Single-Blind Study of STAT-205 in Mild COVID-19 : Randomized, Single-Blind Study to Evaluate the Pharmacokinetics, Biomarkers, Safety and Tolerability of STAT-205 in Adult Patients With Mild COVID 19 Who Are at High Risk of Disease Progression
Eligible patients will be randomized, 1:2, to either placebo or STAT-205. Randomization will be stratified by site. STAT-205 treatment will include an initial 5-day dosing period (period 1) of 22.5 mg QD, to be followed by a second dosing period (period 2) of 4.5 mg QD to complete 30 days of dosing. Patients randomized to placebo will receive placebo QD. Blood samples for pharmacokinetic analysis and measurement of inflammatory biomarkers will be collected from patients on day 1, day 6, day 15 and day 30. Patients will be seen in the clinic on days 1, 6, 15, and 30. Patients will be contacted via telephone for follow up on day 60 and on. each post treatment day through Day 60. The telephone visit should occur at approximately the same time each day. During the telephone visits, the presence and severity of COVID-19 symptoms that were recorded at Baseline will be queried, and any new symptoms will be recorded. During the daily telephone visits, patients will also be queried for any adverse events..
| Medienart: |
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Klinische Studie| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
ClinicalTrials.gov - (2021) vom: 22. Dez. Zur Gesamtaufnahme - year:2021 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: January 13, 2021, Last downloaded: ClinicalTrials.gov processed this data on January 03, 2022, Last updated: January 05, 2022 |
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| Study ID: |
NCT04708327 |
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| Veröffentlichungen zur Studie: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG003637611 |
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| 245 | 1 | 0 | |a Single-Blind Study of STAT-205 in Mild COVID-19 |b Randomized, Single-Blind Study to Evaluate the Pharmacokinetics, Biomarkers, Safety and Tolerability of STAT-205 in Adult Patients With Mild COVID 19 Who Are at High Risk of Disease Progression |
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| 520 | |a Eligible patients will be randomized, 1:2, to either placebo or STAT-205. Randomization will be stratified by site. STAT-205 treatment will include an initial 5-day dosing period (period 1) of 22.5 mg QD, to be followed by a second dosing period (period 2) of 4.5 mg QD to complete 30 days of dosing. Patients randomized to placebo will receive placebo QD. Blood samples for pharmacokinetic analysis and measurement of inflammatory biomarkers will be collected from patients on day 1, day 6, day 15 and day 30. Patients will be seen in the clinic on days 1, 6, 15, and 30. Patients will be contacted via telephone for follow up on day 60 and on. each post treatment day through Day 60. The telephone visit should occur at approximately the same time each day. During the telephone visits, the presence and severity of COVID-19 symptoms that were recorded at Baseline will be queried, and any new symptoms will be recorded. During the daily telephone visits, patients will also be queried for any adverse events. | ||
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| 650 | 4 | |a Medical Condition: COVID-19 | |
| 650 | 4 | |a Study Type: Interventional | |
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| 650 | 4 | |a Phase: Phase 1 | |
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