학술논문
Efficacy of Early Treatment With Favipiravir on Disease Progression Among High-Risk Patients With Coronavirus Disease 2019 (COVID-19): A Randomized, Open-Label Clinical Trial.
Document Type
Article
Author
Chuah, Chuan Huan; Chow, Ting Soo; Hor, Chee Peng; Cheng, Joo Thye; Ker, Hong Bee; Lee, Heng Gee; Lee, Kok Soon; Nordin, Noridah; Ng, Tiang Koi; Zaid, Masliza; Zaidan, Nor Zaila; Wahab, Suhaila Abdul; Adnan, Nurul Ashikin; Nordin, Noorlina; Tee, Tze Yuan; Ong, Su Miin; Chidambaram, Suresh Kumar; Mustafa, Mahiran; Group, Malaysian Favipiravir Study
Source
Subject
*DISEASE progression
*DRUG efficacy
*INTENSIVE care units
*COVID-19
*CONFIDENCE intervals
*ANTIVIRAL agents
*RISK assessment
*RANDOMIZED controlled trials
*ARTIFICIAL respiration
*HOSPITAL mortality
*PUBLIC hospitals
*DESCRIPTIVE statistics
*STATISTICAL sampling
*ODDS ratio
*EARLY medical intervention
*HYPOXEMIA
*PHARMACODYNAMICS
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Language
ISSN
1058-4838
Abstract
Background The role of favipiravir in preventing disease progression in coronavirus disease 2019 (COVID-19) remains uncertain. We aimed to determine its effect in preventing disease progression from nonhypoxia to hypoxia among high-risk COVID-19 patients. Methods This was an open-label, randomized clinical trial conducted at 14 public hospitals across Malaysia (February–July 2021) among 500 symptomatic, RT-PCR–confirmed COVID-19 patients, aged ≥50 years with ≥1 comorbidity, and hospitalized within first 7 days of illness. Patients were randomized 1:1 to favipiravir plus standard care or standard care alone. Favipiravir was administered at 1800 mg 2×/day on day 1 followed by 800 mg 2×/day until day 5. The primary endpoint was rate of clinical progression from nonhypoxia to hypoxia. Secondary outcomes included rates of mechanical ventilation, intensive care unit (ICU) admission, and in-hospital mortality. Results Of 500 patients randomized (mean [SD] age, 62.5 [8.0] years; 258 women [51.6%]; 251 [50.2%] had COVID-19 pneumonia), 487 (97.4%) patients completed the trial. Clinical progression to hypoxia occurred in 46 (18.4%) patients on favipiravir plus standard care and 37 (14.8%) on standard care alone (OR, 1.30; 95% CI:.81–2.09; P = .28). All 3 prespecified secondary endpoints were similar between both groups. Mechanical ventilation occurred in 6 (2.4%) vs 5 (2.0%) (OR, 1.20; 95% CI:.36–4.23; P = .76), ICU admission in 13 (5.2%) vs 12 (4.8%) (OR, 1.09; 95% CI:.48–2.47; P = .84), and in-hospital mortality in 5 (2.0%) vs 0 (OR, 12.54; 95% CI:.76–207.84; P = .08) patients. Conclusions Among COVID-19 patients at high risk of disease progression, early treatment with oral favipiravir did not prevent their disease progression from nonhypoxia to hypoxia. Clinical Trials Registration ClinicalTrials.gov (NCT04818320). [ABSTRACT FROM AUTHOR]