Efficacy of Early Treatment with Favipiravir on Disease Progression among High Risk COVID-19 Patients: A Randomized, Open-Label Clinical Trial.
BACKGROUND
Role of favipiravir in preventing disease progression in COVID-19 remains uncertain. We aimed to determine its effect in preventing disease progression from non-hypoxia to hypoxia among high risk COVID-19 patients.


STUDY DESIGN
This was an open-label, randomized clinical trial conducted at 14 public hospitals across Malaysia from February to June 2021 among 500 symptomatic, RT-PCR confirmed COVID-19 patients, aged ≥50 years with ≥1 co-morbidity, and hospitalized within first 7 days of illness. Patients were randomized on 1:1 ratio to favipiravir plus standard care or standard care alone. Favipiravir was administered at 1800mg twice-daily on day 1 followed by 800mg twice-daily until day 5. The primary endpoint was rate of clinical progression from non-hypoxia to hypoxia. Secondary outcomes included rates of mechanical ventilation, intensive care unit (ICU) admission, and in-hospital mortality.


RESULTS
Among 500 patients were randomized (mean age, 62.5 [SD 8.0] years; 258 women [51.6%]; and 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, 0.81-2.09; P=.28). All three pre-specified secondary end points were similar between both groups. Mechanical ventilation occurred in 6 (2.4%) vs 5 (2.0%) (OR 1.20; 95%CI, 0.36-4.23; P=.76), ICU admission in 13 (5.2%) vs 12 (4.8%) (OR 1.09; 95%CI, 0.48-2.47; P=.84), and in-hospital mortality in 5 (2.0%) vs 0 (OR 12.54; 95%CI, 0.76- 207.84; P=.08).


CONCLUSIONS
Among COVID-19 patients at high risk of disease progression, early treatment with oral favipiravir did not prevent their disease progression from non-hypoxia to hypoxia.
['Chuah|Chuan Huan|CH|0000-0003-4172-8949', 'Chow|Ting Soo|TS|', 'Hor|Chee Peng|CP|0000-0003-0119-6634', 'Cheng|Joo Thye|JT|', 'Ker|Hong Bee|HB|', 'Lee|Heng Gee|HG|', 'Lee|Kok Soon|KS|', 'Nordin|Noridah|N|', 'Ng|Tiang Koi|TK|', 'Zaid|Masliza|M|', 'Zaidan|Nor Zaila|NZ|', 'Abdul Wahab|Suhaila|S|', 'Adnan|Nurul Ashikin|NA|', 'Nordin|Noorlina|N|', 'Tee|Tze Yuan|TY|', 'Ong|Su Miin|SM|', 'Chidambaram|Suresh Kumar|SK|', 'Mustafa|Mahiran|M|']
favipiravir disease progression COVID-19 mortality high-risk group