Trial · NCT04452318
Outcomes56
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 56
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP | Up to 1 month | Seronegative modified full analysis set in Cohort A includes randomized subjects aged 12 years and older who are laboratory confirmed negative for SARS-CoV-2 and negative serostatus for SAS-CoV-2 antibodies at baseline | Percentage of Participants | NUMBER |
| PRIMARY | Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP | Up to 14 Days | Estimate of percent of participants meeting the criteria based on fixed categories | Percentage of Participants | NUMBER |
| PRIMARY | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | Up to 8 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP | Up to 1 month | Percentage of Participants | NUMBER | |
| SECONDARY | Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP | Up to 1 month | weeks | MEAN | |
| SECONDARY | Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP | Up to 1 month | weeks | MEAN | |
| SECONDARY | Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP | Up to 1 month | weeks | MEAN | |
| SECONDARY | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP | Up to 1 month | Estimate of percentage of participants meeting the criteria based on fixed categories | Percentage of Participants | NUMBER |
| SECONDARY | Cohort A: Percentage of Participants in Placebo Group With a RT-qPCR Confirmed SARS-CoV-2 Infection During the EAP With an Index Case Participating in Study R10933-10987-COV-2067 (NCT04425629) | Up to 1 month | Percentage of Participants | NUMBER | |
| SECONDARY | Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP | Up to 1 month | Percentage of participants | NUMBER | |
| SECONDARY | Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP | Up to 1 month | weeks | MEAN | |
| SECONDARY | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP | Up to 1 month | Estimate of percentage of participants meeting the criteria based on fixed categories | Percentage of participants | NUMBER |
| SECONDARY | Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP | Up to 1 month | weeks | MEAN | |
| SECONDARY | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP | Week 1, Week 2, Week 3, Week 4 | Percentage of participants | NUMBER | |
| SECONDARY | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP | Week 1, Week 2, Week 3, Week 4 | Estimate of percentage of participants meeting the criteria based on fixed categories | Percentage of participants | NUMBER |
| SECONDARY | Cohort A: Time-weighted Average of Viral Load From the First Positive SARS CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Third Weekly Visit After the First Positive Test During the EAP | Up to 1 month | log10 copies/mL | LEAST_SQUARES_MEAN | |
| SECONDARY | Cohort A: Time-weighted Average of Viral Load From the First Positive SARS-CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Second Weekly Visit After the First Positive Test During the EAP | Up to 1 month | log10 copies/mL | LEAST_SQUARES_MEAN | |
| SECONDARY | Cohort A: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Among Individuals With ≥1 RT-qPCR Positive That Has an Onset During the EAP | Up to 1 month | log10 copies/mL | LEAST_SQUARES_MEAN | |
| SECONDARY | Cohort A: SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Corresponding to the Onset of First Positive RT-qPCR During the EAP | Up to 1 month | log10 copies/mL | LEAST_SQUARES_MEAN | |
| SECONDARY | Cohort A: Area Under the Curve (AUC) in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP Until the First Confirmed Negative Test | Up to 1 month | log10 copies/milliLiter * days | MEAN |
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/NCT04452318/outcomes