Study design
SCORPIO-PEP: The first oral antiviral trial to meet the primary endpoint of preventing symptomatic* COVID-19 after exposure1-4
SCORPIO-PEP was a randomized, double-blind, placebo-controlled, multinational Phase 3 trial conducted in 5 countries evaluating XOCOVA in asymptomatic standard- or high-risk participants 12 years of age or older considered not to have SARS-CoV-2 infection.1,5
2387 participants were randomized 1:1 to receive either XOCOVA or placebo for 5 days, then subsequently tested through Day 281,5†
*Defined as central-laboratory–confirmed RT-PCR positivity of SARS-CoV-2 and ≥1 of the 14 COVID-19 symptoms lasting ≥48 hours.5
†Nasopharyngeal swabs were collected on Days 1, 3, 6, 10, 15, 21, and 28 for RT-PCR testing of participants taking XOCOVA or placebo.5
Criteria for symptomatic COVID-19
Defined as central-laboratory–confirmed RT-PCR positivity of SARS-CoV-2 and ≥1 of the following 14 prespecified COVID-19 symptoms lasting ≥48 hours5,6:
- 1.Fever
- 2.Shortness of breath or difficulty breathing
- 3.Cough
- 4.Sore throat
- 5.Nasal congestion or runny nose
- 6.Chills
- 7.Fatigue
- 8.Body or muscle pain or aches
- 9.Headache
- 10.Nausea
- 11.Vomiting
- 12.Diarrhea
- 13.Change in sense of taste
- 14.Change in sense of smell
XOCOVA was studied in a broad range of patients5
Baseline characteristics were similar in the XOCOVA and placebo groups5
Baseline characteristics (mITT population)5,6
| Characteristic | XOCOVA(n=1030) | Placebo(n=1011) |
|---|---|---|
| Age—yr, mean (SD) | 41.8 (16.9) | 43.0 (16.1) |
| ≥65, n (%) | 99 (9.6) | 90 (8.9) |
| Female, n (%) | 584 (56.7) | 627 (62.0) |
| BMI—kg/m2, mean (SD) | 26.4 (5.7) | 26.6 (5.3) |
| Hispanic or Latino, n (%)‡ | 620 (60.2) | 623 (61.6) |
| Race, n (%)‡ | ||
| White | 632 (61.4) | 615 (60.8) |
| Black or African American | 51 (5.0) | 56 (5.5) |
| Asian | 325 (31.6) | 321 (31.8) |
| American Indian or Alaska Native | 2 (0.2) | 4 (0.4) |
| Other | 20 (1.9) | 15 (1.5) |
| Risk status, n (%) | ||
| High risk§ | 382 (37.1) | 374 (37.0) |
| Non-high risk | 648 (62.9) | 637 (63.0) |
| Hours from symptom onset in the CP to enrollment of SP, n (%) | ||
| <48 | 732 (71.1) | 720 (71.2) |
| Geographic region, n (%) | ||
| US | 692 (67.2) | 683 (67.6) |
| South America | 7 (0.7) | 4 (0.4) |
| Africa | 6 (0.6) | 5 (0.5) |
| Asia (except Japan) | 59 (5.7) | 49 (4.8) |
| Japan | 266 (25.8) | 270 (26.7) |
| Positive baseline serology, n (%)|| | ||
| S-antibody | 1018 (99.4) | 1004 (99.7) |
| N-antibody | 1002 (97.9) | 985 (98.0) |
‡Race and ethnic group were reported by the participant.5
§Some high-risk factors for severe illness are obesity, cardiovascular disease, chronic lung disease, chronic kidney disease, chronic liver disease, Down syndrome, sickle-cell disease, immunocompromised conditions or treatment for immunocompromised conditions, dementia, diabetes mellitus, smoking, and history of stroke or cerebrovascular disease.5
||Percentages are based on the number of HHCs in the mITT analysis set who had definitive test results at screening Day 1, within each treatment group and overall. Number of HHCs with no missing serology data was used as denominator.6
BMI=body mass index; CP=COVID-positive patient; HHC=household contact; ITT=intention-to-treat; mITT=modified intention-to-treat; PEP=post-exposure prophylaxis; R=randomization; RT-PCR=reverse transcription polymerase chain reaction; SD=standard deviation; SP=study participant.
Review the study results of early intervention against COVID-19 after exposure
