caused a worldwide sudden and substantial increase in hospitalizations for pneumonia with multiorgan disease. This review discusses current evidence regarding the pathophysiology, transmission, diagnosis, and management of COVID-19.
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              Presumed Asymptomatic Carrier Transmission of COVID-19

              This study describes possible transmission of novel coronavirus disease 2019 (COVID-19) from an asymptomatic Wuhan resident to 5 family members in Anyang, a Chinese city in the neighboring province of Hubei.
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                Author and article information

                Contributors
                Role: Writing – original draft
                Role: Writing – original draft
                Role: Resources
                Role: Data curationRole: Funding acquisition
                Role: Data curationRole: Writing – review & editing
                Role: Data curationRole: Writing – review & editing
                Journal
                Ther Adv Respir Dis
                Ther Adv Respir Dis
                TAR
                sptar
                Therapeutic Advances in Respiratory Disease
                SAGE Publications (Sage UK: London, England )
                1753-4658
                1753-4666
                3 July 2023
                Jan-Dec 2023
                3 July 2023
                : 17
                : 17534666231183811
                Affiliations
                [1-17534666231183811]Department of Nuclear Medicine, Shanghai Tenth People’s Hospital, Tongji University School of Medicine, Shanghai, China
                [2-17534666231183811]Shanghai Research Center for Thyroid Diseases, Shanghai Tenth People’s Hospital, Tongji University School of Medicine, Shanghai, China
                [3-17534666231183811]Department of Integrated Chinese and Western Medicine, Eastern Hepatobiliary Surgery Hospital, Navy Medical University (Second Military Medical University), Shanghai, China
                [4-17534666231183811]Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Navy Medical University (Second Military Medical University), Changhai Road 225, Yangpu District, Shanghai 200438, China
                [5-17534666231183811]Department of Infectious Medicine, Maternal and Child Health Hospital of Hubei Province, Wuhan, China
                [6-17534666231183811]Department of Respiratory and Critical Care Medicine, Shanghai Tenth People’s Hospital, Tongji University School of Medicine, Yan Chang Middle Road 301, Shanghai 20072, China
                [7-17534666231183811]Department of Nuclear Medicine, Shanghai Tenth People’s Hospital, Tongji University School of Medicine, Yanchang Middle Road 301, Shanghai 20072, China
                Author notes
                [*]

                These authors contributed equally to the article.

                Author information
                https://orcid.org/0000-0001-8263-6616
                Article
                10.1177_17534666231183811
                10.1177/17534666231183811
                10328169
                37395539
                f50f63e2-30f6-4067-bc1c-900837e0ab51
                © The Author(s), 2023

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 11 July 2022
                : 7 June 2023
                Categories
                Original Research
                Custom metadata
                January-December 2023
                ts1

                covid-19,interquartile range,lymphocyte,treatment,umifenovir

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