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.
| Autor: | 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 |
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| Předmět: |
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 |
| Zdroj: | Clinical Infectious Diseases; Jul2022, Vol. 75 Issue 1, pe432-e439, 8p |
| Abstrakt: | 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] |
| Databáze: | Complementary Index |
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