A Study to Learn About PAXLOVID (a Commercial Medicine) In People With COVID-19

Adverse drug reaction (ADR) was a treatment-related adverse event and any untoward medical occurrence attributed to Paxlovid PACK in a participant who received Paxlovid PACK. Serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Paxlovid PACK was assessed by the physician.

Time frame: From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45 days.

Population: The safety analysis set (2829 participants) comprised of participants who satisfied the inclusion criteria. Participants with no informed consent for publication of study results, no information on administration, and no information on adverse events - no re-visits were excluded.

The percent probability is the percent of the participants who had COVID-19 related hospitalization or death from any cause.

Time frame: 3, 5, 7, 14, 21 and 28 days after the start of administration with Paxlovid PACK.

Population: For the efficacy analysis set #3 (1905 participants), participants with no risk factors of progressing to severe illness (60 participants) were excluded from the efficacy analysis set #2.

The percent probability is the percent of the participants who had COVID-19 related hospitalization or death from any cause. Sensitivity analysis was conducted by changing the event definition of hospitalization for treatment of infection caused by SARS-CoV-2 as follows: there were concomitant medications for infection caused by SARS-CoV-2 or concomitant non-drug therapies due to infection caused by SARS-CoV-2 on or after the date of administration.

Time frame: 3, 5, 7, 14, 21 and 28 days after the start of administration with Paxlovid PACK.

Population: For the efficacy analysis set #3 (1905 participants), participants with no risk factors of progressing to severe illness (60 participants) were excluded from the efficacy analysis set #2.

Whether the severity of infection caused by SARS-CoV-2 had worsened was evaluated. However, when the severity was severe at the start of Paxlovid PACK and did not worsen during the observation period, it was considered as severe at the start of treatment.

Time frame: From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45 days.

Population: For the efficacy analysis set #1 (2828 participants), participant with disease not subject to the study (1 participant) was excluded from the safety analysis set.

Whether the severity of infection caused by SARS-CoV-2 had worsened was evaluated. However, when the severity was severe at the start of Paxlovid PACK and did not worsen during the observation period, it was considered as severe at the start of treatment.

Time frame: From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 35 days.

Population: For the efficacy analysis set #2 (1965 participants), participants other than outpatient at the start of treatment (863 participants) were excluded from the efficacy analysis set #1.

Whether the severity of infection caused by SARS-CoV-2 had worsened was evaluated. However, when the severity was severe at the start of Paxlovid PACK and did not worsen during the observation period, it was considered as severe at the start of treatment.

Time frame: From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 35 days.

Population: For the efficacy analysis set #3 (1905 participants), participants with no risk factors of progressing to severe illness (60 participants) were excluded from the efficacy analysis set #2.