Trial Outcomes & Findings for Paxlovid for Treatment of Long Covid (NCT NCT05576662)
NCT ID: NCT05576662
Last Updated: 2025-09-04
Results Overview
This measure was to evaluate whether there is a difference between treatment with Paxlovid versus placebo on any of the 6 core symptoms of PASC at week 10 (adjusting for patients' baseline levels). Each symptom (fatigue, brain fog, dyspnea, body aches, gastrointestinal symptoms, cardiovascular symptoms) was assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
168 participants
Primary outcome timeframe
Week 10
Results posted on
2025-09-04
Participant Flow
168 participants were consented and screened. 155 participants were randomized to a study arm.
Participant milestones
| Measure |
Nirmatrelvir Plus Ritonavir
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
53
|
|
Overall Study
COMPLETED
|
98
|
49
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Nirmatrelvir Plus Ritonavir
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Overall Study
Withdrawn by site within 15-day treatment period
|
0
|
1
|
|
Overall Study
Requested to withdraw within 15-day treatment period
|
0
|
1
|
|
Overall Study
Lost to follow-up within 15-day treatment period
|
2
|
0
|
|
Overall Study
Requested to withdraw after 15-day treatment period
|
2
|
2
|
Baseline Characteristics
Paxlovid for Treatment of Long Covid
Baseline characteristics by cohort
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.5 years
n=5 Participants
|
41 years
n=7 Participants
|
43 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
102 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Index COVID-19 infection date
Before May 2021
|
39 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Index COVID-19 infection date
May to December 2021
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Index COVID-19 infection date
After December 2021
|
43 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Hospitalized for index COVID-19 infection
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Time from index infection to randomization
|
17.6 months
STANDARD_DEVIATION 9.1 • n=5 Participants
|
17.3 months
STANDARD_DEVIATION 9.1 • n=7 Participants
|
17.5 months
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Total COVID-19 infections
|
1.45 infections
STANDARD_DEVIATION 0.75 • n=5 Participants
|
1.34 infections
STANDARD_DEVIATION 0.55 • n=7 Participants
|
1.41 infections
STANDARD_DEVIATION 0.69 • n=5 Participants
|
|
Prior use of SARS-CoV-2 acute medication
Prior use of medication other than Paxlovid
|
27 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Prior use of SARS-CoV-2 acute medication
Prior use of Paxlovid
|
18 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Prior use of SARS-CoV-2 acute medication
No prior use
|
75 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Vaccination status at randomization
Initial series completed
|
101 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Vaccination status at randomization
Initial series not completed
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27 kg/m^2
STANDARD_DEVIATION 6.19 • n=5 Participants
|
28 kg/m^2
STANDARD_DEVIATION 6.66 • n=7 Participants
|
27.55 kg/m^2
STANDARD_DEVIATION 6.36 • n=5 Participants
|
|
BMI group
Underweight (<18.5)
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
BMI group
Normal (18.5-24.9)
|
39 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
BMI group
Overweight (25.0-29.9)
|
33 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
BMI group
Obesity (≥30.0)
|
26 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Comorbidities
Depression
|
24 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Comorbidities
Allergies
|
1 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Comorbidities
Asthma
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Comorbidities
Anxiety
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Comorbidities
Gastroesophageal reflux disease (GERD)
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Moderate to severe post-COVID-19 symptoms
2-3 symptoms
|
47 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Moderate to severe post-COVID-19 symptoms
>3 symptoms
|
55 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Moderate to severe symptom at baseline
Fatigue
|
97 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Moderate to severe symptom at baseline
Brain fog
|
83 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Moderate to severe symptom at baseline
Body aches
|
59 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Moderate to severe symptom at baseline
Cardiovascular
|
50 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Moderate to severe symptom at baseline
Shortness of breath
|
47 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Moderate to severe symptom at baseline
Gastrointestinal
|
42 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 10Population: If participants did not have week 10 data, week 9 data were used when available; otherwise missing data were imputed for statistical analysis.
This measure was to evaluate whether there is a difference between treatment with Paxlovid versus placebo on any of the 6 core symptoms of PASC at week 10 (adjusting for patients' baseline levels). Each symptom (fatigue, brain fog, dyspnea, body aches, gastrointestinal symptoms, cardiovascular symptoms) was assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Fatigue - no symptoms
|
3 Participants
|
4 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Fatigue - mild symptoms
|
22 Participants
|
17 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Fatigue - moderate symptoms
|
43 Participants
|
17 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Fatigue - severe symptoms
|
31 Participants
|
11 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Brain fog - no symptoms
|
11 Participants
|
8 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Brain fog - mild symptoms
|
34 Participants
|
24 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Brain fog - moderate symptoms
|
35 Participants
|
12 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Brain fog - severe symptoms
|
19 Participants
|
5 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Dyspnea - no symptoms
|
42 Participants
|
13 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Dyspnea - mild symptoms
|
31 Participants
|
21 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Dyspnea - moderate symptoms
|
22 Participants
|
13 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Dyspnea - severe symptoms
|
4 Participants
|
2 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Body aches - no symptoms
|
31 Participants
|
15 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Body aches - mild symptoms
|
32 Participants
|
17 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Body aches - moderate symptoms
|
21 Participants
|
14 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Body aches - severe symptoms
|
15 Participants
|
3 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Gastrointestinal symptoms - no symptoms
|
38 Participants
|
13 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Gastrointestinal symptoms - mild symptoms
|
39 Participants
|
17 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Gastrointestinal symptoms - moderate symptoms
|
17 Participants
|
16 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Gastrointestinal symptoms - severe symptoms
|
5 Participants
|
3 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Cardiovascular symptoms - no symptoms
|
37 Participants
|
17 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Cardiovascular symptoms - mild symptoms
|
35 Participants
|
11 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Cardiovascular symptoms - moderate symptoms
|
20 Participants
|
13 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Cardiovascular symptoms - severe symptoms
|
7 Participants
|
8 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score
Missing Core Symptoms Severity data at week 10
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 15Population: Participants with symptoms data at day 15
This measure was to evaluate whether there is a difference between treatment with Paxlovid versus placebo on any of the 6 core symptoms of PASC at week 10 (adjusting for patients' baseline levels). Each symptom (fatigue, brain fog, dyspnea, body aches, gastrointestinal symptoms, cardiovascular symptoms) was assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=99 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=48 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Fatigue - no symptoms
|
3 Participants
|
3 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Fatigue - mild symptoms
|
17 Participants
|
13 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Fatigue - moderate symptoms
|
43 Participants
|
16 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Fatigue - severe symptoms
|
36 Participants
|
16 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Brain fog - no symptoms
|
7 Participants
|
2 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Brain fog - mild symptoms
|
36 Participants
|
19 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Brain fog - moderate symptoms
|
34 Participants
|
18 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Brain fog - severe symptoms
|
22 Participants
|
9 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Dyspnea - no symptoms
|
31 Participants
|
12 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Dyspnea - mild symptoms
|
40 Participants
|
20 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Dyspnea - moderate symptoms
|
22 Participants
|
12 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Dyspnea - severe symptoms
|
6 Participants
|
4 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Body aches - no symptoms
|
21 Participants
|
16 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Body aches - mild symptoms
|
35 Participants
|
15 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Body aches - moderate symptoms
|
31 Participants
|
13 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Body aches - severe symptoms
|
12 Participants
|
4 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Gastrointestinal symptoms - no symptoms
|
24 Participants
|
12 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Gastrointestinal symptoms - mild symptoms
|
27 Participants
|
14 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Gastrointestinal symptoms - moderate symptoms
|
35 Participants
|
18 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Gastrointestinal symptoms - severe symptoms
|
13 Participants
|
4 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Cardiovascular symptoms - no symptoms
|
29 Participants
|
13 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Cardiovascular symptoms - mild symptoms
|
34 Participants
|
12 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Cardiovascular symptoms - moderate symptoms
|
28 Participants
|
13 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score
Cardiovascular symptoms - severe symptoms
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline through week 10, assessed at week 10Population: Missing data were imputed for statistical analysis, including for participants who were withdrawn prior to week 10
Relief defined as reduction of severity from moderate to none, or severe to mild/none (≥ 2-point Likert score change). Likert score range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms.
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Number of Participants Reporting Relief of at Least One Core Symptom for 2 Weeks
|
33 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline through week 10, assessed at week 10Population: Missing data were imputed for statistical analysis, including for participants who were withdrawn prior to week 10
Overall alleviation defined as both: 1. Any core symptom(s) that are none/mild (Likert 0 or 1) at baseline are none at 10 weeks, and 2. Any core symptom(s) that are moderate/severe (Likert 2 or 3) at baseline are none/mild at 10 weeks. Likert score range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms.
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Number of Participants With Overall Alleviation for 2 Weeks
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Assessed at weeks 5, 10, and 15Population: Missing data were imputed for statistical analysis, including for participants who were withdrawn prior to the respective data collection time point.
This outcome was to assess the severity of the most bothersome symptom experienced by participants. Each symptom was assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms) using the Core Symptoms Severity Scale.
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom
Week 5 - no symptoms
|
0 Participants
|
1 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom
Week 5 - mild symptoms
|
17 Participants
|
12 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom
Week 5 - moderate symptoms
|
41 Participants
|
18 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom
Week 5 - severe symptoms
|
34 Participants
|
13 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom
Missing symptoms data at week 5
|
10 Participants
|
9 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom
Week 10 - no symptoms
|
3 Participants
|
2 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom
Week 10 - mild symptoms
|
22 Participants
|
17 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom
Week 10 - moderate symptoms
|
34 Participants
|
18 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom
Week 10 - severe symptoms
|
39 Participants
|
11 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom
Missing symptoms data at week 10
|
4 Participants
|
5 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom
Week 15 - no symptoms
|
2 Participants
|
3 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom
Week 15 - mild symptoms
|
27 Participants
|
20 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom
Week 15 - moderate symptoms
|
32 Participants
|
17 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom
Week 15 - severe symptoms
|
37 Participants
|
7 Participants
|
|
Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom
Missing symptoms data at week 15
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 15 weeksRelief defined as reduction of severity from moderate to none, or severe to mild/none for 2 consecutive weeks (≥ 2-point Likert score change). Likert score range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms.
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Time to Relief of the 6 Core Symptoms
Fatigue
|
15 weeks
Interval 15.0 to 15.0
|
15 weeks
Interval 15.0 to 15.0
|
|
Time to Relief of the 6 Core Symptoms
Brain fog
|
15 weeks
Interval 15.0 to 15.0
|
15 weeks
Interval 15.0 to 15.0
|
|
Time to Relief of the 6 Core Symptoms
Body aches
|
15 weeks
Interval 15.0 to 15.0
|
15 weeks
Interval 15.0 to 15.0
|
|
Time to Relief of the 6 Core Symptoms
Cardiovascular symptoms
|
15 weeks
Interval 15.0 to 15.0
|
15 weeks
Interval 15.0 to 15.0
|
|
Time to Relief of the 6 Core Symptoms
Shortness of breath
|
15 weeks
Interval 15.0 to 15.0
|
15 weeks
Interval 15.0 to 15.0
|
|
Time to Relief of the 6 Core Symptoms
Gastrointestinal symptoms
|
15 weeks
Interval 15.0 to 15.0
|
15 weeks
Interval 15.0 to 15.0
|
SECONDARY outcome
Timeframe: Up to 15 weeksRelief defined as reduction of severity from moderate to none, or severe to mild/none for 2 consecutive weeks (≥ 2-point Likert score change). Likert score range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms.
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Time to Relief of the Most Bothersome Symptom
|
15 weeks
Interval 15.0 to 15.0
|
15 weeks
Interval 5.0 to 15.0
|
SECONDARY outcome
Timeframe: Baseline and week 10Population: Missing data were imputed for statistical analysis, including for participants who were withdrawn prior to week 10
The PROMIS-Physical Function Short Form (SF) assesses difficulty level performing activities of daily living such as doing chores, climbing stairs, walking, and running errands. The assessment consists of 4 items (questions) with each item scored on 5-point Likert scale (higher scores correspond to better physical function). Scores are computed to a T-score metric, where 50 represents the mean for US general adult population and 10 is the standard deviation. A higher physical function T-score indicates better physical function.
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function T-Score
Baseline
|
37.97 T-score
Standard Deviation 6.26
|
38.98 T-score
Standard Deviation 8.71
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function T-Score
Change at week 10
|
2.73 T-score
Standard Deviation 6.62
|
1.32 T-score
Standard Deviation 5.75
|
SECONDARY outcome
Timeframe: Baseline and week 10Population: Missing data were imputed for statistical analysis, including for participants who were withdrawn prior to week 10
The PROMIS Fatigue Score assesses level of fatigue and its interference on daily activities. The assessment consists of 7 items (questions) with each item scored on 5-point Likert scale (higher scores correspond to more fatigue). Scores are computed to a T-score metric, where 50 represents the mean for US general adult population and 10 is the standard deviation. A higher fatigue T-score indicates greater fatigue.
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Change in PROMIS Fatigue T-Score
Baseline
|
66.00 T-score
Standard Deviation 6.42
|
64.00 T-score
Standard Deviation 6.45
|
|
Change in PROMIS Fatigue T-Score
Change at week 10
|
-3.92 T-score
Standard Deviation 7.88
|
-4.05 T-score
Standard Deviation 5.90
|
SECONDARY outcome
Timeframe: Baseline and week 10Population: Missing data were imputed for statistical analysis, including for participants who were withdrawn prior to week 10
The PROMIS-Fatigue Dyspnea-Severity Short Form assesses shortness of breath and its interference on daily activities. The assessment consists of 5 items (questions) scored on 4-point Likert scale with a 7-day recall period (higher scores correspond to worse symptoms). Scores are computed to a T-score metric, where 50 represents the mean for US general adult population and 10 is the standard deviation. A higher Dyspnea-Severity T-score indicates worse symptoms.
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Change in PROMIS Dyspnea-Severity T-Score
Baseline
|
52.18 T-score
Standard Deviation 7.49
|
52.59 T-score
Standard Deviation 8.67
|
|
Change in PROMIS Dyspnea-Severity T-Score
Change at week 10
|
-1.96 T-score
Standard Deviation 7.90
|
-2.38 T-score
Standard Deviation 6.13
|
SECONDARY outcome
Timeframe: Baseline and week 10Population: Missing data were imputed for statistical analysis, including for participants who were withdrawn prior to week 10
The PROMIS-Cognitive Function Abilities Short Form assesses brain fog and its interference on daily activities. The assessment consists of 4 items scored on 5-point Likert scale with a 7-day recall period (higher scores indicate better cognitive function). Scores are computed to a T-score metric, where 50 represents the mean for US general adult population and 10 is the standard deviation. A higher Cognitive Function T-score indicates better cognitive function.
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Change in PROMIS Cognitive Function Abilities T-Score
Baseline
|
35.78 T-score
Standard Deviation 7.90
|
39.09 T-score
Standard Deviation 6.84
|
|
Change in PROMIS Cognitive Function Abilities T-Score
Change at week 10
|
4.84 T-score
Standard Deviation 8.18
|
5.05 T-score
Standard Deviation 7.56
|
SECONDARY outcome
Timeframe: Baseline and week 10Population: Missing data were imputed for statistical analysis, including for participants who were withdrawn prior to week 10
This outcome measures the difference in supine to standing systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Change in Orthostatic Vitals Test
SBP - baseline
|
1.79 mmHg
Standard Deviation 12.52
|
3.77 mmHg
Standard Deviation 12.15
|
|
Change in Orthostatic Vitals Test
SBP - change at week 10
|
-2.86 mmHg
Standard Deviation 15.9
|
-4.47 mmHg
Standard Deviation 14.1
|
|
Change in Orthostatic Vitals Test
DBP - baseline
|
6.26 mmHg
Standard Deviation 8.36
|
6.43 mmHg
Standard Deviation 10.90
|
|
Change in Orthostatic Vitals Test
DBP - change at week 10
|
-1.86 mmHg
Standard Deviation 1.9
|
-1.51 mmHg
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: Baseline and week 10Population: Missing data were imputed for statistical analysis, including for participants who were withdrawn prior to week 10
This outcome measures the difference in supine to standing heart rate.
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Change in Heart Rate
Baseline
|
6.22 bpm
Standard Deviation 11.92
|
7.70 bpm
Standard Deviation 8.39
|
|
Change in Heart Rate
Change at week 10
|
0.878 bpm
Standard Deviation 14.2
|
1.4 bpm
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Baseline and week 10Population: Missing data were imputed for statistical analysis, including for participants who were withdrawn prior to week 10
Number of times participant is able to go from sitting (in an armless chair) to standing in 1 minute (sit to stand cycles).
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Change in 1-minute Sit-to-stand Test
Baseline
|
20.48 cycles
Standard Deviation 10.69
|
20.51 cycles
Standard Deviation 9.80
|
|
Change in 1-minute Sit-to-stand Test
Change at week 10
|
2.67 cycles
Standard Deviation 10.8
|
3.27 cycles
Standard Deviation 7.25
|
SECONDARY outcome
Timeframe: Day 15, and weeks 5, 10, and 15Population: Missing data were imputed for statistical analysis, including for participants who were withdrawn prior to the respective data collection time point.
The PGIS reflects a participant's perception about the overall severity of their disease symptoms, rated from 1 to 6 (1 = not present; 2 = very mild; 3 = mild; 4 = moderate; 5 = severe; 6 = extremely severe).
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Patient Global Impression of Severity (PGIS) Scale Score
Day 15
|
4.04 score on a scale
Standard Deviation 0.98
|
3.72 score on a scale
Standard Deviation 1.02
|
|
Patient Global Impression of Severity (PGIS) Scale Score
Week 5
|
4.01 score on a scale
Standard Deviation 0.99
|
3.73 score on a scale
Standard Deviation 1.02
|
|
Patient Global Impression of Severity (PGIS) Scale Score
Week 10
|
4.00 score on a scale
Standard Deviation 1.03
|
3.79 score on a scale
Standard Deviation 1.06
|
|
Patient Global Impression of Severity (PGIS) Scale Score
Week 15
|
3.94 score on a scale
Standard Deviation 1.03
|
3.62 score on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Day 15, and weeks 5, 10, and 15Population: Missing data were imputed for statistical analysis, including for participants who were withdrawn prior to the respective data collection time point.
The PGIC reflects a participant's perception about the overall efficacy of treatment and their overall status since the start of the treatment, rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse).
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Patient Global Impression of Change (PGIC) Scale Score
Day 15
|
3.74 score on a scale
Standard Deviation 1.22
|
3.51 score on a scale
Standard Deviation 1.08
|
|
Patient Global Impression of Change (PGIC) Scale Score
Week 5
|
3.52 score on a scale
Standard Deviation 1.29
|
3.59 score on a scale
Standard Deviation 1.13
|
|
Patient Global Impression of Change (PGIC) Scale Score
Week 10
|
3.38 score on a scale
Standard Deviation 1.31
|
3.13 score on a scale
Standard Deviation 1.03
|
|
Patient Global Impression of Change (PGIC) Scale Score
Week 15
|
3.38 score on a scale
Standard Deviation 1.42
|
3.09 score on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Weeks 5, 10, and 15Population: Missing data were imputed for statistical analysis, including for participants who were withdrawn prior to the respective data collection time point.
Core Symptoms Severity Scale Scores for each of the 6 core symptoms were summed to create a summative score. Each core symptom is assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Summative score range: 0 to 18 (high scores correspond to greater severity).
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Summative Severity Score for All Core Symptoms
Week 5
|
8.40 score on a scale
Standard Deviation 3.56
|
8.20 score on a scale
Standard Deviation 3.88
|
|
Summative Severity Score for All Core Symptoms
Week 10
|
7.62 score on a scale
Standard Deviation 3.75
|
7.69 score on a scale
Standard Deviation 4.09
|
|
Summative Severity Score for All Core Symptoms
Week 15
|
7.90 score on a scale
Standard Deviation 3.80
|
7.09 score on a scale
Standard Deviation 4.15
|
SECONDARY outcome
Timeframe: 15 weeksPopulation: Missing data were imputed for statistical analysis, including for participants who were withdrawn prior to week 15.
Each symptom (fatigue, brain fog, dyspnea, body aches, gastrointestinal symptoms, cardiovascular symptoms) is assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).
Outcome measures
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 Participants
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 Participants
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Percentage of Weeks 1-15 With Mild or no Symptoms
Fatigue
|
0.15 percentage of weeks
Interval 0.0 to 0.39
|
0.15 percentage of weeks
Interval 0.0 to 0.77
|
|
Percentage of Weeks 1-15 With Mild or no Symptoms
Brain fog
|
0.31 percentage of weeks
Interval 0.0 to 0.75
|
0.56 percentage of weeks
Interval 0.15 to 0.85
|
|
Percentage of Weeks 1-15 With Mild or no Symptoms
Body Aches
|
0.54 percentage of weeks
Interval 0.1 to 0.92
|
0.64 percentage of weeks
Interval 0.29 to 0.83
|
|
Percentage of Weeks 1-15 With Mild or no Symptoms
Cardiovascular symptoms
|
0.67 percentage of weeks
Interval 0.19 to 0.92
|
0.46 percentage of weeks
Interval 0.0 to 0.92
|
|
Percentage of Weeks 1-15 With Mild or no Symptoms
Shortness of breath
|
0.769 percentage of weeks
Interval 0.25 to 1.0
|
0.62 percentage of weeks
Interval 0.09 to 0.89
|
|
Percentage of Weeks 1-15 With Mild or no Symptoms
Gastrointestinal symptoms
|
0.63 percentage of weeks
Interval 0.31 to 0.92
|
0.52 percentage of weeks
Interval 0.28 to 0.9
|
Adverse Events
Nirmatrelvir Plus Ritonavir
Serious events: 3 serious events
Other events: 100 other events
Deaths: 0 deaths
Placebo Plus Ritonavir
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 participants at risk
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 participants at risk
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood-loss anemia
|
0.98%
1/102 • 15 weeks
|
0.00%
0/53 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Forearm fracture
|
0.98%
1/102 • 15 weeks
|
0.00%
0/53 • 15 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma
|
0.98%
1/102 • 15 weeks
|
0.00%
0/53 • 15 weeks
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/102 • 15 weeks
|
1.9%
1/53 • 15 weeks
|
Other adverse events
| Measure |
Nirmatrelvir Plus Ritonavir
n=102 participants at risk
Participants receive nirmatrelvir (two 150 mg tablets) plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
Placebo Plus Ritonavir
n=53 participants at risk
Participants receive placebo to match nirmatrelvir plus ritonavir (one 100 mg capsule) every 12 hours for 15 days, and attend follow-up visits through week 15.
|
|---|---|---|
|
Cardiac disorders
palpitations
|
11.8%
12/102 • 15 weeks
|
13.2%
7/53 • 15 weeks
|
|
Cardiac disorders
tachycardia
|
2.0%
2/102 • 15 weeks
|
7.5%
4/53 • 15 weeks
|
|
Eye disorders
vision blurred
|
3.9%
4/102 • 15 weeks
|
7.5%
4/53 • 15 weeks
|
|
Gastrointestinal disorders
abdominal discomfort
|
8.8%
9/102 • 15 weeks
|
0.00%
0/53 • 15 weeks
|
|
Gastrointestinal disorders
abdominal distension
|
5.9%
6/102 • 15 weeks
|
5.7%
3/53 • 15 weeks
|
|
Gastrointestinal disorders
abdominal pain
|
20.6%
21/102 • 15 weeks
|
22.6%
12/53 • 15 weeks
|
|
Gastrointestinal disorders
constipation
|
8.8%
9/102 • 15 weeks
|
11.3%
6/53 • 15 weeks
|
|
Gastrointestinal disorders
diarrhoea
|
50.0%
51/102 • 15 weeks
|
39.6%
21/53 • 15 weeks
|
|
Gastrointestinal disorders
dry mouth
|
4.9%
5/102 • 15 weeks
|
5.7%
3/53 • 15 weeks
|
|
Gastrointestinal disorders
gastrooesophageal reflux disease
|
5.9%
6/102 • 15 weeks
|
3.8%
2/53 • 15 weeks
|
|
Gastrointestinal disorders
nausea
|
25.5%
26/102 • 15 weeks
|
26.4%
14/53 • 15 weeks
|
|
General disorders
chest pain
|
16.7%
17/102 • 15 weeks
|
9.4%
5/53 • 15 weeks
|
|
General disorders
fatigue
|
35.3%
36/102 • 15 weeks
|
28.3%
15/53 • 15 weeks
|
|
General disorders
malaise
|
5.9%
6/102 • 15 weeks
|
1.9%
1/53 • 15 weeks
|
|
General disorders
pyrexia
|
8.8%
9/102 • 15 weeks
|
22.6%
12/53 • 15 weeks
|
|
Infections and infestations
covid-19
|
11.8%
12/102 • 15 weeks
|
9.4%
5/53 • 15 weeks
|
|
Infections and infestations
upper respiratory tract infection
|
7.8%
8/102 • 15 weeks
|
3.8%
2/53 • 15 weeks
|
|
Infections and infestations
viral infection
|
0.98%
1/102 • 15 weeks
|
11.3%
6/53 • 15 weeks
|
|
Investigations
fibrin d dimer increased
|
4.9%
5/102 • 15 weeks
|
5.7%
3/53 • 15 weeks
|
|
Metabolism and nutrition disorders
decreased appetite
|
21.6%
22/102 • 15 weeks
|
20.8%
11/53 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
5.9%
6/102 • 15 weeks
|
0.00%
0/53 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
28.4%
29/102 • 15 weeks
|
24.5%
13/53 • 15 weeks
|
|
Nervous system disorders
brain fog
|
17.6%
18/102 • 15 weeks
|
17.0%
9/53 • 15 weeks
|
|
Nervous system disorders
dizziness
|
16.7%
17/102 • 15 weeks
|
22.6%
12/53 • 15 weeks
|
|
Nervous system disorders
dysgeusia
|
61.8%
63/102 • 15 weeks
|
7.5%
4/53 • 15 weeks
|
|
Nervous system disorders
headache
|
44.1%
45/102 • 15 weeks
|
24.5%
13/53 • 15 weeks
|
|
Nervous system disorders
peripheral sensory neuropathy
|
7.8%
8/102 • 15 weeks
|
9.4%
5/53 • 15 weeks
|
|
Psychiatric disorders
insomnia
|
16.7%
17/102 • 15 weeks
|
15.1%
8/53 • 15 weeks
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
13.7%
14/102 • 15 weeks
|
13.2%
7/53 • 15 weeks
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
24.5%
25/102 • 15 weeks
|
15.1%
8/53 • 15 weeks
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
3.9%
4/102 • 15 weeks
|
13.2%
7/53 • 15 weeks
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
15.7%
16/102 • 15 weeks
|
24.5%
13/53 • 15 weeks
|
|
Skin and subcutaneous tissue disorders
rash
|
5.9%
6/102 • 15 weeks
|
5.7%
3/53 • 15 weeks
|
|
Vascular disorders
hypertension
|
6.9%
7/102 • 15 weeks
|
3.8%
2/53 • 15 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place