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1.
EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-332338

ABSTRACT

ABSTRACT Background In vitro drug-screening studies have indicated that camostat mesilate (FOY-305) may prevent SARS-CoV-2 infection into human airway epithelial cells. This study was conducted to investigate whether camostat mesilate is an effective treatment for SARS-CoV-2 infection (COVID-19). Methods This was a phase 3, multicentre, double-blind, randomised, parallel-group, placebo-controlled study. Patients were enrolled if they were admitted to a hospital within 5 days of onset of COVID-19 symptoms or within 5 days of a positive test for asymptomatic patients. Severe cases (e.g., those requiring oxygenation/ventilation) were excluded. Patients were administered camostat mesilate (600 mg qid;four to eight times higher than the clinical doses in Japan) or placebo for up to 14 days. The primary efficacy endpoint was the time to the first two consecutive negative tests for SARS-CoV-2. Findings One-hundred and fifty-five patients were randomised to receive camostat mesilate (n=78) or placebo (n=77). The median time to the first test was 11 days in both groups, and conversion to negative status was observed in 60·8% and 63·5% of patients in the camostat mesilate and placebo groups, respectively. The primary (Bayesian) and secondary (frequentist) analyses found no significant differences in the primary endpoint between the two groups. No additional safety concerns beyond those already known for camostat mesilate were identified. Interpretation Camostat mesilate is no more effective, based on upper airway viral clearance, than placebo for treating patients with mild to moderate SARS-CoV-2 infection with or without symptoms. Funding Ono Pharmaceutical Co., Ltd. RESEARCH IN CONTEXT PANEL Evidence before this study SARS-CoV-2 infection (COVID-19), as a significant global health threat, is characterised by broad symptoms and varying disease severity. At the time of planning this study, there were no specific treatments for COVID-19 beyond the use of antiviral drugs, steroids and, in severe cases, ventilation with oxygen. Pre-clinical screening studies revealed the spike (S) protein of SARS-CoV-2 bind to angiotensin converting enzyme II (ACE2) on the host cell membrane. The S protein is then cleaved by a type II transmembrane serine protease (TMPRSS2) as an essential enzyme for the viral entry into host cells. In vitro drug-screening studies have shown that drugs that block binding of the S protein to ACE2 can prevent viral entry into a cell line derived from human airway epithelium. The studies identified 4-(4-guanidinobenzoyloxy)phenylacetic acid, the active metabolite of a serine protease inhibitor (camostat mesilate, FOY-305), as a candidate inhibitor of SARS-CoV-2 entry into humans. A retrospective study of critically ill COVID-19 patients with organ failure revealed a decline in disease activity within 8 days of admission among patients treated with camostat mesilate. In consideration of the preclinical and early clinical evidence, it was hypothesised that camostat mesilate is an effective treatment for patients with COVID-19. Therefore, we planned and executed a phase 3, randomised, double-blind, placebo-controlled study to investigate the efficacy and safety of camostat mesilate for the treatment of patients with mild to moderate COVID-19 infection with or without symptoms. The primary endpoint was the time to the first two consecutive negative tests for SARS-CoV-2. No controlled clinical studies of camostat mesilate had been conducted at the time of planning this study. Added value of this study The results of this randomised controlled trial revealed that camostat mesilate, administered at a dose of 600 mg qid for up to 14 days, was no more effective than placebo, based on upper airway viral clearance in patients with mild to moderate SARS-CoV-2 infection with or without symptoms. Furthermore, there were no differences between the study groups in terms of other efficacy endpoints. This study used a dose that was four to eight tim s higher than the clinical doses of camostat mesilate used in Japan for the acute symptoms of chronic pancreatitis and postoperative reflux oesophagitis. The study identified no additional safety concerns beyond those already known for camostat mesilate. Implications of all available evidence After starting this study, another randomised, placebo-controlled study reported the efficacy and safety of camostat mesilate for the treatment of patients with COVID-19, albeit at a lower dose of 200 mg three times daily. That study also found no difference between camostat mesilate and placebo for the primary endpoint (the time to discharge or a clinical improvement in clinical severity of at least two points on a seven-point ordinal scale). Along with this evidence, our study did not support the use of camostat mesilate as a treatment option for COVID-19. However, since the administration of camostat mesilate was started after the onset of symptoms and presumably the peak viral load, we cannot exclude the possibility that camostat mesilate may be effective if administration is started earlier in the course of infection, or perhaps as prophylactic use in close contacts.

2.
Viruses ; 14(4):670, 2022.
Article in English | MDPI | ID: covidwho-1762631

ABSTRACT

The effect of treatment with favipiravir, an antiviral purine nucleoside analog, for coronavirus disease 2019 (COVID-19) on the production and duration of neutralizing antibodies for SARS-CoV-2 was explored. There were 17 age-, gender-, and body mass index-matched pairs of favipiravir treated versus control selected from a total of 99 patients recovered from moderate COVID-19. These subjects participated in the longitudinal (>6 months) analysis of (i) SARS-CoV-2 spike protein's receptor-binding domain IgG, (ii) virus neutralization assay using authentic virus, and (iii) neutralization potency against original (WT) SARS-CoV-2 and cross-neutralization against B.1.351 (beta) variant carrying triple mutations of K417N, E484K, and N501Y. The results demonstrate that the use of favipiravir: (1) significantly accelerated the elimination of SARS-CoV-2 in the case vs. control groups (p = 0.027), (2) preserved the generation and persistence of neutralizing antibodies in the host, and (3) did not interfere the maturation of neutralizing potency of anti-SARS-CoV-2 and neutralizing breadth against SARS-CoV-2 variants. In conclusion, treatment of COVID-19 with favipiravir accelerates viral clearance and does not interfere the generation or maturation of neutralizing potency against both WT SARS-CoV-2 and its variants.

3.
EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-329837

ABSTRACT

In this randomized, observer-blinded, phase 2/3 study, we assessed S-268019-b—a recombinant spike protein vaccine. We analyzed the noninferiority of S-268019-b (n=103), versus tozinameran (n=103), when given as a booster ≥6 months after the 2-dose tozinameran regimen in Japanese adults without prior COVID-19 infection. Interim results showed that S-268019-b was noninferior to tozinameran in co-primary endpoints: geometric mean titer (GMT) (126.42 versus 108.20;adjusted-GMT ratio [95% CI], 1.17 [0.96-1.42];noninferiority P -value, <0.0001) and seroresponse rate (both 100%;noninferiority P -value, 0.0004) for neutralizing antibodies on day 29. Both vaccines elicited anti-spike protein immunoglobulin G antibodies, and produced T-cell response (n=30/group) and neutralized Delta and Omicron pseudovirus variants (n=24/group) in subgroups. Most participants reported low-grade reactogenicity on days 1 and 2, the most frequent being fatigue, fever, myalgia, and injection-site pain. No serious adverse events were reported. S-268019-b safety and robust immunogenicity as a booster, supporting its use as COVID-19 booster vaccine. JRCT ID jRCT2031210470 Highlights Third COVID-19 vaccine dose (booster) enhances immune response Interim phase 2/3 data for booster ≥6 months after the 2nd dose in Japan are shown S-268019-b and tozinameran were safe and equal in inducing neutralizing antibodies Both boosters neutralized Delta and Omicron pseudovirus and induced T-cell response Results: support use of S-268019-b as a booster in vaccinated adults

4.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-312933

ABSTRACT

Background: Corticosteroids use in coronavirus disease 2019 (COVID-19) is controversial, especially in mild to severe patients who do not require invasive/noninvasive ventilation. Moreover, many factors remain unclear regarding the appropriate use of corticosteroids for COVID-19. In this context, this multicenter, retrospective, propensity score–matched study was launched to evaluate the efficacy of systemic corticosteroid administration for hospitalized patients with COVID-19 ranging in the degree of severity from mild to critically-ill disease. Methods: : This multicenter, retrospective study enrolled consecutive hospitalized COVID-19 patients diagnosed January–April 2020 across 30 institutions in Japan. Clinical outcomes were compared for COVID-19 patients who received or did not receive corticosteroids, after adjusting for propensity scores. The primary endpoint was the odds ratio (OR) for improvement on a 7-point ordinal score on Day 15. Results: : Of 1092 COVID-19 patients analyzed, 118 patients were assigned to either the corticosteroid and non-corticosteroid group, after propensity score matching. At baseline, most patients did not require invasive/noninvasive ventilation (85.6% corticosteroid group vs. 89.8% non-corticosteroid group). The odds of improvement in a 7-point ordinal score on Day 15 was significantly lower for the corticosteroid versus non-corticosteroid group (OR, 0.611;95% confidence interval [CI], 0.388–0.962;p = 0.034). The time to improvement in radiological findings was significantly shorter in the corticosteroid versus non-corticosteroid group (hazard ratio [HR], 1.758;95% CI, 1.323–2.337;p < 0.001), regardless of baseline clinical status. The duration of invasive mechanical ventilation was shorter in corticosteroid versus non-corticosteroid group (HR, 1.466;95% CI, 0.841–2.554;p = 0.177). Of the 106 patients who received methylprednisolone, the duration of invasive mechanical ventilation was significantly shorter in the pulse/semi-pulse versus standard dose group (HR, 2.831;95% CI, 1.347–5.950;p = 0.006). Conclusions: : Corticosteroids for hospitalized patients with COVID-19 did not improve clinical status on Day 15, but reduced the time to improvement in radiological findings for all patients regardless of disease severity and also reduced the duration of invasive mechanical ventilation in patients who required intubation. Trial registration : This study was registered in the University hospital Medical Information Network Clinical Trials Registry on April 21, 2020 (ID: UMIN000040211).

5.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-296006

ABSTRACT

Introduction: Blood tests and computed tomography (CT) findings at diagnosis are widely used in daily clinical practice and can offer useful prognostic factors for coronavirus disease 2019. Methods: : We retrospectively evaluated 66 patients who underwent a blood test and CT between January 1 and May 31, 2020, and performed a propensity score-matched case-control study. Cases and controls were a severe respiratory failure group (non-rebreather mask, nasal high-flow, positive-pressure ventilation) and a non-severe respiratory failure group, matched at a ratio of 1:3 by propensity scores constructed by age, sex, and medical history. We compared groups for maximum body temperature up to diagnosis, laboratory findings, and CT findings in the matched cohort. Two-tailed P-values <0.05 were considered statistically significant. Results: : Nine cases and 27 controls were included in the matched cohort. Significant differences were seen in maximum body temperature up to diagnosis (p=0.0043), the number of shaded lobes (p=0.0434), amount of ground-glass opacity (GGO) in the total lung field (p=0.0071), amounts of GGO (p=0.0001), and consolidation (p=0.0036) in the upper lung field, and pleural effusion (p=0.0117). Conclusions: : Fever and CT findings (such as GGO and consolidation) may be prognostic indicators that can be easily measured at diagnosis.

6.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-292710

ABSTRACT

Amid pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), vaccination is hailed as one of the most effective preventive measures. An mRNA vaccine termed BNT162b2 showed satisfactory safety and efficacy in the clinical trials but several issues including variability in the individual immune response or determination of target antibody titre that exerts sufficient immune protection needs to be assessed for planning a more efficient vaccination strategy. By monitoring IgG titres before and two months after the initial administration of BNT162b2 in 655 healthcare workers by Abbott IgG II quant that detects IgG against the receptor-binding domain in S protein of SARS-CoV-2, we confirmed that hypertension, dyslipidaemia, chronic kidney disease and use of immune suppressant in addition to male gender, advanced age, and absence of previous infection were significantly associated with low antibody response to the vaccination.

7.
J Microbiol Immunol Infect ; 2021 Sep 29.
Article in English | MEDLINE | ID: covidwho-1440211

ABSTRACT

BACKGROUND: Exact comprehension of the prevalence of SARS-CoV-2 infection is essential for the preventive measures. In the clinical settings, however, patients infected with SARS-CoV-2 may not be fully detected by PCR. In the long-term prevalence study, cut-off of IgG assay may not be appropriate due to waning IgG titer. METHODS: 24 PCR-negative subjects suspected of COVID-19 were categorized into cohorts termed "presumed COVID-19 positive" and "presumed COVID-19 negative" by chest CT images. IgG against nucleocapsid protein of SARS-CoV-2 (IgG (N)) and IgG against receptor biding domain of SARS-CoV-2 (IgG (RBD)) were measured in sera of the subjects and the concordance with the cohort categorization was assessed by receiver operating characteristics (ROC) analyses. RESULTS: Area under the curves (AUC's) by the ROC analyses with the 24 subjects were 0.982 with IgG (N) and 0.854 with IgG (RBD). Even when we excluded the subjects whose initial PCR was performed after five days from symptom onset, the AUC's were 0.967 with IgG (N) and 0.800 with IgG (RBD). The ROC analysis indicated 0.2 S/C as the optimum cut-off forIgG (N). CONCLUSION: Both IgG (N) and IgG (RBD) titers were significantly elevated in subjects whose PCR never showed positive but suggestive of SARS-CoV-2 infection, which indicated the necessity of serological tests in complementing the shortcomings of PCR. For a long-term prevalence study, a cut-off lower than the one used in the ongoing infection phase (e.g. 0.2 S/C vs. 1.4 S/C) was indicated to be more appropriate for IgG (N).

8.
Infect Dis Ther ; 10(4): 2489-2509, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1375855

ABSTRACT

INTRODUCTION: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), is an enveloped, single-stranded RNA virus. Favipiravir is an orally administrable antiviral drug whose mechanism of action is to selectively inhibit RNA-dependent RNA polymerase. A preliminary trial in COVID-19 patients reported significant improvements across a multitude of clinical parameters, but these findings have not been confirmed in an adequate well-controlled trial. We conducted a randomized, single-blind, placebo-controlled Phase III trial assessing the efficacy and safety of favipiravir in patients with moderate pneumonia not requiring oxygen therapy. METHODS: COVID-19 patients with moderate pneumonia (SpO2 ≥ 94%) within 10 days of onset of fever (temperature ≥ 37.5 °C) were assigned to receive either placebo or favipiravir (1800 mg twice a day on Day 1, followed by 800 mg twice a day for up to 13 days) in a ratio of 1:2. An adaptive design was used to re-estimate the sample size. The primary endpoint was a composite outcome defined as the time to improvement in temperature, oxygen saturation levels (SpO2), and findings on chest imaging, and recovery to SARS-CoV-2-negative. This endpoint was re-examined by the Central Committee under blinded conditions. RESULTS: A total of 156 patients were randomized. The median time of the primary endpoint was 11.9 days in the favipiravir group and 14.7 days in the placebo group, with a significant difference (p = 0.0136). Favipiravir-treated patients with known risk factors such as obesity or coexisting conditions provided better effects. Furthermore, patients with early-onset in the favipiravir group showed higher odds ratio. No deaths were documented. Although adverse events in the favipiravir group were predominantly transient, the incidence was significantly higher. CONCLUSIONS: The results suggested favipiravir may be one of options for moderate COVID-19 pneumonia treatment. However, the risk of adverse events, including hyperuricemia, should be carefully considered. TRIAL REGISTRATION: Clinicaltrials.jp number: JapicCTI-205238.

9.
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.

10.
Sci Rep ; 11(1): 10727, 2021 05 21.
Article in English | MEDLINE | ID: covidwho-1238019

ABSTRACT

Corticosteroids use in coronavirus disease 2019 (COVID-19) is controversial, especially in mild to severe patients who do not require invasive/noninvasive ventilation. Moreover, many factors remain unclear regarding the appropriate use of corticosteroids for COVID-19. In this context, this multicenter, retrospective, propensity score-matched study was launched to evaluate the efficacy of systemic corticosteroid administration for hospitalized patients with COVID-19 ranging in the degree of severity from mild to critically-ill disease. This multicenter, retrospective study enrolled consecutive hospitalized COVID-19 patients diagnosed January-April 2020 across 30 institutions in Japan. Clinical outcomes were compared for COVID-19 patients who received or did not receive corticosteroids, after adjusting for propensity scores. The primary endpoint was the odds ratio (OR) for improvement on a 7-point ordinal score on Day 15. Of 1092 COVID-19 patients analyzed, 118 patients were assigned to either the corticosteroid and non-corticosteroid group, after propensity score matching. At baseline, most patients did not require invasive/noninvasive ventilation (85.6% corticosteroid group vs. 89.8% non-corticosteroid group). The odds of improvement in a 7-point ordinal score on Day 15 was significantly lower for the corticosteroid versus non-corticosteroid group (OR, 0.611; 95% confidence interval [CI], 0.388-0.962; p = 0.034). The time to improvement in radiological findings was significantly shorter in the corticosteroid versus non-corticosteroid group (hazard ratio [HR], 1.758; 95% CI, 1.323-2.337; p < 0.001), regardless of baseline clinical status. The duration of invasive mechanical ventilation was shorter in corticosteroid versus non-corticosteroid group (HR, 1.466; 95% CI, 0.841-2.554; p = 0.177). Of the 106 patients who received methylprednisolone, the duration of invasive mechanical ventilation was significantly shorter in the pulse/semi-pulse versus standard dose group (HR, 2.831; 95% CI, 1.347-5.950; p = 0.006). In conclusion, corticosteroids for hospitalized patients with COVID-19 did not improve clinical status on Day 15, but reduced the time to improvement in radiological findings for all patients regardless of disease severity and also reduced the duration of invasive mechanical ventilation in patients who required intubation.Trial registration: This study was registered in the University hospital Medical Information Network Clinical Trials Registry on April 21, 2020 (ID: UMIN000040211).


Subject(s)
Adrenal Cortex Hormones/administration & dosage , COVID-19/therapy , Hospitalization , Respiration, Artificial , SARS-CoV-2 , COVID-19/diagnostic imaging , COVID-19/pathology , Critical Illness , Female , Humans , Male , Middle Aged , Retrospective Studies
11.
Intern Med ; 60(1): 123-130, 2021.
Article in English | MEDLINE | ID: covidwho-1004553

ABSTRACT

Case 1: A 65-year-old man with novel coronavirus infection (COVID-19) complicated with acute respiratory failure. On admission, the patient was started on favipiravir and corticosteroid. However, due to a lack of significant improvement, he was introduced to mechanical ventilation and extracorporeal membrane oxygenation (ECMO). Although iliopsoas hematoma occurred as a complication, the patient recovered. Case 2: A 49-year-old man with COVID-19 had been started on favipiravir and corticosteroid. Due to progressive respiratory failure, the patient underwent mechanical ventilation and ECMO. The patient recovered without complications. We successfully treated these severe cases with a multimodal combination of pharmacological and non-pharmacological supportive therapy.


Subject(s)
Adrenal Cortex Hormones/therapeutic use , Amides/therapeutic use , Antiviral Agents/therapeutic use , COVID-19/therapy , Extracorporeal Membrane Oxygenation , Methylprednisolone/therapeutic use , Pyrazines/therapeutic use , Respiration, Artificial , Aged , COVID-19/complications , Humans , Male , Middle Aged , Respiratory Insufficiency/therapy , Respiratory Insufficiency/virology , SARS-CoV-2
12.
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
13.
Intern Med ; 60(1): 31-37, 2021 Jan 01.
Article in English | MEDLINE | ID: covidwho-902223

ABSTRACT

Objective We aimed to clarify clinical and laboratory characteristics of coronavirus disease 2019 (COVID-19) patients, and further explore the features to detect COVID-19 pneumonia at the first visit to community-based hospitals. Methods Diagnoses of COVID-19 were based on positive results from real-time reverse-transcription polymerase chain reaction testing of nasopharyngeal-swab specimens. We retrospectively reviewed the medical records of patients showing positive results. The clinical characteristics and results of blood tests were compared between the patients with and without pneumonia. The risk factors associated with pneumonia were then evaluated by a multivariable analysis. Results The study cohort comprised 154 patients, including 117 patients (76.0%) with pneumonia at first visit. Significant differences were seen in age, the frequency of fever, tachycardia, desaturation (peripheral oxygen saturation ≤95%), any comorbidity, neutrocyte count and fraction, lymphocyte count and fraction, platelet count, lactate dehydrogenase (LDH), C-reactive protein (CRP), and fibrinogen between the patients with and without pneumonia. Using a multivariable analysis, CRP ≥0.3 mg/dL and fibrinogen >400 mg/dL were found to be associated with the presence of pneumonia. Conclusion Community-based settings for screening COVID-19 patients should perform chest X-ray and blood tests for white blood cell fractions, fibrinogen, LDH, and CRP. Of these, elevations in the CRP and fibrinogen levels could be critically associated with the presence of COVID-19 pneumonia.


Subject(s)
COVID-19/diagnosis , Adult , Age Factors , C-Reactive Protein/analysis , COVID-19/blood , COVID-19 Nucleic Acid Testing , Female , Fever/virology , Fibrinogen/metabolism , Humans , Japan , L-Lactate Dehydrogenase/blood , Leukocyte Count , Lymphocyte Count , Male , Middle Aged , Neutrophils , Oximetry , Platelet Count , Retrospective Studies , Risk Factors , SARS-CoV-2 , Tachycardia/virology
14.
J Infect Chemother ; 27(2): 379-383, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-844273

ABSTRACT

A 49-year-old Japanese male was managed by mechanical ventilation due to coronavirus disease 2019 (COVID-19) pneumonia. Favipiravir as an antiviral therapy, and anti-inflammatory treatment were administered. SARS-CoV-2 RNA was detected in serum by the loop-mediated isothermal amplification (LAMP) method on Day 9; favipiravir treatment was continued. On Day 13, negative serum RNA was confirmed, followed by mechanical ventilation was removed. On Day 23, LAMP negative was confirmed in nasopharynx, after that the patient discharged on Day 27. We could treat successfully for severe COVID-19 pneumonia based on the LAMP method. We consider this method will be useful in COVID-19 treatment.


Subject(s)
Amides/administration & dosage , Antiviral Agents/administration & dosage , COVID-19/drug therapy , Pyrazines/administration & dosage , RNA, Viral/blood , SARS-CoV-2/isolation & purification , COVID-19/diagnosis , COVID-19 Testing/methods , Humans , Male , Middle Aged , Molecular Diagnostic Techniques/methods , Nasopharynx/virology , Nucleic Acid Amplification Techniques/methods , Pneumonia, Viral/drug therapy , RNA, Viral/isolation & purification , Respiration, Artificial/methods , Treatment Outcome , Viremia/diagnosis
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