Trial · NCT04354259
Registered outcomes46
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 46
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort A (Ambulatory) - Proportion swab negative at day 7 (Primary efficacy endpoint) | At day 7 | The proportion of participants with negative SARS-CoV-2 RNA on nasopharyngeal swab. |
| Primary | Cohort A (Ambulatory) - Treatment-emergent and treatment related serious adverse events (Primary Safety Endpoint) | Day 0 to Day 28 | The rate of treatment-emergent and treatment-related serious adverse events (SAEs) |
| Primary | Cohort B (Hospitalized) - Ordinal Scale (Primary Efficacy Endpoint) | At Day 14 | Clinical status on an ordinal scale at Day 14 |
| Primary | Cohort B (Hospitalized) - treatment-emergent and treatment-related serious adverse events (Primary Safety Endpoint) | Day 0 to Day 28 | The rate of treatment-emergent and treatment-related serious adverse events (SAEs) |
| Secondary | Cohort A (Ambulatory) - Symptom Resolution (Clinical Outcome #1) | Day 0 to Day 14 | Time to resolution of symptoms (fever, cough, diarrhea) |
| Secondary | Cohort A (Ambulatory) - Symptom severity scores (Clinical Outcome #2) | Day 0 to Day 7 | Change in relative categorical symptom scores (respiratory, gastrointestinal, fever) - none, mild, moderate, severe and no change, worse, better |
| Secondary | Cohort A (Ambulatory) - Hospitalization (Clinical Outcome #3) | Day 0 to Day 14 | Proportion with need for hospital admission |
| Secondary | Cohort A (Ambulatory) - Adverse and serious adverse events (Clinical Outcome #4) | Day 0 to Day 14 | Adverse events and serious adverse events |
| Secondary | Cohort A (Ambulatory) - Swab negative at day 3 (Virologic/Immunological Outcome #1) | At Day 3 | Proportion negative for SARS-CoV-2 RNA by nasopharyngeal swab |
| Secondary | Cohort A (Ambulatory) - Time RNA negativity (Virologic/Immunological Outcome #2) | Day 0 to Day 14 | Time to SARS-CoV-2 RNA negativity on mid-turbinate nasal swab or saliva |
| Secondary | Cohort A (Ambulatory) - Proportion viremic (Virologic/Immunological Outcome #3) | Day 0 and Day 7 | Proportion with SARS-CoV-2 RNA in blood. |
| Secondary | Cohort A (Ambulatory) - Proportion with antibodies (Virologic/Immunological Outcome #4) | Day 0 and Day 7 | Proportion with SARS-CoV-2 antibodies blood |
| Secondary | Cohort A (Ambulatory) - Correlation with interferon lambda 4 genotype (Virologic/Immunological Outcome #5) | Through day 7 | Correlation of virologic response with interferon lambda 4 (IFNL4) genotype |
| Secondary | Cohort A (Ambulatory) - Symptoms in household contacts (Transmission Outcome #1) | Day 0 to Day 14 | Proportion with symptom development in household contacts (categorical symptom type yes/no) |
| Secondary | Cohort A (Ambulatory) - COVID-19 in household contacts (Transmission Outcome #2) | At Day 30 | Proportion with confirmed diagnosis of COVID-19 in household contacts |
| Secondary | Cohort B (Hospitalized) - Ordinal scale (Clinical Outcome #1) | At Days 7, 21 and 28 | Clinical status on the ordinal scale |
| Secondary | Cohort B (Hospitalized) - ICU admission (Clinical Outcome #2) | Day 0 to day 28 | Proportion with ICU admission during hospitalization |
| Secondary | Cohort B (Hospitalized) - Need for intubation (Clinical Outcome #3) | Day 0 to Day 14 and to Day 28 | Proportion with need for intubation |
| Secondary | Cohort B (Hospitalized) - Length of hospital stay (Clinical Outcome #4) | Day 0 to Day 14 | Length of hospital stay (days) |
| Secondary | Cohort B (Hospitalized) - Change in respiratory symptom score (Clinical Outcome #5) | Day 0 to 7, Day 0 to 14, and Day 0 to 28 | Change in respiratory symptom score (score 0 to 7 with higher scores indicating more severe disease) |
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
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