Trial · NCT04425629
Registered outcomes91
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 91
Download this page as JSON| 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) |
| Secondary | 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) | From Day 4 Through Day 29 | Phase 3 (Cohort 1) |
| Secondary | Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs (Next Phase 2 Cohort) | Day 5, Day 7, Day 15, Day 29 | Next Phase 2 Symptomatic |
| Secondary | Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Post-baseline Study Days (Ph1, Ph2) | Day 1 to Day 29 | Phase 1, Phase 2 |
| Secondary | Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit Through Day 29 (Ph1, Ph2) | Through Day 29 | Phase 1, Phase 2 |
| Secondary | Percentage of Participants With ≥1 COVID-19 Related Hospitalization, Emergency Room, or Urgent Care Visit Through Day 29 (Ph1, Ph2) | Through Day 29 | Phase 1, Phase 2 |
| Secondary | Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only) | Up to Day 29 | Phase 2 Only |
| Secondary | Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 1.2g IV | Through Day 29 | Phase 3 Cohort 1 - Placebo vs. 1.2 g IV |
| Secondary | Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 2.4g IV | Through day 29 | Phase 3 (Cohort 1) |
| Secondary | Concentration of REGN10933 + REGN10987 in Serum Over Time (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1 and Cohort 3) | Up to Nominal Sampling Day 28 | Secondary: Phase 1, Phase 2, Phase 3 (Cohort 1 and Cohort 3) - Symptomatic Participants \[Nominal Sampling Time\] = \[Clinical Study Time (Visit Day - 1)\] |
| Secondary | Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933+REGN10987 (Phase 1) | Through Day 29 | Phase 1 Only |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04425629/registered