Early Treatment of Favipiravir in COVID-19 Patients Without Pneumonia: A Multicentre, Open-Labelled, Randomized Control Study
RCT 93 patients in Thailand showing significantly faster clinical improvement with favipiravir treatment. 1800mg favipiravir bid day 1, 800mg bid 5-14 days until PCR-.
time to clinical improvement, 63.9% lower, HR 0.36, p < 0.001, treatment 62, control 31, inverted to make HR<1 favor treatment, primary outcome.
|
clinical improvement, 89.9% lower, OR 0.10, p < 0.001, treatment 62, control 31, inverted to make OR<1 favor treatment, logistic regression, day 14, RR approximated with OR.
|
risk of mild pneumonia, 42.9% lower, RR 0.57, p = 0.25, treatment 8 of 62 (12.9%), control 7 of 31 (22.6%), NNT 10.
|
risk of no viral clearance, 4.2% higher, HR 1.04, p = 0.87, treatment 62, control 31, adjusted per study, inverted to make HR<1 favor treatment.
|
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
|
Sirijatuphat et al., 8 Jun 2022, Randomized Controlled Trial, Thailand, peer-reviewed, 9 authors, trial
TCTR20200514001.
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2022.06.06.22275902; this version posted June 8, 2022. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC-ND 4.0 International license .
1
Early Treatment of Favipiravir in COVID-19 Patients Without Pneumonia: A Multicentre,
2
Open-Labelled, Randomized Control Study
3
Rujipas Sirijatuphata, Weerawat Manosuthib, Suvimol Niyomnaithamc,d, Andrew Owene,
4
Katherine K. Copelandf, Lantharita Charoenpongb, Manoch Rattanasompattikulg, Surakameth
5
Mahasirimongkolh, Kulkanya Chokephaibulkitd,i*
6
7
a
8
Thailand; bBamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi,
9
Thailand; cDepartment of Pharmacology, Faculty of Medicine Siriraj Hospital, Mahidol
10
University, Thailand; dSiriraj Institute of Clinical Research (SICRES), Mahidol University,
11
Thailand; eInstitute of Systems, Molecular and Integrative Biology, University of Liverpool,
12
United Kingdom; fMahidol University International College, Salaya, Nakhon Pathom, Thailand;
13
g
14
Mahidol University, Thailand; hDivision of Genomic Medicine and Innovation Support,
15
Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand; iDepartment
16
of Paediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University,
Medical Department, Golden Jubilee Medical Centre, Faculty of Medicine Siriraj Hospital,
17
18
*Corresponding author: Kulkanya Chokephaibulkit, MD,
19
2 Wanglang Road, Bangkoknoi, Bangkok 10700, Thailand
20
Tel: (+66) 2-4141899; Fax: (+66) 2-4128243,
21
E-mail: kulkanya.cho@mahidol.ac.th.
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
medRxiv preprint doi: https://doi.org/10.1101/2022.06.06.22275902; this version posted June 8, 2022. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC-ND 4.0 International license .
22
Abstract
23
We investigated Favipiravir (FPV) efficacy in mild cases of COVID-19 without pneumonia and
24
its effects towards viral clearance, clinical condition, and risk of COVID-19 pneumonia
25
development. PCR-confirmed SARS-CoV-2-infected patients without pneumonia were enrolled
26
(2:1) within 10 days of symptomatic onset into FPV and control arms. The former received 1800
27
mg FPV twice-daily (BID) on Day 1 and 800 mg BID 5-14 days thereafter until negative viral
28
detection, while the latter received supportive care only. The primary endpoint was time to clinical
29
improvement, which was defined by a reduced National Early Warning Score (NEWS) or score of
30
<1. 62 patients (41 female) comprised the FPV arm (median age: 32 years, median BMI: 22 kg/m²)
31
and 31 patients (19 female) comprised the control arm (median age: 28 years, median BMI: 22
32
kg/m². The median time to sustained clinical improvement by NEWS was 2 vs 14 days for FPV
33
and control arms respectively (adjusted hazard ratio (aHR) of 2.77, 95% CI 1.57-4.88, P <0.001).
34
The FPV arm also had significantly higher likelihoods of..
Please send us corrections, updates, or comments. Vaccines and
treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, or intervention
is 100% available and effective for all current and future variants. We do not
provide medical advice. Before taking any medication, consult a qualified
physician who can provide personalized advice and details of risks and
benefits based on your medical history and situation.
FLCCC and
WCH
provide treatment protocols.
Submit