Phase II Clinical Trial of Combination Therapy with Favipiravir and Methylprednisolone for COVID-19 with Non-Critical Respiratory Failure View Full Text


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Article Info

DATE

2021-08-08

AUTHORS

Yuichiro Shindo, Yasuhiro Kondoh, Akiko Kada, Yohei Doi, Keisuke Tomii, Hiroshi Mukae, Naohiko Murata, Ryosuke Imai, Masaki Okamoto, Yasuhiko Yamano, Yasunari Miyazaki, Masahiro Shinoda, Hiromichi Aso, Shinyu Izumi, Haruyuki Ishii, Ryota Ito, Akiko M. Saito, Toshiki I. Saito, Yoshinori Hasegawa

ABSTRACT

IntroductionThe administration of systemic corticosteroids is a key strategy for improving COVID-19 outcomes. However, evidence is lacking on combination therapies of antiviral agents and systemic corticosteroids. The objective of this study was to investigate the efficacy and safety of the combination therapy of favipiravir and methylprednisolone in preventing respiratory failure progression in patients with COVID-19 and non-critical respiratory failure.MethodsWe conducted a multicenter, open-label, single-arm phase II study. The patients received favipiravir 3600 mg on the first day, followed by 1600 mg for a total of 10–14 days. Methylprednisolone was administered intravenously at 1 mg/ideal body weight (IBW)/day from days 1 to 5, followed by 0.5 mg/IBW/day from days 6 to 10 if clinically indicated. The primary endpoint was the proportion of patients requiring mechanical ventilation (MV) (including noninvasive positive pressure ventilation) or those who met the criteria for tracheal intubation within 14 days of the study treatment initiation (MVCTI-14).ResultsSixty-nine patients were enrolled and underwent the study treatment. Of them, the MVCTI-14 proportion was 29.2% (90% confidence interval 20.1–39.9, p = 0.200). The proportion of patients who required MV or who died within 30 days was 26.2%, and 30-day mortality was 4.9%. The most significant risk factor for MVCTI-14 was a smoking history (odds ratio 4.1, 95% confidence interval 1.2–14.2). The most common grade 3–4 treatment-related adverse event was hyperglycemia, which was observed in 21.7%.ConclusionThe MVCTI-14 proportion did not reach a favorable level in the clinical trial setting with the threshold of 35%. However, the proportion of MV or death within 30 days was 26.6%, which might be close to the findings (28.1%) of the RECOVERY trial, which showed the efficacy of dexamethasone for patients with COVID-19 and non-critical respiratory failure. Further evaluation of this combination therapy is needed.Clinical Trial RegistrationJapan Registry of Clinical Trials (jRCT) identifier jRCTs041200025. More... »

PAGES

2353-2369

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s40121-021-00512-9

DOI

http://dx.doi.org/10.1007/s40121-021-00512-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1140286656

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/34368914


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9 schema:description IntroductionThe administration of systemic corticosteroids is a key strategy for improving COVID-19 outcomes. However, evidence is lacking on combination therapies of antiviral agents and systemic corticosteroids. The objective of this study was to investigate the efficacy and safety of the combination therapy of favipiravir and methylprednisolone in preventing respiratory failure progression in patients with COVID-19 and non-critical respiratory failure.MethodsWe conducted a multicenter, open-label, single-arm phase II study. The patients received favipiravir 3600 mg on the first day, followed by 1600 mg for a total of 10–14 days. Methylprednisolone was administered intravenously at 1 mg/ideal body weight (IBW)/day from days 1 to 5, followed by 0.5 mg/IBW/day from days 6 to 10 if clinically indicated. The primary endpoint was the proportion of patients requiring mechanical ventilation (MV) (including noninvasive positive pressure ventilation) or those who met the criteria for tracheal intubation within 14 days of the study treatment initiation (MVCTI-14).ResultsSixty-nine patients were enrolled and underwent the study treatment. Of them, the MVCTI-14 proportion was 29.2% (90% confidence interval 20.1–39.9, p = 0.200). The proportion of patients who required MV or who died within 30 days was 26.2%, and 30-day mortality was 4.9%. The most significant risk factor for MVCTI-14 was a smoking history (odds ratio 4.1, 95% confidence interval 1.2–14.2). The most common grade 3–4 treatment-related adverse event was hyperglycemia, which was observed in 21.7%.ConclusionThe MVCTI-14 proportion did not reach a favorable level in the clinical trial setting with the threshold of 35%. However, the proportion of MV or death within 30 days was 26.6%, which might be close to the findings (28.1%) of the RECOVERY trial, which showed the efficacy of dexamethasone for patients with COVID-19 and non-critical respiratory failure. Further evaluation of this combination therapy is needed.Clinical Trial RegistrationJapan Registry of Clinical Trials (jRCT) identifier jRCTs041200025.
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15 schema:keywords COVID-19
16 COVID-19 outcomes
17 ConclusionThe
18 IBW/day
19 MethodsWe
20 ResultsSixty-nine patients
21 administration
22 adverse events
23 agents
24 antiviral agents
25 body weight
26 clinical trials
27 combination therapy
28 common grade
29 corticosteroids
30 criteria
31 critical respiratory failure
32 days
33 death
34 dexamethasone
35 efficacy
36 efficacy of dexamethasone
37 endpoint
38 evaluation
39 events
40 evidence
41 factors
42 failure
43 failure progression
44 favipiravir
45 favorable levels
46 findings
47 first day
48 further evaluation
49 grade
50 history
51 hyperglycemia
52 ideal body weight
53 initiation
54 intubation
55 key strategy
56 levels
57 mechanical ventilation
58 methylprednisolone
59 mortality
60 multicenter
61 objective
62 outcomes
63 patients
64 phase
65 phase II clinical trial
66 primary endpoint
67 progression
68 proportion
69 proportion of patients
70 recovery trials
71 registry
72 respiratory failure
73 respiratory failure progression
74 risk factors
75 safety
76 significant risk factors
77 single-arm phase
78 smoking history
79 strategies
80 study
81 study treatment
82 systemic corticosteroids
83 therapy
84 threshold
85 total
86 tracheal intubation
87 treatment
88 treatment initiation
89 treatment-related adverse events
90 trials
91 ventilation
92 weight
93 schema:name Phase II Clinical Trial of Combination Therapy with Favipiravir and Methylprednisolone for COVID-19 with Non-Critical Respiratory Failure
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