COVID-19
Conditions
Interventions
None listed
Sponsors
Shionogi & Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are eligible. 1) Patients who have given informed consent/assent in writing of their own free will to participate in this study (including their parental consent in case of patients are under 18 years of age at the time of consent) 2) Male and Female aged 12 years or older at the time of informed consent 3) Patients who are diagnosed SARS-CoV-2 positive by Nucleic Acid Amplification test (PCR, LAMP, NEAR), Qualitative Antigen Test or Quantitative Antigen Test on the enrollment date by their principal (or sub-) investigator 4) Patents who are at high risk of severe disease or expected progression of symptoms at the date of enrollment, or patients without risk factors for severe disease with severe symptoms related to COVID-19 such as fever, sore throat and cough 5) Patients who are able to prepare a smartphone or tablet device and an environment to connect to the application in order to answer the questionnaire
Exclusion criteria
Exclusion criteria: Patients who meet at least one of the following criteria are excluded. 1) Patients who are judged by their principal (or sub-) investigator from each site to ineligible to participate in this study 2) Hospitalized patients or patients who are treated COVID-19 in hospital 3) Patients who received anti-SARS-Cov-2 drugs within 30 days prior to enrollment 4) Patients who receiving injectable anti-SARS-CoV-2 drugs, or drugs with reported effects on SARS-CoV-2 such as favipiravir and ivermectin at the date of enrollment (however, molnupiravir, nirmatrelvir/ ritonavir and ensitrelvir can be administered) 5) Patients who have previously participated in this study 6) Patients who are currently participating in clinical trials or interventional prospective studies, not limited to COVID-19 related study 7) Patients who have not received 30 days of the last dose or 5 times the half-life period of the investigational study drug or unapproved drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Subject background -Drug adherence -Time to resolution of each COVID-19 symptom -Time to resolution of COVID-19 symptoms -Time to fever resolution -Frequency of Post COVID-19 Condition -Change from baseline in Quality of Life(12-Item Short Form Health Survey) -Change from baseline in work productivity score(Work Productivity and Activity Impairment Questionnaire) -Frequency of severe COVID-19 -Frequency of return visit for COVID-19 -Frequency of secondary infection in family members -Adverse events | — |
Countries
Japan
Contacts
Public ContactNaomi Uemura
Shionogi & Co., Ltd. Medical Affairs
Outcome results
None listed