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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.
Tam, Anthony Raymond; Zhang, Ricky Ruiqi; Lung, Kwok-Cheung; Liu, Raymond; Leung, Ka-Yi; Liu, Danlei; Fan, Yujing; Lu, Lu; Lam, Athene Hoi-Ying; Chung, Tom Wai-Hin; Yip, Cyril Chik-Yan; Lo, Jenny; Wu, Alan Ka-Lun; Lee, Rodney; Sin, Simon; Ng, Pauline Yeung; Chan, Wai-Ming; Shum, Hoi-Ping; Yan, Wing-Wa; Chan, Jasper Fuk-Woo; Cheng, Vincent Chi-Chung; Lau, Chak-Sing; To, Kelvin Kai-Wang; Chan, Kwok-Hung; Yuen, Kwok-Yung; Hung, Ivan Fan-Ngai.
Afiliação
  • Tam AR; Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
  • Zhang RR; Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
  • Lung KC; State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, Department of Microbiology, The University of Hong Kong, Hong Kong SAR, China.
  • Liu R; Department of Medicine, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.
  • Leung KY; Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong SAR, China.
  • Liu D; State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, Department of Microbiology, The University of Hong Kong, Hong Kong SAR, China.
  • Fan Y; Department of Microbiology, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
  • Lu L; Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
  • Lam AH; State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, Department of Microbiology, The University of Hong Kong, Hong Kong SAR, China.
  • Chung TW; Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
  • Yip CC; State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, Department of Microbiology, The University of Hong Kong, Hong Kong SAR, China.
  • Lo J; State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, Department of Microbiology, The University of Hong Kong, Hong Kong SAR, China.
  • Wu AK; Department of Microbiology, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
  • Lee R; Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
  • Sin S; State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, Department of Microbiology, The University of Hong Kong, Hong Kong SAR, China.
  • Ng PY; Department of Microbiology, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
  • Chan WM; Department of Microbiology, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
  • Shum HP; Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong SAR, China.
  • Yan WW; Department of Clinical Pathology, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.
  • Chan JF; Department of Clinical Pathology, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.
  • Cheng VC; Department of Intensive Care, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
  • Lau CS; Department of Intensive Care, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
  • To KK; Department of Intensive Care, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
  • Chan KH; Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.
  • Yuen KY; Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.
  • Hung IF; State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, Department of Microbiology, The University of Hong Kong, Hong Kong SAR, China.
Clin Infect Dis ; 76(3): e216-e226, 2023 02 08.
Article em En | MEDLINE | ID: mdl-35762834
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. CLINICAL TRIALS REGISTRATION: NCT04647695.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Antivirais / Interferon beta-1b / COVID-19 / Tratamento Farmacológico da COVID-19 Tipo de estudo: Clinical_trials / Etiology_studies / Risk_factors_studies Limite: Aged / Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Antivirais / Interferon beta-1b / COVID-19 / Tratamento Farmacológico da COVID-19 Tipo de estudo: Clinical_trials / Etiology_studies / Risk_factors_studies Limite: Aged / Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article