Trial · NCT04425629
Registered outcomes91
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 40 of 91
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933+REGN10987 (Phase 1) | Through Day 29 | Phase 1 Only |
| Secondary | Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to Day 28 Concentration (AUC 0-28) for REGN10933+REGN10987 (Phase 1) | Through Day 29 | Phase 1 Only |
| Secondary | Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1) | Through Day 29 | Phase 1, Phase 2, Phase 3 (Cohort 1) - Pooled Symptomatic Participants |
| Secondary | Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph3 Cohort 2 - Cohort 3) | Through Day 29 | Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants |
| Secondary | Immunogenicity as Measured by ADA to REGN10987 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1) | Through Day 29 | Phase 1, Phase 2, Phase 3 (Cohort 1) - Pooled Symptomatic Participants |
| Secondary | Immunogenicity as Measured by ADA to REGN10987 (Ph3 Cohort 2 and Cohort 3) | Through Day 29 | Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants |
| Secondary | Immunogenicity as Measured by Neutralizing Antibodies (NAbs) to REGN10933 (Ph3 Cohort 2, Ph3 Cohort 3) | Through Day 29 | Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants (TE\&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay |
| Secondary | Immunogenicity as Measured by NAbs to REGN10987 (Ph3 Cohort 2 - Cohort 3) | Through Day 29 | Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants (TE\&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay |
| Secondary | Number of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Phase 3 Cohort 2) | Through Day 29 | Phase 3 (Cohort 2) |
| Secondary | Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit (Phase 1, Phase 2) | Through Day 29 | Phase 1, Phase 2 Medically-attended Visits include Hospitalizations, ER visits, Urgent Care Clinic visits, Outpatient/physician office/telemedicine visits |
| Secondary | Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 1.2g IV | Through Day 29 | Phase 3 (Cohort 1) |
| Secondary | Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 2.4g IV | Through Day 29 | Phase 3 Cohort 1 |
| Secondary | Total Number of COVID-19-related Medically-attended Visits (Phase 1 and Phase 2) | Through Day 29 | Phase 1 and Phase 2 |
| Secondary | Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933 and REGN10987 (Phase 1 Only) | Through Day 29 | Phase 1 Only |
| Secondary | Assessment of PK Parameter: Cmax-to-dose Ratio (Cmax/Dose) of REGN10933 and REGN10987 (Phase 1 Only) | Though Day 29 | Phase 1 Only |
| Secondary | Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933 and REGN10987 (Phase 1 Only) | Through Day 29 | Phase 1 Only |
| Secondary | Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to the Time of the Last Positive Concentration (AUClast) for REGN10933 - (Phase 1 Only) | Through Day 29 | Phase 1 Only - Tlast (Time of last quantifiable concentration) |
| Secondary | Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) | Day 4 Through Day 29 | Phase 3 Cohort 1 |
| Secondary | Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo) | Day 4 Through Day 29 | Phase 3 Cohort 1 |
| Secondary | Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) | Through Day 29 | Phase 3 Cohort 1 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT04425629/registered?page=2