Trial · NCT04425629
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
NCT04425629, Phase 3, Terminated, Regeneron Pharmaceuticals; results first posted 2023-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT04425629. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04425629
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT04425629
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 10,078 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- COVID-19
- Interventions
- casirivimab+imdevimab combination therapy
- First posted
- 2020-06-11
- Last updated
- 2023-12-21
- Other registries' IDs
- eudract:2020-003690-21
- Results first posted
- 2023-12-21
- Limitations and caveats
Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis, as such endpoints related to nasal or saliva samples were not analyzed. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
Source ClinicalTrials.gov
Registered outcomes91
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3] | Through Day 29 | Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1) |
| Primary | Number of Participants With Infusion-related Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3) | Through Day 4 | Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1) |
| Primary | Number of Participants With Hypersensitivity Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3) | Through Day 29 | Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1) |
| Primary | Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Day 7, as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph1, Ph2) | Baseline up to Day 7 | Primary: Phase 1, Phase 2 |
| Primary | Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo) | Through Day 29 | Phase 3 Cohort 1 |
| Primary | Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1 - 2.4g vs Placebo) | Through Day 29 | Primary: Phase 3 (Cohort 1) |
| Primary | Concentration of REGN10983 + REGN10987 in Serum Over Time (Ph3 Cohort 2) | Up to Nominal Sampling Day 28 | Phase 3 Cohort 2 \[Nominal Sampling Time\] = \[Clinical Study Time (Visit Day - 1)\] |
| Secondary | Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 1.2g vs Placebo) | Up to Day 29 | Phase 3 Cohort 1 |
| Secondary | Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 2.4g vs Placebo) | Through Day 29 | Phase 3 (Cohort 1) |
| Secondary | Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 1.2g vs. Placebo) | Day 4 thru Day 29 | Phase 3 (Cohort 1) |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 registered outcomesOutcomes91
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3] | Through Day 29 | Analysis populations were prespecified in the SAP. Pooled analyses were performed for symptomatic adult participants randomized in Phase 1, 2, or 3 (cohort 1) on or before 2/24/21 to placebo, R10933+R10987 1.2 g, 2.4 g, or 8.0 g IV. No phase 1 or 2 participants were randomized to R10933+R10987 1.2 g IV. Asymptomatic adult participants randomized to the asymptomatic cohort of phase 2, symptomatic pediatric / pregnant participants randomized in phase 3 to cohort 2 or 3 were analyzed separately | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Infusion-related Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3) | Through Day 4 | Analysis populations were prespecified in the SAP. Pooled analyses were performed for symptomatic adult participants randomized in Phase 1, 2, or 3 (cohort 1) on or before 2/24/21 to placebo, R10933+R10987 1.2 g, 2.4 g, or 8.0 g IV. No phase 1 or 2 participants were randomized to R10933+R10987 1.2 g IV. Asymptomatic adult participants randomized to the asymptomatic cohort of phase 2, symptomatic pediatric / pregnant participants randomized in phase 3 to cohort 2 or 3 were analyzed separately. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Hypersensitivity Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3) | Through Day 29 | Analysis populations were prespecified in the SAP. Pooled analyses were performed for symptomatic adult participants randomized in Phase 1, 2, or 3 (cohort 1) on or before 2/24/21 to placebo, R10933+R10987 1.2 g, 2.4 g, or 8.0 g IV. No phase 1 or 2 participants were randomized to R10933+R10987 1.2 g IV. Asymptomatic adult participants randomized to the asymptomatic cohort of phase 2, symptomatic pediatric / pregnant participants randomized in phase 3 to cohort 2 or 3 were analyzed separately. | Participants | NUMBER |
| PRIMARY | Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Day 7, as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph1, Ph2) | Baseline up to Day 7 | All randomized participants in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This pooled modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized). | log10 copies/mL | MEAN |
| PRIMARY | Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo) | Through Day 29 | Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline | Percentage of Participants | NUMBER |
| PRIMARY | Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1 - 2.4g vs Placebo) | Through Day 29 | Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline | Percentage of Participants | NUMBER |
| PRIMARY | Concentration of REGN10983 + REGN10987 in Serum Over Time (Ph3 Cohort 2) | Up to Nominal Sampling Day 28 | The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug | mg/L | MEAN |
| SECONDARY | Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 1.2g vs Placebo) | Up to Day 29 | Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline | Days | MEDIAN |
| SECONDARY | Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 2.4g vs Placebo) | Through Day 29 | Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline | Days | MEDIAN |
| SECONDARY | Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 1.2g vs. Placebo) | Day 4 thru Day 29 | Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline | Participants | NUMBER |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 outcomesResults by group367
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3] | Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (Placebo) | 97 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3] | Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4 IV) | 31 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3] | Combined Phases 1, 2, & 3 Cohort 1 Symptomatic (8.0 IV) | 19 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3] | Phase 2 Asymptomatic (Placebo) | 0 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3] | Phase 2 Asymptomatic (2.4g IV) | 0 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3] | Phase 2 Asymptomatic (8.0g IV) | 0 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3] | Phase 3 Cohort 1 (1.2g IV) Symptomatic | 14 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3] | Phase 3 Cohort 2 Pediatric (Placebo) | 0 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3] | Phase 3 Cohort 2 Pediatric (1.2g IV) | 2 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3] | Phase 3 Cohort 2 Pediatric (2.4g IV) | 0 | Participants |
1 to 10 of 367Source ClinicalTrials.gov
See all 367 results by groupParticipant flow57
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1 Symptomatic: Placebo | 24 | |
| Overall Study | STARTED | Phase 1 Symptomatic: 2.4 IV | 24 | |
| Overall Study | STARTED | Phase 1 Symptomatic: 8.0 IV | 24 | |
| Overall Study | STARTED | Phase 2 Symptomatic: Placebo | 242 | |
| Overall Study | STARTED | Phase 2 Symptomatic: 2.4 IV | 242 | |
| Overall Study | STARTED | Phase 2 Symptomatic: 8.0 IV | 243 | |
| Overall Study | STARTED | Phase 2 Asymptomatic: Placebo | 76 | |
| Overall Study | STARTED | Phase 2 Asymptomatic: 2.4 IV | 76 | |
| Overall Study | STARTED | Phase 2 Asymptomatic: 8.0 IV | 76 | |
| Overall Study | STARTED | Phase 3 Age>=18: Placebo | 2,378 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 participant flowAdverse events2,432
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Phase 1 Symptomatic Placebo | 0 | 24 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1 Symptomatic R10933+R10987 2.4g IV | 0 | 22 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1 Symptomatic R10933+R10987 8.0g IV | 0 | 23 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 Symptomatic Placebo | 0 | 238 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 Symptomatic R10933+R10987 2.4g IV | 0 | 236 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 Symptomatic R10933+R10987 8.0g IV | 0 | 237 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 Asymptomatic Placebo | 0 | 73 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 Asymptomatic R10933+R10987 2.4g IV | 0 | 74 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 Asymptomatic R10933+R10987 8.0g IV | 0 | 75 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 3 Age>=18 Placebo | 0 | 2,347 | 0 |
1 to 10 of 2,432Source ClinicalTrials.gov
See all 2,432 adverse eventsAdverse event totals57
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 Symptomatic Placebo | 0 | 24 |
| Total, all-cause mortality | Phase 1 Symptomatic R10933+R10987 2.4g IV | 0 | 22 |
| Total, all-cause mortality | Phase 1 Symptomatic R10933+R10987 8.0g IV | 0 | 23 |
| Total, all-cause mortality | Phase 2 Symptomatic Placebo | 0 | 238 |
| Total, all-cause mortality | Phase 2 Symptomatic R10933+R10987 2.4g IV | 0 | 236 |
| Total, all-cause mortality | Phase 2 Symptomatic R10933+R10987 8.0g IV | 0 | 237 |
| Total, all-cause mortality | Phase 2 Asymptomatic Placebo | 0 | 73 |
| Total, all-cause mortality | Phase 2 Asymptomatic R10933+R10987 2.4g IV | 0 | 74 |
| Total, all-cause mortality | Phase 2 Asymptomatic R10933+R10987 8.0g IV | 0 | 75 |
| Total, all-cause mortality | Phase 3 Age>=18 Placebo | 11 | 2,347 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Phase 3 Cohort 1 (2.4g IV) >= 18 vs Phase 3 Cohort 1 (Placebo) >=18: Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 2.4g vs. Placebo) | Trial comparisons |
Phase 3 Cohort 1 (1.2g IV) >= 18 vs Phase 3 Cohort 1 (Placebo) >=18: Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 1.2g IV | Trial comparisons |
Phase 3 Cohort 1 (2.4g IV) >= 18 vs Phase 3 Cohort 1 (Placebo) >=18: Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 2.4g IV | Trial comparisons |
Phase 3 Cohort 1 (1.2g IV) >= 18 vs Phase 3 Cohort 1 (Placebo) >=18: Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 1.2g vs. Placebo) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04425629
GET https://conductscience.org/api/trials/v1/NCT04425629/registered?page=2