Trial · NCT04859517
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP) | Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier | RT-PCR-confirmed symptomatic COVID-19 is determined by a positive central or local (in the absence of central test) RT-PCR test from a nasopharyngeal or saliva sample accompanied by protocol-defined COVID-19 symptoms occurring within 14 days from the sample collection date. Any COVID-19-related hospitalization with a positive local SARS-CoV-2 test (within 14 days) or all-cause death are counted toward the endpoint. |
| Primary | Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP) | Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier | RT-PCR-confirmed symptomatic COVID-19 is determined by a positive central or local (in the absence of central test) RT-PCR test from a nasopharyngeal or saliva sample accompanied by protocol-defined COVID-19 symptoms occurring within 14 days from the sample collection date. Any COVID-19-related hospitalization with a positive local SARS-CoV-2 test (within 14 days) or all-cause death are counted toward the endpoint. |
| Primary | Solicited Injection Site Reactions (PEP, PrEP) | Day 1 through Day 4 | Percentage of participants with at least one solicited injection site reaction |
| Primary | Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP) | Day 1 through 14 Months or 25Jul2022, whichever is earlier | Any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment; includes solicited injection site reactions |
| Secondary | Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP) | Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier | RT-PCR-confirmed symptomatic COVID-19 is determined by a positive central or local (in the absence of central test) RT-PCRtest from a nasopharyngeal or saliva sample accompanied by protocol-defined COVID-19 symptoms occurring within 14 days from the sample collection date. Any COVID-19-related hospitalization with a positive local SARS-CoV-2 test (within 14 days) or all-cause death are counted toward the endpoint. |
| Secondary | Percentage of Participants With SARS-CoV-2 Infection (Asymptomatic or Symptomatic) as Determined by Positive RT-PCR or Serology (PEP) | Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier | Participants with RT-PCR-confirmed symptomatic COVID-19 (protocol defined COVID-19 symptoms occurring within 14 days from the sample collection date of a positive central or local \[in the absence of central test\] RT-PCR, any COVID-19-related hospitalization with a positive local SARS-CoV-2 test \[within 14 days\], or all-cause death), central RT-PCR-confirmed SARS-CoV-2 infection, or central serology-confirmed SARS-CoV-2 infection with negative central serology at baseline. |
| Secondary | Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by RT-PCR (PEP) | Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier | Defined as having a central RT-qPCR-confirmed SARS-CoV-2 infection without having an RT-PCR-confirmed symptomatic COVID-19 outcome |
| Secondary | Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PEP) | Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier | Defined as having a central serology-confirmed SARS-CoV-2 infection (with a negative central serology test sample at baseline) and without having an RT-PCR-confirmed symptomatic COVID-19 outcome (including COVID-19-related hospitalization and all-cause death) |
| Secondary | Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PrEP) | Day 1 through 6 Months or emergence of Omicron (15-Dec-2021), whichever is earlier | Defined as having a central serology-confirmed SARS-CoV-2 infection (with a negative central serology test sample at baseline) and without having an RT-PCR-confirmed symptomatic COVID-19 outcome (including COVID-19-related hospitalization and all-cause death) |
| Secondary | SARS-CoV-2 Viral Load as Assessed by RT-qPCR Change From Baseline in Asymptomatic Participants (PEP) | Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier | Asymptomatic SARS-CoV-2 infection confirmed by RT-qPCR from nasal swab collected at Day 8 and Day 15. Viral load values reported as detected but below the lower quantification of the PCR assay (\< 714 copies/mL) are imputed with half the lower limit of quantification of the PCR assay (i.e., 357 copies/mL = 2.55 log10 copies/mL). Viral load values reported as \> 7.1×10\^7 copies/mL are imputed with 7.1×10\^7 copies/mL (i.e., 7.85 log10 copies/mL). |
| Secondary | Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP) | Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier | Maximum severity assessed from COVID-19-like illness (CLI) Day 1 through CLI Day 28. COVID-19-related hospitalizations or COVID-19-related deaths from CLI Day 1 to CLI Day 28 are categorized as severe/critical. |
| Secondary | Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP) | Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier | Maximum severity assessed from COVID-19-like Illness (CLI) Day 1 through CLI Day 28. COVID-19-related hospitalizations or COVID-19-related deaths from CLI Day 1 to CLI Day 28 are categorized as severe/critical. |
| Secondary | Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PEP) | Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier | Physician office, telemedicine, emergency room or urgent care center visits in participants with RT-PCR-confirmed symptomatic COVID-19 events, defined as having a central RT-PCR-confirmed SARS-CoV-2 infection with COVID-19 symptoms occurring within 14 days from the positive RT-PCR test sample collection, COVID-19-related hospitalization with a positive local or central SARS-CoV-2 test within 14 days, or all-cause death. |
| Secondary | Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PrEP) | Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier | Physician office, telemedicine, emergency room or urgent care center visits in participants with RT-PCR confirmed symptomatic COVID-19, defined as having a central RT-PCR-confirmed SARS-CoV-2 infection with COVID-19 symptoms occurring within 14 days from the positive RT-PCR test sample collection, COVID-19-related hospitalization with a positive local or central SARS-CoV-2 test within 14 days, or all-cause death. |
| Secondary | Percentage of Participants With a COVID-19 Related Hospitalization (PEP) | Through 28 Days from COVID-19-like illness initial visit (CLI Day 1) | |
| Secondary | Percentage of Participants With a COVID-19 Related Hospitalization (PrEP) | Through 28 days from COVID-19-like illness initial visit (CLI Day 1) | |
| Secondary | COVID-19 Related Mortality (PEP) | Through 28 Days from COVID-19-like illness initial visit (CLI Day 1) | |
| Secondary | COVID-19 Related Mortality (PrEP) | Through 28 Days from COVID-19-like illness initial visit (CLI Day 1) | |
| Secondary | All-Cause Mortality (PEP) | Through 28 Days from COVID-19-like illness initial visit (CLI Day 1) | |
| Secondary | All-Cause Mortality (PrEP) | Through 28 Days from COVID-19-like illness initial visit (CLI Day 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.
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