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1.
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.

2.
J Dermatol ; 48(10): 1588-1592, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1319212

ABSTRACT

In the worldwide coronavirus disease 2019 (COVID-19) outbreak, skin manifestations were seen in COVID-19 patients. We report a case in which a COVID-19 patient developed cutaneous lesions that were diagnosed as erythema nodosum-like lesions, which were associated with COVID-19. Nasopharyngeal swab polymerase chain reaction (PCR) confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Histopathologically, extensive inflammation was seen from the epidermis to the fat tissue. An organized thrombus and disrupted inner elastic lamina were seen in an intradermal vessel. These findings suggest septal panniculitis with cutaneous polyarteritis nodosa. The results of PCR using the specimen of skin lesion was negative. The patient took non-steroidal anti-inflammatory drugs and the skin lesion improved in 3 weeks. To characterize the skin eruption, we reviewed previous reports on COVID-19 (confirmed by the detection of SARS-CoV-2 infection) from Asian countries. The type of eruption and timing of its appearance in this case seemed rare. Differences in skin manifestations between Western and Asian countries were noted.


Subject(s)
COVID-19 , Erythema Nodosum , Exanthema , Asia , Erythema Nodosum/diagnosis , Erythema Nodosum/drug therapy , Humans , SARS-CoV-2
4.
Case Rep Infect Dis ; 2020: 8814249, 2020.
Article in English | MEDLINE | ID: covidwho-751446

ABSTRACT

Although a variety of existing drugs are being tested for patients with coronavirus disease 2019 (COVID-19), no efficacious treatment has been found so far, particularly for severe cases. We report successful recovery in an elderly patient with severe pneumonia requiring mechanical ventilation and extracorporeal membrane oxygenation (ECMO). Despite administration of multiple antiviral drugs, including lopinavir/ritonavir, chloroquine, and favipiravir, the patient's condition did not improve. However, after administration of another antiviral drug, remdesivir, we were able to terminate invasive interventions, including ECMO, and subsequently obtained negative polymerase chain reaction results. Although further validation is needed, remdesivir might be effective in treating COVID-19.

5.
The Journal of the Japanese Association for Infectious Diseases ; 94(4):568-572, 2020.
Article in Japanese | WHO COVID | ID: covidwho-722941

ABSTRACT

As no specific therapeutic agents have been established yet for coronavirus disease 2019 (COVID-19), the illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), symptomatic therapy is the mainstay of treatment. Although the “Concept of antiviral treatment for COVID-19, First edition” published by the Japanese Association for Infectious Diseases recommends the use of antiviral medication for infected individuals over the age of 50 years, we have documented the case of a 73-year-old woman with COVID-19 pneumonia who improved without antiviral medication. The patient became infected with SARS-CoV-2 on the cruise ship, Diamond Princess, and first tested positive for SARS-CoV-2, by the RT-PCR test, on February 15, 2020. She was admitted to another hospital with fever and pneumonia on February 16, and on February, the pneumonia worsened in severity, she was transferred to our hospital. However, her condition improved spontaneously within a few days, without any antiviral medication. This report is very valuable for documenting the natural history of COVID-19 pneumonia and can be considered as a reference case for formulating strategies for antiviral drug administration for COVID-19 patients in the future.

6.
JPRN; 27/02/2020; TrialID: JPRN-jRCTs031190226
Clinical Trial Register | ICTRP | ID: ictrp-JPRN-jRCTs031190226

ABSTRACT

Condition:

patients infected with COVID-19
Coronavirus

Intervention:

oral administration of favipiravir

Primary outcome:

expected value and 95% CI of ratio of C-reactive protein before versus after the treatment

Criteria:

Inclusion criteria: positive result for COVID-19 detection test
fever above 37.5 degree Celsius, or pneumonia shadow on chest X-ray or CT-scan
hospital admission

Exclusion criteria: pregnancy
lactation

7.
JPRN; 27/02/2020; TrialID: JPRN-jRCTs031190227
Clinical Trial Register | ICTRP | ID: ictrp-JPRN-jRCTs031190227

ABSTRACT

Condition:

patients infected with COVID-19
Coronavirus

Intervention:

oral administration of lopinavir, ritonavir and hydroxychloroquine with or without oseltamivir

Primary outcome:

expected value and 95% CI of ratio of C-reactive protein before versus after the treatment

Criteria:

Inclusion criteria: positive result for COVID-19 detection test
fever above 37.5 degree Celsius, or pneumonia shadow on chest X-ray or CT-scan
hospital admission

Exclusion criteria: past history of hypersensitivity to lopinavir, ritonavir, hydroxychloroquine or oseltamivir
pregnancy

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