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Randomized Controlled Trial
. 2022 Aug 24;75(1):e432-e439.
doi: 10.1093/cid/ciab962.

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

Chuan Huan Chuah  1 , Ting Soo Chow  1 , Chee Peng Hor  2   3 , Joo Thye Cheng  4 , Hong Bee Ker  5 , Heng Gee Lee  6 , Kok Soon Lee  7 , Noridah Nordin  8 , Tiang Koi Ng  9 , Masliza Zaid  10 , Nor Zaila Zaidan  11 , Suhaila Abdul Wahab  12 , Nurul Ashikin Adnan  13 , Noorlina Nordin  14 , Tze Yuan Tee  15 , Su Miin Ong  16 , Suresh Kumar Chidambaram  17 , Mahiran Mustafa  8 ; Malaysian Favipiravir Study Group
Collaborators, Affiliations
Randomized Controlled Trial

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

Chuan Huan Chuah et al. Clin Infect Dis. .

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).

Keywords: COVID-19; disease progression; favipiravir; high-risk group; mortality.

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