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1.
JPRN; 13/10/2021; TrialID: JPRN-jRCTs051210107
Clinical Trial Register | ICTRP | ID: ictrp-JPRN-jRCTs051210107

ABSTRACT

Condition:

COVID-19 infection
COVID-19 infection;C000657245

Intervention:

The intervention is a gargle or a water gargle.

Primary outcome:

The amount of virus excreted from the oral cavity by gargling is measured, and the virus removal effect from the oral cavity by gargling is confirmed. Also, evaluate the difference from water gargling.

Criteria:

Inclusion criteria: (1) Subjects whose age at the time of obtaining consent is more than 20 years
(2) Sex; female
(3) quarantine at the hotel
(4) Meets all of 1)-3) below
1) Subjects whose Asymptomatic/mild case (without respiratory sympton nor dyspnea) has at least one RT-PCR test positive for SARS-CoV-2 from pharyng eal swab, nasopharyng eal swab or saliva.
2) Subjects who can gargle
3) Subjects who are on the first day of admission to the accommodation treatment facility and plan to perform accommodation treatment for 6 days or more
(5) Subjects who have obtained written consent voluntarily to participate in the trial

Exclusion criteria: Garg ling with sodium lauryl diethylendiaminoglycine before entry

2.
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
3.
JPRN; 24/11/2020; TrialID: JPRN-jRCT1051200078
Clinical Trial Register | ICTRP | ID: ictrp-JPRN-jRCT1051200078

ABSTRACT

Condition:

COVID-19 infection
COVID-19 infection;C000657245

Intervention:

The intervention is a gargle or a water gargle with a 15-fold diluted gargle solution containing 7% gargle of povidone iodine. Povidone-iodine early gargle group was instructed to perform povidone-iodine gargle from the 2nd day to 6th day of treatment, and in povidone-iodine delayed gargle group, water gargle from 2nd to 4th day of medical treatment, and 5th and 6th day. Povidone Iodine is instructed to gargle. The gargle should be performed after waking up and before sampling, before lunch, before dinner, and before going to bed.

Primary outcome:

Among the subjects in which the virus was detected by RT-PCR of saliva samples on the 2nd day of accommodation treatment, the negative rate of SARS-CoV-2 virus by RT-PCR of saliva on the 5th day of accommodation treatment.

Criteria:

Inclusion criteria: (1)Subjects who are 16 years old or older on the date of consent acquisition and who have obtained the consent of the substitute if they are 16 years old or older and less than 20 years old
(2)Sex; male or female
(3)quarantine at the hotel
(4)Meets all of 1)-3) below
1) Subjects whose Asymptomatic/mild case has at least one RT-PCR test positive for SARS-CoV-2 from pharyngeal swab, nasopharyngeal swab or saliva.
2) Subjects who can gargle
3) Subjects who will be quarantined for 6days or more
(5)Subjects who have obtained written consent voluntarily to participate in the trial

Exclusion criteria: (1) Subjects who are on thyroid hormone preparation
(2) Subjects who have Iodine allergy
(3) Pregnant
(4) Lactating female
(5) Gargling with Povidone iodine before entry

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