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1.
Japanese Journal of Thrombosis and Hemostasis ; 32(6):2021_JJTH_32_6_726-730, 2021.
Article in Japanese | J-Stage | ID: covidwho-1581445
2.
Int J Infect Dis ; 115: 218-223, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1560942

ABSTRACT

OBJECTIVES: Favipiravir is an antiviral that is being evaluated for the treatment of COVID-19. Use of favipiravir is associated with elevation of serum uric acid levels. Risk factors for the occurrence of hyperuricemia are unclear. METHODS: Specimens from COVID-19 patients who received 10 days of favipiravir in a previous clinical trial (jRCTs041190120) were used. Serum favipiravir concentrations were measured by LC-MS. Factors associated with the development of hyperuricemia were investigated using logistic regression analysis. Optimal cut-off values for the baseline serum uric acid levels and steady-state serum favipiravir concentrations in predicting the occurrence of hyperuricemia were determined by ROC curve analysis. RESULTS: Among the 66 COVID-19 patients who were treated with favipiravir for 10 days, the steady-state serum favipiravir concentrations were significantly correlated with serum uric acid levels. High baseline serum uric acid levels and steady-state serum favipiravir concentrations during therapy were factors associated with the development of hyperuricemia. The cut­off baseline serum uric acid level and steady-state serum favipiravir concentration during favipiravir administration determined to predict hyperuricemia were 3.7 mg/dL and 46.14 µg/mL, respectively. CONCLUSIONS: Patients with high baseline serum uric acid levels or who achieved high steady-state serum favipiravir concentrations during therapy were susceptible to hyperuricemia.


Subject(s)
COVID-19 , Hyperuricemia , Amides , Humans , Hyperuricemia/drug therapy , Pyrazines , SARS-CoV-2 , Uric Acid
3.
Open Forum Infect Dis ; 8(10): ofab497, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1526186

ABSTRACT

The incidence of delayed injection site reaction after the first dose of mRNA-1273 vaccine was 12.5% among females and 1.5% among males in a cohort of primarily elderly Japanese. After the second dose, 48.4% of those who could be contacted reported recurrence. The reaction may be relatively common among Asian females.

4.
Emerging Infectious Diseases ; 27(10), 2021.
Article in English | ProQuest Central | ID: covidwho-1505885

ABSTRACT

The US–Japan Cooperative Medical Sciences Program, a 56-year-old bilateral program, has convened the International Conferences on Emerging Infectious Diseases in the Pacific Rim in different countries in the Asia–Pacific region since 1996 (1,2). Because of the ongoing pandemic, the annual conference could not convene in person. In a presentation that outlined the serologic characteristic of SARS-CoV-2 infection and the latest technologic advances aimed at increasing sensitivity and specificity of viral infection diagnostics, the speaker noted the importance of considering the disease prevalence and the influence of factors, such as age and disease severity, among different groups within a population in developing assay platforms, and a need for the development of SARS-CoV-2–specific IgA diagnostic tests. Google Scholar Yohei Doi, Ken Ishii, Akira Nishizono, Asuka Nanbo, Shuzo Urata, Ichiro Kurane, Jules Carl Celebrado, John Philip Depatillo, Zymar Bandola, Diane E. Griffin, Eun-Chung Park, David McDonald, Kristina Lu, K. Gayle Bernabe , and Gray Handley Fujita Health University School of Medicine, Toyoake, Japan (Y. Doi);University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA (Y. Doi);University of Tokyo, Tokyo, Japan (K. Ishii);Oita University Faculty of Medicine, Oita, Japan (A. Nishizono);National Research Center for the Control and Prevention of Infectious Diseases, Nagasaki University, Nagasaki, Japan (A. Nanbo, S. Urata);National Institute of Infectious Diseases, Tokyo (I. Kurane);Department of Science and Technology, Manila, Philippines (J.C. Celebrado, J.P. Depatillo, Z. Bandola);Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA (D.E. Griffin);National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA (E.-C.

6.
Infect Dis Ther ; 10(4): 2353-2369, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1347449

ABSTRACT

INTRODUCTION: The 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. METHODS: We 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). RESULTS: Sixty-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%. CONCLUSION: The 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 REGISTRATION: Japan Registry of Clinical Trials (jRCT) identifier jRCTs041200025.

7.
Heliyon ; 6(9): e04929, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-1343228

ABSTRACT

Background: Several immunochromatographic serological test kits have been developed to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific antibodies, but their relative performance and potential clinical utility is unclear. Methods: Three commercially available serological test kits were evaluated using 99 serum samples collected from 29 patients diagnosed with coronavirus disease 2019 (COVID-19) and 100 serum samples collected from 100 healthy volunteers in 2017 as negative controls. Results: The specificity of the IgM and IgG antibodies showed comparable results among the three immunochromatographic serological test kits. The specificity for IgM antibody was 98.0%, 98.0%, and 97.0%, and the specificity for IgG antibody was identical among the three kits (99.0%). The IgM antibody-positive rates of the three test kits for samples taken at the early stage of the disease (0-4 days after onset) were consistent with all three kits (18.2%); however, the IgM antibody-positive rates thereafter showed considerable differences among the kits, making it difficult to interpret the kinetics of IgM response against SARS-CoV-2. The IgG antibody-positive rates for samples taken after 13 days of onset were 100.0%, 97.6%, and 97.6%, respectively. Conclusion: There were large differences among the results of the three test kits. Only few cases showed positive results for IgM, suggesting that at least 2 of these kits used in this study were unsuitable for diagnosis of COVID-19. The IgG antibody was positive in almost all samples after 13 days of onset, suggesting that it may be useful for determining infections in the recent past.

8.
Infect Control Hosp Epidemiol ; 42(7): 864-868, 2021 07.
Article in English | MEDLINE | ID: covidwho-1316684

ABSTRACT

Rapid diagnostic testing (RDT) can provide prompt, accurate identification of infectious organisms and be a key component of antimicrobial stewardship (AMS) programs. However, their use is less widespread in Asia Pacific than western countries. Cost can be prohibitive, particularly in less resource-replete settings. A selective approach is required, possibly focusing on the initiation of antimicrobials, for differentiating bacterial versus viral infections and identifying locally relevant tropical diseases. Across Asia Pacific, more data are needed on RDT use within AMS, focusing on the impact on antimicrobial usage, patient morbidity and mortality, and cost effectiveness. Moreover, in the absence of formal guidelines, regional consensus statements to guide clinical practice are warranted. These will provide a regionally relevant definition for RDT; greater consensus on its role in managing infections; advice on implementation and overcoming barriers; and guidance on optimizing human resource capacity. By addressing these issues, the outcomes of AMS programs should improve.


Subject(s)
Anti-Infective Agents , Antimicrobial Stewardship , Anti-Bacterial Agents/therapeutic use , Anti-Infective Agents/therapeutic use , Asia , Diagnostic Techniques and Procedures , Humans
9.
J Infect Chemother ; 27(9): 1350-1356, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1267752

ABSTRACT

INTRODUCTION: Several clinical studies have reported the efficacy of favipiravir in reducing viral load and shortening the duration of symptoms. However, the viability of SARS-CoV-2 in the context of favipiravir therapy and the potential for resistance development is unclear. METHODS: We sequenced SARS-CoV-2 in nasopharyngeal specimens collected from patients who participated in a randomized clinical trial of favipiravir at hospitals across Japan between March and May 2020. Paired genomes were sequenced from those who remained RT-PCR-positive 5-8 days into favipiravir therapy. Daily nasopharyngeal specimens from 69 patients who were RT-PCR-positive at randomization were examined for a cytopathic effect (CPE). RESULTS: Some strains early in the trial belonged to clade 19 B, whereas the majority belonged to clade 20 B. The median time from the disease onset to negative CPE was 9 days. CPE was strongly correlated with the time from disease onset, viral load, age, and male sex. Among 23 patients for whom paired genomes were available, all except one had identical genomes. Two mutations were observed in one patient who received favipiravir, neither in the RdRp gene. CONCLUSIONS: The SARS-CoV-2 genome distribution in this clinical trial conducted in Japan reflected the early influx of strains from China followed by replacement by strains from Europe. CPE was significantly associated with age, male sex, and viral loads but not with favipiravir therapy. There was no evidence of resistance development during favipiravir therapy.


Subject(s)
COVID-19 , SARS-CoV-2 , Amides , Antiviral Agents/therapeutic use , China , Europe , Genomics , Humans , Japan , Male , Pyrazines , Treatment Outcome
10.
mSphere ; 6(3)2021 05 19.
Article in English | MEDLINE | ID: covidwho-1236421

ABSTRACT

Information regarding the infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in asymptomatic carriers is scarce. In order to determine the duration of infectivity and its correlation with reverse transcription-PCR (RT-PCR) results and time since initial positive PCR test in this population, we evaluated SARS-CoV-2 cell infectivity in nasopharyngeal samples longitudinally obtained from asymptomatic carriers who disembarked from a cruise ship during a COVID-19 outbreak. Of 166 nasopharyngeal samples collected from 39 asymptomatic carriers every 48 h until two consecutive negative PCR test results were obtained, SARS-CoV-2 was successfully isolated from 9 PCR-positive samples which were obtained from 7 persons (18%; 7/39). Viable viruses were isolated predominantly within 7 days after the initial positive PCR test, except for one person who shed viable virus until day 15. The median crossing point (Cp) value of RT-PCR of culture-positive samples was 24.6 (interquartile range [IQR], 20.4 to 25.8; range, 17.9 to 30.3), and Cp values were significantly associated with isolation of viable virus (odds ratio, 0.496; 95% confidence interval [CI], 0.329 to 0.747; P value, 0.001), which was consistent with existing data for symptomatic patients. Genome sequence analysis of SARS-CoV-2 samples consecutively obtained from a person who shed viable virus for 15 days identified the emergence of two novel single nucleotide variants (C8626T transition and C18452T transition) in the sample collected on day 15, with the latter corresponding to an amino acid substitution in nonstructural protein 14. The impact of these mutations on prolonged viable-virus shedding is unclear. These findings underscore the potential role of asymptomatic carriers in transmission.IMPORTANCE A growing number of studies suggest the potential role of asymptomatic SARS-CoV-2 carriers as a major driver of the COVID-19 pandemic; however, virological assessment of asymptomatic infection has largely been limited to reverse transcription-PCR (RT-PCR), which can be persistently positive without necessarily indicating the presence of viable virus (e.g., replication-competent virus). Here, we evaluated the infectivity of asymptomatic SARS-CoV-2 carriers by detecting SARS-CoV-2-induced cytopathic effects on Vero cells using longitudinally obtained nasopharyngeal samples from asymptomatic carriers. We show that asymptomatic carriers can shed viable virus until 7 days after the initial positive PCR test, with one outlier shedding until day 15. The crossing point (Cp) value of RT-PCR was the leading predictive factor for virus viability. These findings provide additional insights into the role of asymptomatic carriers as a source of transmission and highlight the importance of universal source control measures, along with isolation policy for asymptomatic carriers.


Subject(s)
Asymptomatic Infections/epidemiology , COVID-19/transmission , Virus Shedding/physiology , Adolescent , Adult , Aged , Animals , COVID-19 Nucleic Acid Testing/methods , Cell Line , Child , Chlorocebus aethiops , Female , Genome, Viral/genetics , Humans , Male , Middle Aged , Nasopharynx/virology , SARS-CoV-2/genetics , Vero Cells , Whole Genome Sequencing , Young Adult
11.
Clin Infect Dis ; 72(10): e458-e459, 2021 05 18.
Article in English | MEDLINE | ID: covidwho-1232183
12.
J Immunol ; 206(10): 2393-2401, 2021 05 15.
Article in English | MEDLINE | ID: covidwho-1215527

ABSTRACT

Serological tests for detection of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Abs in blood are expected to identify individuals who have acquired immunity against SARS-CoV-2 and indication of seroprevalence of SARS-CoV-2 infection. Many serological tests have been developed to detect Abs against SARS-CoV-2. However, these tests have considerable variations in their specificity and sensitivity, and whether they can predict levels of neutralizing activity is yet to be determined. This study aimed to investigate the kinetics and neutralizing activity of various Ag-specific Ab isotypes against SARS-CoV-2 in serum of coronavirus disease 2019 (COVID-19) patients confirmed via PCR test. We developed IgG, IgM, and IgA measurement assays for each Ag, including receptor-binding domain (RBD) of spike (S) protein, S1 domain, full-length S protein, S trimer, and nucleocapsid (N) domain, based on ELISA. The assays of the S protein for all isotypes showed high specificity, whereas the assays for all isotypes against N protein showed lower specificity. The sensitivity of all Ag-specific Ab isotypes depended on the timing of the serum collection and all of them, except for IgM against N protein, reached more than 90% at 15-21 d postsymptom onset. The best correlation with virus-neutralizing activity was found for IgG against RBD, and levels of IgG against RBD in sera from four patients with severe COVID-19 increased concordantly with neutralizing activity. Our results provide valuable information regarding the selection of serological test for seroprevalence and vaccine evaluation studies.


Subject(s)
Antibodies, Neutralizing/immunology , Antibodies, Viral/immunology , Antibody Specificity , Antigens, Viral/immunology , COVID-19/immunology , Immunoglobulin Isotypes/immunology , SARS-CoV-2/immunology , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/diagnosis , COVID-19 Nucleic Acid Testing , Female , Humans , Male , Middle Aged
13.
JPRN; 23/04/2021; TrialID: JPRN-jRCT2041210013
Clinical Trial Register | ICTRP | ID: ictrp-JPRN-jRCT2041210013

ABSTRACT

Condition:

Prevention for SARS-CoV-2 infection disease

Intervention:

Injection of EXG-5003 or placebo

Primary outcome:

Humoral immune response
-Anti-RBD antibody titers
-Neutralizing antibody titers methods
Cellular immune response
-FluoroSpot Assay
- Intracellular cytokine staining assay

Criteria:

Inclusion criteria: -Has provided written consent for participation
-Age between 20 and 55
-Has a negative nucleic acid-based test result for SARS-CoV-2
-Has a negative antibody test result for SARS-CoV-2

Exclusion criteria: -Presence of uncontrolled cardiovascular, hemetologic, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disease
-Presence of diabetes mellitus
-Presence of active autoimmune disease
-Positive for HBc, HCV or HIV antibody
-History of anaphylactic shock
-History of epilepsy
-Presence of active malignancy
-Presence of lung disase (e.g., COPD, asthma)
-Positive urine pregnancy test within 24 hours
-Pregnant or lactatingPlanned pregnancy of self (if female) or partner (if male) within 90 days after administration of the trial drug
-If female and premenopausal, not agreeable to contraception for 90 days after second administration of the trial drug
-If male, not agreeable to contraception for 90 days after second administration of the trial drug
-Prsence of clinically relevant electrocardiogram or vital sign abnormality at screening
-Participated in a clinical trial of a drug or a medical device within 30 days or a biologic within 90 days
-Rreceived any SARS-CoV-2 vaccine
-Received within 90 days, or is planning to receive during the study period, an immunoglobulin or blood product
-Received within 180 days, or is planning to receive during the study period, a biologic product with immunosuppressive properties
-Received for 14 days or more within 180 days, or is planning to receive during the study period, a corticosteroid
-Deemed ineligible for the study as determined by the principal investigator or a co-investigator

14.
Int J Infect Dis ; 107: 195-200, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1188630

ABSTRACT

OBJECTIVE: Reverse transcription loop-mediated isothermal amplification (RT-LAMP) has been validated to diagnose several viral infections. However, its diagnostic accuracy in detecting SARS-CoV-2 in real-life clinical settings remains unclear. This study aimed to determine the diagnostic sensitivity and specificity of RT-LAMP compared to reverse transcription-quantitative polymerase chain reaction (RT-qPCR) over the disease course of COVID-19. METHODS: A total of 124 nasopharyngeal swab samples obtained from 24 COVID-19 patients were tested by RT-LAMP and RT-qPCR. Sensitivities and specificities of RT-LAMP compared with RT-qPCR were analyzed as a function of time from onset. RESULTS: Up to the 9th day after onset, the RT-LAMP had a positivity of 92.8%, and the sensitivity and specificity compared with RT-qPCR was 100%. However, after the 10th day after onset, the positivity of RT-LAMP decreased to less than 25%, and the concordance of positivity between the two methods was below 60%. The limit of detection of RT-LAMP was 6.7 copies/reaction. CONCLUSIONS: Until the 9th day after the onset of symptoms, RT-LAMP had the same diagnostic accuracy as RT-qPCR. These findings suggest that RT-LAMP can be used as a diagnostic tool for COVID-19 as an alternative to RT-qPCR in the acute symptomatic phase of COVID-19.


Subject(s)
COVID-19 Nucleic Acid Testing/methods , COVID-19 Testing , COVID-19/diagnosis , Molecular Diagnostic Techniques/methods , Nucleic Acid Amplification Techniques/methods , SARS-CoV-2 , Adult , Female , Humans , Male , Middle Aged , Sensitivity and Specificity
15.
Emerg Infect Dis ; 27(3): 919-923, 2021 03.
Article in English | MEDLINE | ID: covidwho-1030276

ABSTRACT

Postmortem lung pathology of a patient in Japan with severe acute respiratory syndrome coronavirus 2 infection showed diffuse alveolar damage as well as bronchopneumonia caused by Streptococcus pneumoniae infection. The distribution of each pathogen and the accompanying histopathology suggested the infections progressed in a mutually exclusive manner within the lung, resulting in fatal respiratory failure.


Subject(s)
COVID-19/pathology , Coinfection , Lung , Pneumococcal Infections/pathology , Aged, 80 and over , Autopsy , Humans , Lung/microbiology , Lung/pathology , Lung/virology , Male , SARS-CoV-2/isolation & purification , Streptococcus pneumoniae/isolation & purification
16.
The Journal of the Japanese Society of Internal Medicine ; 109(11):2319-2322, 2020.
Article in Japanese | WHO COVID | ID: covidwho-946721

ABSTRACT

The novel coronavirus spread from China to the rest of the world, and a major pandemic has followed. In developing treatments for coronavirus disease 2019 (COVID-19), drug repositioning of existing drugs with antiviral activity has been the main focus, and s uppression of hyperimmunity is also a major theme in severe cases. Although the treatment for COVID-19 is still in its infancy, knowledge based on clinical and other studies is accumulating at an unprecedented rate.

17.
Antimicrob Agents Chemother ; 64(12)2020 11 17.
Article in English | MEDLINE | ID: covidwho-939841

ABSTRACT

Favipiravir is an oral broad-spectrum inhibitor of viral RNA-dependent RNA polymerase that is approved for treatment of influenza in Japan. We conducted a prospective, randomized, open-label, multicenter trial of favipiravir for the treatment of COVID-19 at 25 hospitals across Japan. Eligible patients were adolescents and adults admitted with COVID-19 who were asymptomatic or mildly ill and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients were randomly assigned at a 1:1 ratio to early or late favipiravir therapy (in the latter case, the same regimen starting on day 6 instead of day 1). The primary endpoint was viral clearance by day 6. The secondary endpoint was change in viral load by day 6. Exploratory endpoints included time to defervescence and resolution of symptoms. Eighty-nine patients were enrolled, of whom 69 were virologically evaluable. Viral clearance occurred within 6 days in 66.7% and 56.1% of the early and late treatment groups (adjusted hazard ratio [aHR], 1.42; 95% confidence interval [95% CI], 0.76 to 2.62). Of 30 patients who had a fever (≥37.5°C) on day 1, times to defervescence were 2.1 days and 3.2 days in the early and late treatment groups (aHR, 1.88; 95% CI, 0.81 to 4.35). During therapy, 84.1% developed transient hyperuricemia. Favipiravir did not significantly improve viral clearance as measured by reverse transcription-PCR (RT-PCR) by day 6 but was associated with numerical reduction in time to defervescence. Neither disease progression nor death occurred in any of the patients in either treatment group during the 28-day participation. (This study has been registered with the Japan Registry of Clinical Trials under number jRCTs041190120.).


Subject(s)
Amides/administration & dosage , Antiviral Agents/administration & dosage , COVID-19/drug therapy , Pyrazines/administration & dosage , SARS-CoV-2/drug effects , Viral Load/drug effects , Adolescent , Adult , Amides/adverse effects , Antiviral Agents/adverse effects , Asymptomatic Diseases , COVID-19/physiopathology , COVID-19/virology , Female , Hospitalization , Humans , Hyperuricemia/chemically induced , Hyperuricemia/diagnosis , Hyperuricemia/physiopathology , Japan , Male , Middle Aged , Prospective Studies , Pyrazines/adverse effects , Random Allocation , SARS-CoV-2/pathogenicity , Secondary Prevention/organization & administration , Severity of Illness Index , Time-to-Treatment/organization & administration , Treatment Outcome
19.
JPRN; 02/03/2020; TrialID: JPRN-jRCTs041190120
Clinical Trial Register | ICTRP | ID: ictrp-JPRN-jRCTs041190120

ABSTRACT

Condition:

COVID-19 infection
COVID-19 infection

Intervention:

Immediate favipiravir arm: Favipiravir administered orally between Day 1 and Day 10, 1800 mg twice a day on Day 1 followed by 800 mg twice a day from Day 2
Delayed favipiravir arm: Favipiravir administered orally between Day 6 and Day 15, 1800 mg twice a day on Day 6 followed by 800 mg twice a day from Day 7

Primary outcome:

Proportion of subjects with clearance of SARS-CoV2 in nasopharyngeal swab by Day 6

Criteria:

Inclusion criteria: (1) Age 16 or greater at the time of consent
(2) Sex; male or female
(3) Outpatient or inpatient: inpatient
(4) Meets all of 1), 2), 3) below
1)Has at least one RT-PCR test positive for SARS-CoV2 from pharyngeal or nasopharyngeal swab (date of collection must be within 14 days before enrollment)
2) Has a performance status of 0 or 1
3) Is able to remain inpatient for 6 days
(5) Has a negative pregnancy test if the subject is female and pre-menopausal
(6) Has provided written consent for participation; written consents from both the subject and a legal guardian

Exclusion criteria: (1) Performance status of 2 or greater
(2) Advanced liver function abnormalities classified as grade C by the Child-Pugh criteria
(3) End-stage renal disease requiring dialysis
(4) Altered mental status
(5) Pregnant or planning pregnancy
(6) If female, not agreeable to using oral contraceptive, intrauterine contraceptive device, mechanical contraceptive methods such as pessaries and condoms, or combinations thereof, during favipiravir administration and 90 days thereafter
(7) If male, has a female partner who is not agreeable to the contraceptive methods described in (7)
(8) If male, not agreeable to using condoms during favipiravir administration and 90 days thereafter
(9) History of hereditary xanthine oxidase deficiency
(10) History of hypouricemia (less than 1 mg/dL) or xanthine urolithiasis
(11) History of uncontrolled gout or hyperuricemia
(12) History of immunocompromising conditions such as HIV positivity
(13) Has received systemic agents with suggested activity against SARS-CoV2 within 28 days before enrollment
(14) Deemed ineligible as determined by the principal investigator or a co-investigator

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