Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19
Public ClinicalTrials.gov record NCT04425629. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients With COVID-19
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Phase 1 * To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo * To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 Phase 2 • To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 Phase 3 * Cohort 1 (≥18 Years Old, Not Pregnant at Randomization) • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo as measured by COVID-19-related hospitalizations or all-cause death * Cohort 2 (\<18 Years Old, Not Pregnant at Randomization) * To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo * To further characterize the concentrations of REGN10933 and REGN10987 in serum over time * Cohort 3 (Pregnant at Randomization) • To evaluate the safety and tolerability of REGN10933+REGN10987
Study identification
- NCT ID
- NCT04425629
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 10,078 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 16, 2020 (Actual)
- Primary completion
- Jan 21, 2022 (Actual)
- Completion
- Jun 9, 2022 (Actual)
- Last update posted
- Dec 21, 2023
2020 – 2022
United States locations
- U.S. sites
- 102
- U.S. states
- 27
- U.S. cities
- 74
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Study Site | Mesa | Arizona | 85210 | — |
| Regeneron Study Site | Tucson | Arizona | 85712 | — |
| Regeneron Study Site | Tucson | Arizona | 85724 | — |
| Regeneron Study Site | Canoga Park | California | 91303 | — |
| Regeneron Study Site | La Mesa | California | 91942 | — |
| Regeneron Study Site | La Palma | California | 90623 | — |
| Regeneron Study Site 1 | Long Beach | California | 90806 | — |
| Regeneron Study Site 2 | Long Beach | California | 90806 | — |
| Regeneron Study Site 3 | Long Beach | California | 90806 | — |
| Regeneron Study Site | Los Angeles | California | 90036 | — |
| Regeneron Study Site | Montclair | California | 91763 | — |
| Regeneron Study Site | Rolling Hills Estates | California | 90274 | — |
| Regeneron Study Site | Sacramento | California | 95817 | — |
| Regeneron Study Site | San Francisco | California | 94127 | — |
| Regeneron Study Site | Santa Monica | California | 90404 | — |
| Regeneron Study Site | Stanford | California | 94305 | — |
| Regeneron Study Site | Aurora | Colorado | 80045 | — |
| Regeneron Study Site | Colorado Springs | Colorado | 80907 | — |
| Regeneron Study Site | Washington D.C. | District of Columbia | 20037 | — |
| Regeneron Study Site | Boca Raton | Florida | 33487 | — |
| Regeneron Study Site | DeLand | Florida | 32720 | — |
| Regeneron Study Site | Ft. Pierce | Florida | 34982 | — |
| Regeneron Study Site | Hialeah | Florida | 33010 | — |
| Regeneron Study Site | Loxahatchee Groves | Florida | 33470 | — |
| Regeneron Study Site | Maitland | Florida | 32751 | — |
| Regeneron Study Site | Miami | Florida | 33012 | — |
| Regeneron Study Site 1 | Miami | Florida | 33126 | — |
| Regeneron Study Site 2 | Miami | Florida | 33126 | — |
| Regeneron Study Site | Miami | Florida | 33130 | — |
| Regeneron Study Site | Miami | Florida | 33144 | — |
| Regeneron Study Site | Miami | Florida | 33184 | — |
| Regeneron Study Site | Sarasota | Florida | 34239 | — |
| Regeneron Study Site | St. Petersburg | Florida | 33705 | — |
| Regeneron Study Site | Tampa | Florida | 33606 | — |
| Regeneron Study Site | West Palm Beach | Florida | 33407 | — |
| Regeneron Study Site | Winter Haven | Florida | 33880 | — |
| Regeneron Study Site | Winter Park | Florida | 32789 | — |
| Regeneron Study Site | Atlanta | Georgia | 30309 | — |
| Regeneron Study Site | Atlanta | Georgia | 30322 | — |
| Regeneron Study Site | Augusta | Georgia | 30912 | — |
| Regeneron Study Site | Columbus | Georgia | 31904 | — |
| Regeneron Study Site | Marietta | Georgia | 30060 | — |
| Regeneron Study Site | Chicago | Illinois | 60607 | — |
| Regeneron Study Site 1 | Downers Grove | Illinois | 60515 | — |
| Regeneron Study Site 2 | Downers Grove | Illinois | 60515 | — |
| Regeneron Study Site | Downers Grove | Illinois | 60515 | — |
| Regeneron Study Site | Ames | Iowa | 50010-3014 | — |
| Regeneron Study Site | Iowa City | Iowa | 52242 | — |
| Regeneron Study Site | Lake Charles | Louisiana | 70601 | — |
| Regeneron Study Site | Marrero | Louisiana | 70072 | — |
| Regeneron Study Site | New Orleans | Louisiana | 70114 | — |
| Regeneron Study Site | Shreveport | Louisiana | 71118 | — |
| Regeneron Study Site | Baltimore | Maryland | 21201 | — |
| Regeneron Study Site | Royal Oak | Michigan | 48073 | — |
| Regeneron Study Site | Jackson | Mississippi | 39216 | — |
| Regeneron Study Site | Las Vegas | Nevada | 89109 | — |
| Regeneron Study Site | Ridgewood | New Jersey | 07450 | — |
| Regeneron Study Site | Teaneck | New Jersey | 07666 | — |
| Regeneron Study Site | Santa Fe | New Mexico | 87505 | — |
| Regeneron Study Site | Jamaica | New York | 11432 | — |
| Regeneron Study Site | New York | New York | 10003 | — |
| Regeneron Study Site | New York | New York | 10019 | — |
| Regeneron Study Site | New York | New York | 10025 | — |
| Regeneron Study Site | New York | New York | 10029 | — |
| Regeneron Study Site | New York | New York | 10032 | — |
| Regeneron Study Site | New York | New York | 10037 | — |
| Regeneron Study Site | The Bronx | New York | 10451 | — |
| Regeneron Study Site | The Bronx | New York | 10461 | — |
| Regeneron Study Site | Charlotte | North Carolina | 28209 | — |
| Regeneron Study Site | Durham | North Carolina | 27710 | — |
| Regeneron Study Site | Wilmington | North Carolina | 28401 | — |
| Regeneron Study Site | Columbus | Ohio | 43215 | — |
| Regeneron Study Site | Dayton | Ohio | 45409 | — |
| Regeneron Study Site | Dayton | Ohio | 45432 | — |
| Regeneron Study Site | Philadelphia | Pennsylvania | 19140 | — |
| Regeneron Study Site | Providence | Rhode Island | 02903 | — |
| Regeneron Study Site | Charleston | South Carolina | 29425 | — |
| Regeneron Study Site | Clinton | South Carolina | 29325 | — |
| Regeneron Study Site | Sioux Falls | South Dakota | 57108 | — |
| Regeneron Study Site 2 | Memphis | Tennessee | 38103 | — |
| Regeneron Study Site | Memphis | Tennessee | 38103 | — |
| Regeneron Study Site | Amarillo | Texas | 79109 | — |
| Regeneron Study Site | Corpus Christi | Texas | 78413 | — |
| Regeneron Study Site | Dallas | Texas | 75246 | — |
| Regeneron Study Site | Dallas | Texas | 75390 | — |
| Regeneron Study Site | Houston | Texas | 77004 | — |
| Regeneron Study Site | Houston | Texas | 77008 | — |
| Regeneron Study Site | Houston | Texas | 77030 | — |
| Regeneron Study Site | Houston | Texas | 77055 | — |
| Regeneron Study Site | Houston | Texas | 77057 | — |
| Regeneron Study Site | Houston | Texas | 77093 | — |
| Regeneron Study Site | Pearland | Texas | 77584 | — |
| Regeneron Study Site | Red Oak | Texas | 75154 | — |
| Regeneron Study Site | San Antonio | Texas | 78215 | — |
| Regeneron Study Site | San Antonio | Texas | 78217 | — |
| Regeneron Study Site | San Antonio | Texas | 78249 | — |
| Regeneron Study Site | Tyler | Texas | 75708 | — |
| Regeneron Study Site | Falls Church | Virginia | 22042 | — |
| Regeneron Study Site | Everett | Washington | 98201 | — |
| Regeneron Study Site | Seattle | Washington | 98109 | — |
| Regeneron Study Site | Seattle | Washington | 98122 | — |
| Regeneron Study Site | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04425629, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 21, 2023 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04425629 live on ClinicalTrials.gov.