Trial · NCT04988217
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment-emergent adverse events in healthy subjects | At the end of Phase 1 (Phase 1 is 11 days) | Safety and tolerability of AP-003 as measured by subject incidence of treatment-emergent adverse events. |
| Primary | Change in perception of health status measured by EQ VAS in COVID-19 patients | At Day 5 of Phase 2 (Phase 2 is 28 days) | Changes from baseline evaluation in COVID-19(+) participants' perception of health status at Day 5 as measured by EQ VAS in AP-003 treated patients compared to placebo. |
| Secondary | Serum levels of interferon alpha 2b | Up to Day 11 of Phase 1 (Phase 1 is 11 days) | Pharmacokinetics of nebulized AP-003 in healthy adults assessed by serial serum quantification of interferon alpha 2b |
| Secondary | Expression of interferon-induced genes in blood sputum samples | Up to Day 11 of Phase 1 (Phase 1 is 11 days) | Evaluation of interferon-induced biomarkers after treatment with AP-003 in blood and sputum of healthy adults to assess biological effect of Interferon |
| Secondary | Change in perception of health status measured by EQ VAS | Day 10 of Phase 2 (Phase 2 is 28 days) | Changes in participants' perception of health status from baseline to Day 10 as measured by EQ VAS in AP-003 treated patients compared to placebo. |
| Secondary | Change in perception of health status measured by EQ VAS | Day 28 of Phase 2 (Phase 2 is 28 days) | Changes in participants' perception of health status from baseline to Day 28 as measured by EQ VAS in AP-003 treated patients compared to placebo. |
| Secondary | Change in EuroQoL Quality of Life instrument (EQ-5D-5L) | Up to day 28 of Phase 2 (Phase 2 is 28 days) | Changes in participants' perception of health status from baseline to Day 5, from baseline to Day 10, and from baseline to Day 28 as measured by EuroQoL Quality of Life instrument (EQ-5D-5L). |
| Secondary | Change in Ordinal Scale for Clinical Improvement | Up to day 28 of Phase 2 (Phase 2 is 28 days) | Changes in participants' overall health from baseline to Day 5, from baseline to Day 10, and from baseline to Day 28 as measured by Ordinal Scale for Clinical Improvement in AP-003 treated patients compared to placebo. |
| Secondary | Improvement in clinical symptoms | Up to day 28 of Phase 2 (Phase 2 is 28 days) | Changes in participant's improvement in clinical symptoms from baseline to Day 5, from baseline to Day 10, and from baseline to Day 28 as measured by a daily symptom diary in AP-003 treated patients compared to placebo. |
| Secondary | Emergency department visits | Up to day 28 of Phase 2 (Phase 2 is 28 days) | The proportion of participants attending an emergency department for COVID-19 by Day 28 in AP-003 treated patients compared to placebo. |
| Secondary | Hospitalizations | Up to day 28 of Phase 2 (Phase 2 is 28 days) | The proportion of participants hospitalized for COVID-19 by Day 28 in AP-003 treated patients compared to placebo. |
| Secondary | Duration of hospitalization | Up to day 28 of Phase 2 (Phase 2 is 28 days) | For hospitalized participants, duration of hospitalization in AP-003 treated patients compared to placebo. |
| Secondary | Time from consent to clinical deterioration | Up to day 28 of Phase 2 (Phase 2 is 28 days) | Time from consent to clinical deterioration defined as requiring or recommended for ventilatory support (continuous positive airway pressure \[CPAP\] or ventilator), shock requiring vasopressor support, and/or heart failure (defined as left ventricular ejection fraction \[LVEF\] \< 30%) in AP-003 treated patients compared to placebo. |
| Secondary | Change in SARS CoV-2 viral load | Up to day 28 of Phase 2 (Phase 2 is 28 days) | SARS CoV-2 viral load by quantitative PCR from baseline to Day 5, from baseline to Day 10, and from baseline to Day 28 in AP-003 treated patients compared to placebo. |
| Secondary | Change in inflammatory parameters | Up to day 28 of Phase 2 (Phase 2 is 28 days) | Changes in D dimer, CRP, Ferritin, Troponin, creatine phosphokinase (CPK), LDH, IL-6 from baseline through Day 28 in AP-003 treated patients compared to placebo. |
| Secondary | Organ failure rate | Up to day 28 of Phase 2 (Phase 2 is 28 days) | Organ failure, any organ, from consent through Day 28 in AP-003 treated patients compared to placebo. |
| Secondary | Death rate | Up to day 28 of Phase 2 (Phase 2 is 28 days) | Death, any cause, from consent through Day 28 in AP-003 treated patients compared to placebo. |
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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