Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial
et al., Infect. Dis. Ther., doi:10.1007/s40121-021-00496-6
, Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID19 (FACCT.., Infect. Dis. Ther., doi:10.1007/s40121-021-00496-6
RCT 254 very late stage (93% on oxygen, 17% in ICU at baseline) hospitalized patients in Saudi Arabia not showing significant differences with HCQ+favipiravir treatment. Only SaO2 < 94% patients were eligible, however the actual SaO2 of enrolled patients is not provided.
This study is excluded in the after exclusion results of meta
analysis:
very late stage, >50% on oxygen/ventilation at baseline.
|
risk of death, 3.7% lower, RR 0.96, p = 0.91, treatment 14 of 125 (11.2%), control 15 of 129 (11.6%), NNT 234, 90 days.
|
|
risk of death, 28.6% lower, RR 0.71, p = 0.45, treatment 9 of 125 (7.2%), control 13 of 129 (10.1%), NNT 35, 28 days.
|
|
risk of death, 65.1% higher, RR 1.65, p = 0.68, treatment 8 of 125 (6.4%), control 5 of 129 (3.9%), 14 days.
|
|
risk of mechanical ventilation, 8.4% higher, RR 1.08, p = 0.78, treatment 21 of 125 (16.8%), control 20 of 129 (15.5%).
|
|
risk of ICU admission, 31.0% higher, RR 1.31, p = 0.24, treatment 33 of 125 (26.4%), control 26 of 129 (20.2%).
|
|
recovery time, 28.6% higher, relative time 1.29, p = 0.29, treatment 125, control 129.
|
|
hospitalization time, 12.5% higher, relative time 1.12, p = 0.42, treatment 125, control 129.
|
|
risk of no viral clearance, 2.6% lower, RR 0.97, p = 0.75, treatment 100 of 125 (80.0%), control 106 of 129 (82.2%), NNT 46.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Bosaeed et al., 30 Apr 2021, Randomized Controlled Trial, Saudi Arabia, peer-reviewed, 30 authors, average treatment delay 5.85 days.
Abstract: Infect Dis Ther (2021) 10:2291–2307
https://doi.org/10.1007/s40121-021-00496-6
ORIGINAL RESEARCH
Favipiravir and Hydroxychloroquine Combination
Therapy in Patients with Moderate to Severe COVID19 (FACCT Trial): An Open-Label, Multicenter,
Randomized, Controlled Trial
Mohammad Bosaeed
. Ebrahim Mahmoud . Ahmad Alharbi . Hadeel Altayib . Hawra Albayat . Faisal Alharbi .
Khalid Ghalilah . Abdulmajid Al Arfaj . Jumana AlJishi . Abdullatif Alarfaj . Hajar Alqahtani . Badriah M. Almutairi . Manar Almaghaslah . Nawaf M. Alyahya . Abdullah Bawazir . Saud AlEisa . Abdulrahman Alsaedy .
Abderrezak Bouchama . Malak Alharbi . Majid AlShamrani . Sameera Al Johani . Majed Aljeraisy .
Mohammed Alzahrani . Abdulhakeem O. Althaqafi . Hassan Almarhabi . Athari Alotaibi . Nasser Alqahtani .
Yaseen M. Arabi . Omar S. Aldibasi . Ahmad Alaskar
Received: June 3, 2021 / Accepted: July 1, 2021 / Published online: July 28, 2021
Ó The Author(s) 2021
ABSTRACT
Introduction: Antiviral drugs have shown limited effectiveness in treating patients with
Supplementary Information The online version
contains supplementary material available at https://
doi.org/10.1007/s40121-021-00496-6.
M. Bosaeed (&) E. Mahmoud A. Alharbi
M. Almaghaslah N. M. Alyahya A. Bawazir
S. AlEisa A. Alsaedy
Department of Medicine, King Abdulaziz Medical
City, Ministry of National Guard Health Affairs,
Riyadh, Saudi Arabia
e-mail: bosaeedmo@ngha.med.sa
M. Bosaeed E. Mahmoud A. Alharbi A. Alsaedy
M. AlShamrani Y. M. Arabi A. Alaskar
College of Medicine, King Saud Bin Abdulaziz
University for Health Sciences, Riyadh, Saudi Arabia
M. Bosaeed B. M. Almutairi A. Bouchama
M. AlShamrani S. Al Johani M. Aljeraisy
Y. M. Arabi O. S. Aldibasi A. Alaskar
King Abdullah International Medical Research
Center, Riyadh, Saudi Arabia
H. Altayib M. Alzahrani A. O. Althaqafi
H. Almarhabi
Department of Medicine, King Abdulaziz Medical
City, Jeddah, Saudi Arabia
coronavirus disease 2019 (COVID-19). We
aimed to assess the effects of a favipiravir and
hydroxychloroquine combination on treating
moderate-to-severe COVID-19 patients.
Methods: An investigator-initiated, multicenter, open-label, randomized trial at nine hospitals. Eligible patients were adults with
moderate-to-severe COVID-19 defined as
H. Albayat
Imam Abdulrahman Alfaisal Hospital, Riyadh, Saudi
Arabia
F. Alharbi
Department of Infectious Diseases, King Abdul Aziz
Hospital, Makkah, Saudi Arabia
K. Ghalilah M. Alharbi
Department of Infectious Diseases, King Salman
Medical City, Madinah, Saudi Arabia
A. Al Arfaj
King Abdulaziz Hospital- Ministry of National Guard
Health Affairs, Al Ahsa, Saudi Arabia
J. AlJishi
Internal Medicine Department, Qatif Central
Hospital, Al Qatif, Eastern Province, Saudi Arabia
A. Alarfaj
Imam Abdulrahman Al Faisal Hospital- Ministry of
National Guard Health Affairs, Dammam, Saudi
Arabia
2292
Infect Dis Ther (2021) 10:2291–2307
oxygen saturation (SaO2) of B 94% while
breathing ambient air or significant clinical
symptoms with chest x-ray changes requiring
hospital admission. Randomization was in a 1:1
ratio to receive standard care (control group) or
standard care plus favipiravir and hydroxychloroquine. The primary outcome was time to
clinical improvement of two points (from the
status at randomization) on a seven-category
ordinal scale or live discharge from the hospital
within 14 days. Analyses were done in an
intention-to-treat population.
Results: From May 2020 to Jan..
Late treatment
is less effective
is less effective
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.