Early Treatment of High-Risk Hospitalized Coronavirus Disease 2019 (COVID-19) Patients With a Combination of Interferon Beta-1b and Remdesivir: A Phase 2 Open-label Randomized Controlled Trial

医学 临床终点 养生 内科学 危险系数 置信区间 随机对照试验 不利影响 病毒载量 胃肠病学 免疫学 病毒
作者
Anthony Raymond Tam,Ricky Ruiqi Zhang,Kwok Cheung Lung,Raymond W. Liu,Ka Nang Leung,Danlei Liu,Yu-Jing Fan,Lu Lu,Athene Hoi Ying Lam,Tom Wai-Hin Chung,Cyril C. Y. Yip,Jenny Lo,Alan H.B. Wu,Rodney A. Lee,Simon Sin,Pauline C. Ng,Wai Kin Chan,Hoi-Ping Shum,Wing-Wa Yan,Jasper Fuk-Woo Chan,Vincent C.C. Cheng,Chak Sing Lau,Kelvin Kai-Wang,Kwok-Hung Chan,Kwok-Yung Yuen,Ivan Hung
出处
期刊:Clinical Infectious Diseases [Oxford University Press]
被引量:5
标识
DOI:10.1093/cid/ciac523
摘要

Abstract Background Early antiviral therapy was effective in the treatment of coronavirus disease 2019 (COVID-19). We assessed the efficacy and safety of combined interferon beta-1b and remdesivir treatment in hospitalized COVID-19 patients. Methods We conducted a multicentre, prospective open-label, randomized-controlled trial involving high-risk adults hospitalized for COVID-19. Patients were randomly assigned to a 5-day interferon beta-1b 16 million units daily and remdesivir 200 mg loading on day 1 followed by 100 mg daily on day 2 to 5 (combination group), or to remdesivir only of similar regimen (control group) (1:1). The primary endpoint was the time to complete alleviation of symptoms (NEWS2 = 0). Results Two-hundred and twelve patients were enrolled. The median days of starting treatment from symptom onset was 3 days. The median age was 65 years, and 159 patients (75%) had chronic disease. The baseline demographics were similar. There was no mortality. For the primary endpoint, the combination group was significantly quicker to NEWS2 = 0 (4 vs 6.5 days; hazard ratio [HR], 6.59; 95% confidence interval [CI], 6.1–7.09; P < .0001) when compared to the control group. For the secondary endpoints, the combination group was quicker to negative nasopharyngeal swab (NPS) viral load (VL) (6 vs 8 days; HR, 8.16; 95% CI, 7.79–8.52; P < .0001) and to develop seropositive immunoglobulin G (IgG) (8 vs 10 days; HR, 10.78; 95% CI, 9.98–11.58; P < .0001). All adverse events resolved upon follow-up. Combination group (HR, 4.1 95% CI, 1.9–8.6, P < .0001) was the most significant independent factor associated with NEWS2 = 0 on day 4. Conclusions Early treatment with interferon beta-1b and remdesivir was safe and better than remdesivir only in alleviating symptoms, and in shortening viral shedding and hospitalization with earlier seropositivity in high-risk COVID-19 patients.
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