Portal de Periódicos da CAPES

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

2021; Oxford University Press; Volume: 75; Issue: 1 Linguagem: Inglês

10.1093/cid/ciab962

1537-6591

Chuan Huan Chuah, Ting Soo Chow, Chee Peng Hor, Joo Thye Cheng, Hong Bee Ker, Heng Gee Lee, Kok Soon Lee, Noridah Nordin, Tiang Koi Ng, Masliza Zaid, Nor Zaila Binti Zaidan, Suhaila Abdul Wahab, Nurul Ashikin Adnan, Noorlina Nordin, Tze Yuan Tee, Su Miin Ong, Suresh Kumar Chidambaram, Mahiran Mustafa, Kok Soon Lee, Chung Yeow Wong, Jian Hao Sim, Nicholas Hee Ken Yoong, Pei Sun Tan, Kalaiarasu M. Peariasamy, Su Miin Ong, Chin Tho Leong, Chun Keat Chew, Mohan Dass Pathmanathan, Muhammad Luqman Hamzah, Joo Thye Cheng, Chee Peng Hor, Ammar Rashidi Abdullah, Yee Jie Teoh, Yi Fang Lim, Nor Zaila Binti Zaidan, Delarina Frimawati Othman Andu, Divya Rajendra R Ajmera, Karamjit Kaur Sarban Singh, Nurnadiah Kamarudin, Peter Andrew Natarajan, Qin Le Tay, Seri Rabiatul Nur Abu Salim, Shalini Vijayasingham, Yik Zhi Kum, Ting Soo Chow, Peng Shyan Wong, Kar Nim Leong, Chuan Huan Chuah, Bai Han Ooi, Farah Nadiah Bidin, Kong Yeow Kang, Mann Leon Chin, Shiao Xian Lim, Shin Wuei Tan, Wen Yao Mak, Yeung Hsen Chan, Heng Gee Lee, Y A Tan, Yen Tsen Saw, Yiko Wong, Hong Bee Ker, Balasurindiran Muniandy, Han Lin Guan, Chee Loon Lim, Pamela Saw Varn Teing, Mahiran Mustafa, Noridah Nordin, Muhammad Aizat Amiruddin, Raja Ahmad Reza Raja Lope Ahmad, Suhaili Mohammad, Masliza Zaid, Ji Ken Ow, Jian Hao Sim, Karin Lam, Kok Soon Lee, Nurul Ashikin Adnan, Ahmad Kashfi Ab Rahman, Mohd Haidi Syuhairi Hanafi, Nurul Izza Md Yusof, Wirdatul Ainna Jamaluddin, Suresh Kumar Chidambaram, Amira Naziffa Shamsuddin, Hiu Jian Chua, Isaac Heen George, Kim Heng Tay, Kok Tong Tan, Lavanya Narayanan, Kah Chuan Lim, Nisshata Subramaniam, Nur Suriana Mah Hassan, Pearly Sim Kim Aik, Raja Nurulain Raja Nahar Putra, Sharmila Mohd Nadzir, Syarifah Nurul Ain, Tharmini a p Ravi, Yan Chyi Tan, Tze Yuan Tee, Foo Weng Lee, Giri Shan Rajahram, Marsilla Marzukie, Shivanessh Kerisnasamy, Tzeng Lin Wong, Noorlina Nordin, K Chen, Masyitah Haji Mohamad, Muhammad Hazrul Badrul Hisham, Nik Fathanah Nik Ali, Wai Tong Lim, Suhaila Abdul Wahab, Amalina Anuar, Chee Kong Wong, Karniza Khalid, Wei Chern Ang, Tiang Koi Ng, Chia Min Chong, Hui Ying Chan, Thangavelu Suvintheran,

Long-Term Effects of COVID-19

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).