COVID-19
Conditions
Keywords
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Coronavirus disease 2019 (COVID-19), Paxlovid, Nirmatrelvir, Immunocompromised
Brief summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19. Patients with COVID-19 who have more difficulty in fighting against infections have a higher chance of severe illness. Such patients may benefit from longer treatment durations compared to the standard treatment regimen. The study is seeking participants who: * Have a confirmed COVID-19 infection * Are Immunocompromised * Experience onset of signs/symptoms attributable to the current COVID-19 infection within 5 days prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. In addition, this study will also evaluate the efficacy and safety of a second treatment course of nirmatrelvir/ritonavir in people who experience that their COVID-19 is flaring up within 14 days of having taken a 5-day treatment course of nirmatrelvir/ritonavir. For this group, the study is seeking participants who: * Have a confirmed COVID-19 infection * Experience a worsening of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir * The worsening of COVID-19 symptoms must occur within 14 days after completion of the initial 5-day course of nirmatrelvir/ritonavir * Are Immunocompromised * Experience onset of signs/symptoms attributable to the current COVID-19 infection within 48 hours prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. All participants will be taking the study medicine for either 5, 10, or 15 days. The study medication will be taken by mouth 2 times a day. Participants will take part in this study for about 24 weeks. The first dose of study medication is taken at the study site and the rest at home. Selected participants will need to visit the study site at least 10 times during the study.
Interventions
DRUGNirmatrelvir
Participants will receive 2 tablets of nirmatrelvir every 12 hours
DRUGRitonavir
Participants will receive 1 capsule of ritonavir every 12 hours
Participants will receive 2 tablets of placebo for nirmatrelvir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied.
Participants will receive 1 capsule of placebo for ritonavir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(applicable for both the main population and population with rebound): * Participants aged 12 years or older and weighing ≥40 kg at screening. * Immunocompromised * ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. Participants for the main population must have: \- Confirmed SARS-CoV-2 infection as determined by RT-PCR or other acceptable test method in any specimen collected within 5 days prior to randomization for the main study population. Participants form the rebound population must have: \- Confirmed SARS-CoV-2 infection as determined by RT-PCR or rapid antigen testing in any specimen collected within 24h prior to randomization and collected within 14 days after the completion of the initial 5-day treatment course of nirmatrelvir/ritonavir for the population with rebound.
Exclusion criteria
* Current need for hospitalization or anticipated need for hospitalization within 24 h after randomization * Known medical history of active liver disease * Known HIV infection with a viral load \>400 copies/mL or taking prohibited medications for human immunodeficiency virus (HIV) * Receiving dialysis or have known age-specific estimated glomerular filtration rate (eGFR) or estimated creatinine clearance (eCrCl) \<30 mL/min/1.73 m2 at screening as measured by a serum creatinine point of care device * Oxygen saturation of \<92% on room air obtained at rest within 24 hours prior to randomization * Current use of any prohibited concomitant medication(s) * Females who are pregnant and \<14 weeks gestation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Nasopharyngeal (NP) Swab Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) < Lower Limit of Quantitation (LLOQ) From Day 15 to Day 44 | From Day 15 to Day 44 | NP swab was collected by healthcare professional (HCP) from participants and were sent to the central laboratory for viral RNA level testing real-time reverse transcriptase-polymerase chain reaction(RT-PCR). Sustained was defined as NP swab SARS-CoV-2 RNA level not \>=2.0 log10 per milliliter (copies/mL) at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA level \<LLOQ (\<2.0 log10 copies/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Sustained NP Swab SARS-CoV-2 RNA < LLOQ for Participants Through Day 44 With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline | Day 1 through Day 44 | An NP swab was collected by HCP from participants and were sent to the central laboratory for viral RNA level testing RT-PCR. Sustained was defined as NP swab SARS-CoV-2 RNA level not \>=2.0 log10 copies/mL at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA level \< LLOQ. The LLOQ is \<2.0 log10 copies/mL. Time (days) to first sustained NP swab SARS-CoV-2 RNA\<LLOQ (event) was calculated as (First Event Date) - (First Dose Date) +1. |
| Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Baseline; Days 5, 10, 15, 21, 28, 35, and 44; Weeks 12 and 24 | A 6-mL blood sample was collected for adult and pediatric participants and was analyzed to measure SARS-CoV-2 RNA \<LLOQ in Plasma by RT-PCR. The LLOQ is \<2.0 log10 copies/mL. |
| Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Baseline; Days 5, 10, 15, 21, 28, 35 and 44 | An NP swab was collected by HCP from adult and pediatric participants and were sent to the central laboratory for viral RNA level testing RT-PCR. The LLOQ is \<2.0 log10 copies/mL. |
| Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Baseline; Days 5, 10, 15, 21, 28, 35 and 44 | An NP swab was collected by HCP from adult and pediatric participants and were sent to the central laboratory for viral RNA level testing RT-PCR. |
| Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Baseline; Days 5, 10, 15, 21, 28, 35 and 44 | A 6-mL blood sample was collected for adult and pediatric participants and was analyzed to measure SARS-CoV-2 RNA by RT-PCR. |
| Number of Participants With Rebound in SARS-CoV-2 RNA Level in NP Swabs at Follow up | Day 16 through Day 44 | Rebound in SARS-CoV-2 RNA level in NP swabs at follow up (ie, any study visit after end of treatment through Day 44) was defined as a half (0.5) log10 copies/mL increase or greater in SARS-CoV-2 RNA level relative to end of treatment SARS-CoV-2 RNA level based on treatment regimen, with a follow-up viral RNA level \>= 2.5 log10 copies/mL. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation | Day 1 of dosing up to Week 24 | An adverse event (AE) was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. SAE was an AE resulting in any of the following outcomes or considered medically significant: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or birth defect. |
| Percentage of Participants With COVID-19-Related Hospitalization >24 Hours (h) or Death Through Day 28 | Day 1 through Day 28 | Hospitalization \>24 h is defined as \>24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. This included specialized acute medical care unit within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution. |
| Time to First NP Swab SARS-Cov-2 RNA <LLOQ for Participants With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline | Day 1 through Day 44 | An NP swab was collected by HCP from participants and were sent to the central laboratory for viral RNA level testing RT-PCR. The LLOQ is \<2.0 log10 copies/mL. Kaplan-Meier method was used for analysis. Time (days) to first NP swab SARS-CoV-2 RNA\<LLOQ (event) was calculated as (First Event Date) - (First Dose Date) +1. |
| Percentage of Participants With COVID-19-Related Hospitalization Through Day 44 and Week 24 | Day 1 through Day 44 and Day 1 through Week 24 | COVID-19 related hospitalization is defined as \>24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. This included specialized acute medical care unit within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution. |
| Percentage of Participants With COVID-19-Related Intensive Care Unit (ICU) Admission Through Day 44 and Week 24 | Day 1 through Day 44 and Day 1 through Week 24 | — |
| Percentage of Participants With Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Through Day 44 and Week 24 | Day 1 through Day 44 and Day 1 through Week 24 | Invasive mechanical ventilation or ECMO were types of oxygen support received in hospital. |
| Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24 | Day 1 through Day 44 and Day 1 through Week 24 | Hospitalization \>24 hours is defined as \>24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. |
| Mean Number of COVID-19-Related Medical Visits Through Day 44 and Through Week 24 | Day 1 through Day 44 and Day 1 through Week 24 | — |
| Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Day 1 through Day 44 | Symptoms alleviation through day44 of each targeted COVID-19 sign/symptom was defined as first time when each targeted symptom scored as moderate/severe at study entry are scored as mild or absent and a targeted symptom scored mild or absent at study entry are scored as absent.COVID-19 targeted signs/symptoms were muscle or body aches,shortness of breath(SOB)or difficulty breathing,chills or shivering, cough,diarrhea,feeling hot or feverish,headache,nausea,stuffy or runny nose,sense of smell,sense of taste,sore throat,low energy or tiredness, vomit. |
| Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Day 1 through Day 44 | Symptoms resolution through day 44 of each targeted COVID-19 sign/symptom was defined as the first time when each targeted symptom scored as mild, moderate or severe at study entry are scored as absent. COVID -19 targeted signs/symptoms were muscle or body aches, SOB or difficulty breathing, chills or shivering, cough, diarrhoea, feeling hot or feverish, headache, nausea, stuffy or runny nose, sense of smell, sense of taste, sore throat, low energy or tiredness, vomit. |
| Percentage of Participants With Any Severe Targeted Signs and Symptoms Attributed to COVID-19 Through Day 44 | Day 1 through Day 44 | COVID-19 targeted signs/symptoms were muscle or body aches, SOB or difficulty breathing, chills or shivering, cough, diarrhea, feeling hot or feverish, headache, nausea, stuffy or runny nose, sense of smell, sense of taste, sore throat, low energy or tiredness, vomit. |
| Percentage of Participants With Death Through Week 24 | Day 1 through Week 24 | Death due to any cause through week 24 was considered. Kaplan-Meier method was used for evaluation. |
Countries
Australia, Brazil, Bulgaria, Canada, Hungary, Mexico, Slovakia, Spain, United States
Participant flow
Recruitment details
In this study there were following population enrolled: main study population (MSP) and rebound population (RP). MSP: Non-hospitalized participants aged greater than or equal to (\>=) 12 years weighing \>= 40 kilogram(kg) who were immunocompromised and diagnosed with symptomatic Coronavirus disease 2019 (COVID-19) were enrolled. RP: Non-hospitalized participants with documented, symptomatic COVID-19 rebound within 14 days after 5-day treatment with nirmatrelvir/ritonavir were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \>=30 to less than (\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\^2) or estimated creatinine clearance (eCrCl) \>=30 to \<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24. | 54 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \>=30 to \<60 mL/min/1.73 m\^2 or eCrCl \>=30 to \<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24. | 52 |
| Nirmatrelvir + Ritonavir 15 Day Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \>=30 to \<60 mL/min/1.73 m\^2 or eCrCl \>=30 to \<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24. | 51 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Follow-up (Through Day 44) | Adverse Event | 1 | 0 | 0 |
| Follow-up (Through Day 44) | Withdrawal by Subject | 3 | 2 | 6 |
| Long-term Follow-up (Through Week 24) | Death | 1 | 0 | 1 |
| Long-term Follow-up (Through Week 24) | Lost to Follow-up | 1 | 0 | 0 |
| Long-term Follow-up (Through Week 24) | Other | 1 | 0 | 0 |
| Long-term Follow-up (Through Week 24) | Withdrawal by Subject | 4 | 5 | 6 |
| Treatment (15 Days) | Adverse Event | 2 | 1 | 3 |
| Treatment (15 Days) | No longer met eligibility criteria | 0 | 1 | 0 |
| Treatment (15 Days) | Other | 0 | 0 | 1 |
| Treatment (15 Days) | Withdrawal by Subject | 2 | 1 | 4 |
Baseline characteristics
| Characteristic | Total | Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Nirmatrelvir + Ritonavir 15 Day |
|---|---|---|---|---|
| Age, Continuous | 55.85 Years STANDARD_DEVIATION 15.08 | 57.09 Years STANDARD_DEVIATION 14.77 | 54.77 Years STANDARD_DEVIATION 16.2 | 55.63 Years STANDARD_DEVIATION 14.44 |
| Age, Customized 12 - 17 years | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Age, Customized < 12 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 18 - 44 years | 31 Participants | 11 Participants | 9 Participants | 11 Participants |
| Age, Customized 45 - 59 years | 55 Participants | 19 Participants | 19 Participants | 17 Participants |
| Age, Customized 60 - 64 years | 21 Participants | 4 Participants | 7 Participants | 10 Participants |
| Age, Customized 65 - 74 years | 33 Participants | 14 Participants | 11 Participants | 8 Participants |
| Age, Customized >= 75 years | 16 Participants | 6 Participants | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 101 Participants | 36 Participants | 33 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 16 Participants | 19 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants | 1 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 141 Participants | 50 Participants | 47 Participants | 44 Participants |
| Sex: Female, Male Female | 84 Participants | 28 Participants | 30 Participants | 26 Participants |
| Sex: Female, Male Male | 73 Participants | 26 Participants | 22 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 54 | 0 / 52 | 1 / 51 |
| other Total, other adverse events | 12 / 54 | 19 / 52 | 19 / 51 |
| serious Total, serious adverse events | 5 / 54 | 1 / 52 | 4 / 51 |
Outcome results
Primary
Percentage of Participants With Sustained Nasopharyngeal (NP) Swab Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) < Lower Limit of Quantitation (LLOQ) From Day 15 to Day 44
NP swab was collected by healthcare professional (HCP) from participants and were sent to the central laboratory for viral RNA level testing real-time reverse transcriptase-polymerase chain reaction(RT-PCR). Sustained was defined as NP swab SARS-CoV-2 RNA level not \>=2.0 log10 per milliliter (copies/mL) at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA level \<LLOQ (\<2.0 log10 copies/mL).
Time frame: From Day 15 to Day 44
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With Sustained Nasopharyngeal (NP) Swab Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) < Lower Limit of Quantitation (LLOQ) From Day 15 to Day 44 | 61.54 Percentage of participants | 0.483 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With Sustained Nasopharyngeal (NP) Swab Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) < Lower Limit of Quantitation (LLOQ) From Day 15 to Day 44 | 70.83 Percentage of participants | 0.58 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With Sustained Nasopharyngeal (NP) Swab Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) < Lower Limit of Quantitation (LLOQ) From Day 15 to Day 44 | 66.00 Percentage of participants | 0.529 |
Secondary
Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44
An NP swab was collected by HCP from adult and pediatric participants and were sent to the central laboratory for viral RNA level testing RT-PCR.
Time frame: Baseline; Days 5, 10, 15, 21, 28, 35 and 44
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here Number of Participants Analyzed were participants evaluable for this outcome measure. All participants reported under Number of Participants Analyzed contributed data to table but may not have evaluable data for every row. Here, number analyzed signifies participants with non-missing data in the analysis set and evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 10 | -4.167 log10 copies/mL | Standard Deviation 2.292 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 28 | -5.938 log10 copies/mL | Standard Deviation 2.138 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 21 | -5.472 log10 copies/mL | Standard Deviation 2.028 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 5 | -3.449 log10 copies/mL | Standard Deviation 1.73 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 44 | -5.916 log10 copies/mL | Standard Deviation 1.865 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 35 | -6.237 log10 copies/mL | Standard Deviation 1.746 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 15 | -4.827 log10 copies/mL | Standard Deviation 2.476 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 21 | -6.328 log10 copies/mL | Standard Deviation 1.472 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 5 | -3.621 log10 copies/mL | Standard Deviation 1.521 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 10 | -4.931 log10 copies/mL | Standard Deviation 1.899 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 15 | -5.773 log10 copies/mL | Standard Deviation 1.473 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 28 | -6.509 log10 copies/mL | Standard Deviation 1.571 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 35 | -6.596 log10 copies/mL | Standard Deviation 1.453 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 44 | -6.597 log10 copies/mL | Standard Deviation 1.445 |
| Nirmatrelvir + Ritonavir 15 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 28 | -6.530 log10 copies/mL | Standard Deviation 1.77 |
| Nirmatrelvir + Ritonavir 15 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 10 | -5.002 log10 copies/mL | Standard Deviation 1.942 |
| Nirmatrelvir + Ritonavir 15 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 44 | -6.707 log10 copies/mL | Standard Deviation 1.922 |
| Nirmatrelvir + Ritonavir 15 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 35 | -6.633 log10 copies/mL | Standard Deviation 1.816 |
| Nirmatrelvir + Ritonavir 15 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 21 | -6.319 log10 copies/mL | Standard Deviation 1.967 |
| Nirmatrelvir + Ritonavir 15 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 15 | -6.009 log10 copies/mL | Standard Deviation 2.093 |
| Nirmatrelvir + Ritonavir 15 Day | Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 5 | -3.746 log10 copies/mL | Standard Deviation 1.687 |
Secondary
Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44
A 6-mL blood sample was collected for adult and pediatric participants and was analyzed to measure SARS-CoV-2 RNA by RT-PCR.
Time frame: Baseline; Days 5, 10, 15, 21, 28, 35 and 44
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants with non-missing data in the analysis set and evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 21 | -1.700 log10 copies/mL | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 35 | -1.700 log10 copies/mL | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 10 | -1.487 log10 copies/mL | Standard Deviation 0.601 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 44 | -1.700 log10 copies/mL | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 5 | -1.457 log10 copies/mL | Standard Deviation 0.643 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 15 | -1.700 log10 copies/mL | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 28 | -1.700 log10 copies/mL | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 5 | -1.360 log10 copies/mL | Standard Deviation 0.717 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 28 | -1.700 log10 copies/mL | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 35 | -1.700 log10 copies/mL | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 15 | -1.700 log10 copies/mL | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 21 | -1.700 log10 copies/mL | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 44 | -1.700 log10 copies/mL | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 10 | -1.700 log10 copies/mL | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 15 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 44 | -1.880 log10 copies/mL | Standard Deviation 0.38 |
| Nirmatrelvir + Ritonavir 15 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 5 | -1.528 log10 copies/mL | Standard Deviation 0.626 |
| Nirmatrelvir + Ritonavir 15 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 10 | -1.880 log10 copies/mL | Standard Deviation 0.38 |
| Nirmatrelvir + Ritonavir 15 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 21 | -1.880 log10 copies/mL | Standard Deviation 0.38 |
| Nirmatrelvir + Ritonavir 15 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 28 | -1.910 log10 copies/mL | Standard Deviation 0.405 |
| Nirmatrelvir + Ritonavir 15 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 35 | -1.894 log10 copies/mL | Standard Deviation 0.392 |
| Nirmatrelvir + Ritonavir 15 Day | Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | Change at Day 15 | -1.880 log10 copies/mL | Standard Deviation 0.38 |
Secondary
Mean Number of COVID-19-Related Medical Visits Through Day 44 and Through Week 24
Time frame: Day 1 through Day 44 and Day 1 through Week 24
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Mean Number of COVID-19-Related Medical Visits Through Day 44 and Through Week 24 | Through Day 44 | 0.115 Medical visits | Standard Deviation 0.615 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Mean Number of COVID-19-Related Medical Visits Through Day 44 and Through Week 24 | Through Week 24 | 0.115 Medical visits | Standard Deviation 0.615 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Mean Number of COVID-19-Related Medical Visits Through Day 44 and Through Week 24 | Through Day 44 | 0.000 Medical visits | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Mean Number of COVID-19-Related Medical Visits Through Day 44 and Through Week 24 | Through Week 24 | 0.000 Medical visits | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 15 Day | Mean Number of COVID-19-Related Medical Visits Through Day 44 and Through Week 24 | Through Day 44 | 0.000 Medical visits | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 15 Day | Mean Number of COVID-19-Related Medical Visits Through Day 44 and Through Week 24 | Through Week 24 | 0.020 Medical visits | Standard Deviation 0.141 |
Secondary
Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24
Hospitalization \>24 hours is defined as \>24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19.
Time frame: Day 1 through Day 44 and Day 1 through Week 24
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24 | ICU Stay: Up to Day 44 | 0.442 Days | Standard Deviation 3.19 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24 | ICU Stay: Up to Week 24 | 0.442 Days | Standard Deviation 3.19 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24 | Hospital Stay: Up to Week 24 | 0.635 Days | Standard Deviation 3.453 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24 | Hospital Stay: Up to Day 44 | 0.635 Days | Standard Deviation 3.453 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24 | Hospital Stay: Up to Day 44 | 0.000 Days | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24 | Hospital Stay: Up to Week 24 | 0.000 Days | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24 | ICU Stay: Up to Week 24 | 0.000 Days | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24 | ICU Stay: Up to Day 44 | 0.000 Days | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 15 Day | Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24 | ICU Stay: Up to Week 24 | 0.000 Days | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 15 Day | Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24 | Hospital Stay: Up to Day 44 | 0.000 Days | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 15 Day | Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24 | Hospital Stay: Up to Week 24 | 0.000 Days | Standard Deviation 0 |
| Nirmatrelvir + Ritonavir 15 Day | Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24 | ICU Stay: Up to Day 44 | 0.000 Days | Standard Deviation 0 |
Secondary
Number of Participants With Rebound in SARS-CoV-2 RNA Level in NP Swabs at Follow up
Rebound in SARS-CoV-2 RNA level in NP swabs at follow up (ie, any study visit after end of treatment through Day 44) was defined as a half (0.5) log10 copies/mL increase or greater in SARS-CoV-2 RNA level relative to end of treatment SARS-CoV-2 RNA level based on treatment regimen, with a follow-up viral RNA level \>= 2.5 log10 copies/mL.
Time frame: Day 16 through Day 44
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Number of Participants With Rebound in SARS-CoV-2 RNA Level in NP Swabs at Follow up | 9 Participants |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Number of Participants With Rebound in SARS-CoV-2 RNA Level in NP Swabs at Follow up | 1 Participants |
| Nirmatrelvir + Ritonavir 15 Day | Number of Participants With Rebound in SARS-CoV-2 RNA Level in NP Swabs at Follow up | 1 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation
An adverse event (AE) was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. SAE was an AE resulting in any of the following outcomes or considered medically significant: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or birth defect.
Time frame: Day 1 of dosing up to Week 24
Population: Safety population included all randomized participants who received at least 1 dose of the study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation | SAEs | 5 Participants |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation | TEAEs | 28 Participants |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation | AEs Leading to Study Treatment Discontinuation | 1 Participants |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation | SAEs | 1 Participants |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation | TEAEs | 34 Participants |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation | AEs Leading to Study Treatment Discontinuation | 1 Participants |
| Nirmatrelvir + Ritonavir 15 Day | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation | TEAEs | 31 Participants |
| Nirmatrelvir + Ritonavir 15 Day | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation | AEs Leading to Study Treatment Discontinuation | 4 Participants |
| Nirmatrelvir + Ritonavir 15 Day | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation | SAEs | 4 Participants |
Secondary
Percentage of Participants With Any Severe Targeted Signs and Symptoms Attributed to COVID-19 Through Day 44
COVID-19 targeted signs/symptoms were muscle or body aches, SOB or difficulty breathing, chills or shivering, cough, diarrhea, feeling hot or feverish, headache, nausea, stuffy or runny nose, sense of smell, sense of taste, sore throat, low energy or tiredness, vomit.
Time frame: Day 1 through Day 44
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With Any Severe Targeted Signs and Symptoms Attributed to COVID-19 Through Day 44 | 28.85 Percentage of participants |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With Any Severe Targeted Signs and Symptoms Attributed to COVID-19 Through Day 44 | 31.25 Percentage of participants |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With Any Severe Targeted Signs and Symptoms Attributed to COVID-19 Through Day 44 | 38.00 Percentage of participants |
Secondary
Percentage of Participants With COVID-19-Related Hospitalization >24 Hours (h) or Death Through Day 28
Hospitalization \>24 h is defined as \>24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. This included specialized acute medical care unit within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution.
Time frame: Day 1 through Day 28
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With COVID-19-Related Hospitalization >24 Hours (h) or Death Through Day 28 | Hospitalization | 3.846 Percentage of participants |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With COVID-19-Related Hospitalization >24 Hours (h) or Death Through Day 28 | Death | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With COVID-19-Related Hospitalization >24 Hours (h) or Death Through Day 28 | Hospitalization | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With COVID-19-Related Hospitalization >24 Hours (h) or Death Through Day 28 | Death | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With COVID-19-Related Hospitalization >24 Hours (h) or Death Through Day 28 | Hospitalization | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With COVID-19-Related Hospitalization >24 Hours (h) or Death Through Day 28 | Death | 0 Percentage of participants |
Secondary
Percentage of Participants With COVID-19-Related Hospitalization Through Day 44 and Week 24
COVID-19 related hospitalization is defined as \>24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. This included specialized acute medical care unit within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution.
Time frame: Day 1 through Day 44 and Day 1 through Week 24
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With COVID-19-Related Hospitalization Through Day 44 and Week 24 | Through Day 44 | 3.846 Percentage of participants |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With COVID-19-Related Hospitalization Through Day 44 and Week 24 | Through Week 24 | 3.846 Percentage of participants |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With COVID-19-Related Hospitalization Through Day 44 and Week 24 | Through Day 44 | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With COVID-19-Related Hospitalization Through Day 44 and Week 24 | Through Week 24 | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With COVID-19-Related Hospitalization Through Day 44 and Week 24 | Through Day 44 | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With COVID-19-Related Hospitalization Through Day 44 and Week 24 | Through Week 24 | 0 Percentage of participants |
Secondary
Percentage of Participants With COVID-19-Related Intensive Care Unit (ICU) Admission Through Day 44 and Week 24
Time frame: Day 1 through Day 44 and Day 1 through Week 24
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With COVID-19-Related Intensive Care Unit (ICU) Admission Through Day 44 and Week 24 | Through Day 44 | 1.923 Percentage of participants |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With COVID-19-Related Intensive Care Unit (ICU) Admission Through Day 44 and Week 24 | Through Week 24 | 1.923 Percentage of participants |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With COVID-19-Related Intensive Care Unit (ICU) Admission Through Day 44 and Week 24 | Through Day 44 | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With COVID-19-Related Intensive Care Unit (ICU) Admission Through Day 44 and Week 24 | Through Week 24 | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With COVID-19-Related Intensive Care Unit (ICU) Admission Through Day 44 and Week 24 | Through Day 44 | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With COVID-19-Related Intensive Care Unit (ICU) Admission Through Day 44 and Week 24 | Through Week 24 | 0 Percentage of participants |
Secondary
Percentage of Participants With Death Through Week 24
Death due to any cause through week 24 was considered. Kaplan-Meier method was used for evaluation.
Time frame: Day 1 through Week 24
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With Death Through Week 24 | 1.923 Percentage of participants |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With Death Through Week 24 | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With Death Through Week 24 | 0 Percentage of participants |
Secondary
Percentage of Participants With Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Through Day 44 and Week 24
Invasive mechanical ventilation or ECMO were types of oxygen support received in hospital.
Time frame: Day 1 through Day 44 and Day 1 through Week 24
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Through Day 44 and Week 24 | Through Day 44 | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Through Day 44 and Week 24 | Through Week 24 | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Through Day 44 and Week 24 | Through Day 44 | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Through Day 44 and Week 24 | Through Week 24 | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Through Day 44 and Week 24 | Through Day 44 | 0 Percentage of participants |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Through Day 44 and Week 24 | Through Week 24 | 0 Percentage of participants |
Secondary
Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44
An NP swab was collected by HCP from adult and pediatric participants and were sent to the central laboratory for viral RNA level testing RT-PCR. The LLOQ is \<2.0 log10 copies/mL.
Time frame: Baseline; Days 5, 10, 15, 21, 28, 35 and 44
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Baseline | 5.77 Percentage of participants | 0.292 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 5 | 38.46 Percentage of participants | 0.832 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 10 | 51.92 Percentage of participants | 0.872 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 15 | 69.23 Percentage of participants | 0.903 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 21 | 71.15 Percentage of participants | 0.905 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 28 | 80.77 Percentage of participants | 0.916 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 35 | 80.77 Percentage of participants | 0.916 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 44 | 78.85 Percentage of participants | 0.914 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 10 | 64.58 Percentage of participants | 0.888 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 35 | 91.67 Percentage of participants | 0.92 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 15 | 77.08 Percentage of participants | 0.905 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 21 | 91.67 Percentage of participants | 0.92 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 28 | 93.75 Percentage of participants | 0.921 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Baseline | 8.33 Percentage of participants | 0.398 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 5 | 29.17 Percentage of participants | 0.768 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 44 | 91.67 Percentage of participants | 0.92 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 10 | 58.00 Percentage of participants | 0.881 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 5 | 38.00 Percentage of participants | 0.824 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Baseline | 4.00 Percentage of participants | 0.158 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 15 | 72.00 Percentage of participants | 0.903 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 35 | 84.00 Percentage of participants | 0.916 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 28 | 76.00 Percentage of participants | 0.907 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 21 | 78.00 Percentage of participants | 0.91 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44 | Day 44 | 88.00 Percentage of participants | 0.92 |
Secondary
Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24
A 6-mL blood sample was collected for adult and pediatric participants and was analyzed to measure SARS-CoV-2 RNA \<LLOQ in Plasma by RT-PCR. The LLOQ is \<2.0 log10 copies/mL.
Time frame: Baseline; Days 5, 10, 15, 21, 28, 35, and 44; Weeks 12 and 24
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Baseline | 98.08 Percentage of participants | 0.93 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 5 | 90.38 Percentage of participants | 0.925 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 10 | 92.31 Percentage of participants | 0.926 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 15 | 88.46 Percentage of participants | 0.923 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 21 | 86.54 Percentage of participants | 0.921 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 28 | 84.62 Percentage of participants | 0.92 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 35 | 82.69 Percentage of participants | 0.918 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 44 | 86.54 Percentage of participants | 0.921 |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Week 12 | 73.08 Percentage of participants | — |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Week 24 | 69.23 Percentage of participants | — |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Week 12 | 87.50 Percentage of participants | — |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Baseline | 97.92 Percentage of participants | 0.925 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 28 | 95.83 Percentage of participants | 0.923 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 21 | 93.75 Percentage of participants | 0.921 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 5 | 93.75 Percentage of participants | 0.921 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Week 24 | 85.42 Percentage of participants | — |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 44 | 91.67 Percentage of participants | 0.92 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 10 | 95.83 Percentage of participants | 0.923 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 35 | 93.75 Percentage of participants | 0.921 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 15 | 91.67 Percentage of participants | 0.92 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 44 | 88.00 Percentage of participants | 0.92 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 15 | 88.00 Percentage of participants | 0.92 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 21 | 88.00 Percentage of participants | 0.92 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 28 | 78.00 Percentage of participants | 0.91 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Week 12 | 78.00 Percentage of participants | — |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 35 | 84.00 Percentage of participants | 0.916 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Baseline | 92.00 Percentage of participants | 0.923 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Week 24 | 84.00 Percentage of participants | — |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 5 | 92.00 Percentage of participants | 0.923 |
| Nirmatrelvir + Ritonavir 15 Day | Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24 | Day 10 | 92.00 Percentage of participants | 0.923 |
Secondary
Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44
Symptoms alleviation through day44 of each targeted COVID-19 sign/symptom was defined as first time when each targeted symptom scored as moderate/severe at study entry are scored as mild or absent and a targeted symptom scored mild or absent at study entry are scored as absent.COVID-19 targeted signs/symptoms were muscle or body aches,shortness of breath(SOB)or difficulty breathing,chills or shivering, cough,diarrhea,feeling hot or feverish,headache,nausea,stuffy or runny nose,sense of smell,sense of taste,sore throat,low energy or tiredness, vomit.
Time frame: Day 1 through Day 44
Population: Evaluable analysis set analyzed. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure. All participants reported under Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, Number Analyzed signifies number of participants with non-missing data and with baseline severity of mild, moderate and severe of targeted signs/symptoms.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Sense of taste | 10.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Feeling hot or feverish | 5.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Chills or shivering | 5.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Sense of smell | 9.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Headache | 9.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | SOB or difficulty breathing | 6.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Stuffy or runny nose | 9.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Nausea | 9.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Sore throat | 6.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Cough | 6.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Vomit | 6.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Muscle or body aches | 6.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Diarrhea | 9.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Low energy or tiredness | 9.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Sense of taste | 9.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Muscle or body aches | 9.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | SOB or difficulty breathing | 9.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Chills or shivering | 4.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Cough | 9.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Diarrhea | 5.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Feeling hot or feverish | 4.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Headache | 5.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Nausea | 4.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Stuffy or runny nose | 9.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Sense of smell | 9.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Sore throat | 5.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Low energy or tiredness | 9.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Vomit | 4.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Low energy or tiredness | 9.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Sense of smell | 9.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Diarrhea | 9.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Cough | 10.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Sense of taste | 9.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Chills or shivering | 5.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Muscle or body aches | 9.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Sore throat | 5.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | SOB or difficulty breathing | 6.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Nausea | 6.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Headache | 5.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Vomit | 4.500 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Stuffy or runny nose | 9.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44 | Feeling hot or feverish | 5.000 Days |
Secondary
Time to First NP Swab SARS-Cov-2 RNA <LLOQ for Participants With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline
An NP swab was collected by HCP from participants and were sent to the central laboratory for viral RNA level testing RT-PCR. The LLOQ is \<2.0 log10 copies/mL. Kaplan-Meier method was used for analysis. Time (days) to first NP swab SARS-CoV-2 RNA\<LLOQ (event) was calculated as (First Event Date) - (First Dose Date) +1.
Time frame: Day 1 through Day 44
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure with non-missing data in the analysis set.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First NP Swab SARS-Cov-2 RNA <LLOQ for Participants With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline | 9.500 Days | 95% Confidence Interval 6 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First NP Swab SARS-Cov-2 RNA <LLOQ for Participants With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline | 11.000 Days | 95% Confidence Interval 10 |
| Nirmatrelvir + Ritonavir 15 Day | Time to First NP Swab SARS-Cov-2 RNA <LLOQ for Participants With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline | 9.000 Days | 95% Confidence Interval 6 |
Secondary
Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44
Symptoms resolution through day 44 of each targeted COVID-19 sign/symptom was defined as the first time when each targeted symptom scored as mild, moderate or severe at study entry are scored as absent. COVID -19 targeted signs/symptoms were muscle or body aches, SOB or difficulty breathing, chills or shivering, cough, diarrhoea, feeling hot or feverish, headache, nausea, stuffy or runny nose, sense of smell, sense of taste, sore throat, low energy or tiredness, vomit.
Time frame: Day 1 through Day 44
Population: Evaluable analysis set analyzed. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure. All participants reported under Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, Number Analyzed signifies number of participants with non-missing data and with baseline severity of mild, moderate and severe of targeted signs and symptoms.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Sense of taste | 10.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Feeling hot or feverish | 9.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Chills or shivering | 6.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Sense of smell | 10.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Headache | 13.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | SOB or difficulty breathing | 9.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Stuffy or runny nose | 14.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Nausea | 9.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Sore throat | 9.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Cough | 13.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Vomit | 6.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Muscle or body aches | 14.500 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Diarrhea | 9.000 Days |
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Low energy or tiredness | 27.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Sense of taste | 10.500 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Muscle or body aches | 11.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | SOB or difficulty breathing | 9.500 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Chills or shivering | 4.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Cough | 12.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Diarrhea | 9.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Feeling hot or feverish | 7.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Headache | 10.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Nausea | 4.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Stuffy or runny nose | 13.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Sense of smell | 9.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Sore throat | 9.500 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Low energy or tiredness | 20.000 Days |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Vomit | 4.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Low energy or tiredness | 22.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Sense of smell | 9.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Diarrhea | 16.500 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Cough | 19.500 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Sense of taste | 10.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Chills or shivering | 5.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Muscle or body aches | 10.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Sore throat | 9.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | SOB or difficulty breathing | 12.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Nausea | 9.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Headache | 9.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Vomit | 4.500 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Stuffy or runny nose | 13.000 Days |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44 | Feeling hot or feverish | 5.000 Days |
Secondary
Time to First Sustained NP Swab SARS-CoV-2 RNA < LLOQ for Participants Through Day 44 With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline
An NP swab was collected by HCP from participants and were sent to the central laboratory for viral RNA level testing RT-PCR. Sustained was defined as NP swab SARS-CoV-2 RNA level not \>=2.0 log10 copies/mL at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA level \< LLOQ. The LLOQ is \<2.0 log10 copies/mL. Time (days) to first sustained NP swab SARS-CoV-2 RNA\<LLOQ (event) was calculated as (First Event Date) - (First Dose Date) +1.
Time frame: Day 1 through Day 44
Population: Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure with non-missing data in the analysis set.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | Time to First Sustained NP Swab SARS-CoV-2 RNA < LLOQ for Participants Through Day 44 With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline | 15.000 Days | 95% Confidence Interval 9 |
| Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | Time to First Sustained NP Swab SARS-CoV-2 RNA < LLOQ for Participants Through Day 44 With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline | 11.000 Days | 95% Confidence Interval 10 |
| Nirmatrelvir + Ritonavir 15 Day | Time to First Sustained NP Swab SARS-CoV-2 RNA < LLOQ for Participants Through Day 44 With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline | 10.000 Days | 95% Confidence Interval 9 |