| 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 \ | 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. | Posted | | Number | | Percentage of participants | | From Day 15 to Day 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00061.54± 0.483(0.483 to 0.748)
- OG00170.83± 0.580(0.580 to 0.837)
- OG00266.00± 0.529(0.529 to 0.791)
|
|
| |
| 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\ | 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. | Posted | | Median | 95% Confidence Interval | Days | | Day 1 through Day 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day |
|
| 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\ | 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. | Posted | | Median | 95% Confidence Interval | Days | | Day 1 through Day 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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 \ | 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. | Posted | | Number | | Percentage of participants | | Baseline; Days 5, 10, 15, 21, 28, 35, and 44; Weeks 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | | Percentage of participants | | Baseline; Days 5, 10, 15, 21, 28, 35 and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | log10 copies/mL | | Baseline; Days 5, 10, 15, 21, 28, 35 and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | log10 copies/mL | | Baseline; Days 5, 10, 15, 21, 28, 35 and 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Count of Participants | | Participants | | Day 16 through Day 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | |
|
| 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. | Safety population included all randomized participants who received at least 1 dose of the study intervention. | Posted | | Count of Participants | | Participants | | Day 1 of dosing up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | 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. | Posted | | Number | | Percentage of participants | | Day 1 through Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day |
|
| 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. | 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. | Posted | | Number | | Percentage of participants | | Day 1 through Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | | Percentage of participants | | Day 1 through Day 44 and Day 1 through Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day |
|
| Secondary | Percentage of Participants With COVID-19-Related Intensive Care Unit (ICU) Admission Through Day 44 and Week 24 | | 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. | Posted | | Number | | Percentage of participants | | Day 1 through Day 44 and Day 1 through Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | | Percentage of participants | | Day 1 through Day 44 and Day 1 through Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Days | | Day 1 through Day 44 and Day 1 through Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Mean Number of COVID-19-Related Medical Visits Through Day 44 and Through Week 24 | | 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. | Posted | | Mean | Standard Deviation | Medical visits | | Day 1 through Day 44 and Day 1 through Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Median | 95% Confidence Interval | Days | | Day 1 through Day 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | 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. | Posted | | Median | 95% Confidence Interval | Days | | Day 1 through Day 44 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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. | Posted | | Number | | Percentage of participants | | Day 1 through Day 44 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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