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Posted On: 06/03/2021 8:59:05 AM
Post# of 72440
https://clinicaltrials.gov/ct2/show/study/NCT...amp;rank=2
his Phase 2 study is a randomized, blinded, placebo-controlled, parallel group design.
The target population to be treated are patients with moderate to severe COVID-19, SARS-CoV-2 infection confirmed by positive standard polymerase chain reaction (PCR) test (or equivalent/ other approved diagnostic test) within 4 days prior to starting study treatment, and hospitalized with respiratory distress but not yet requiring high-level respiratory support (as defined in exclusion criterion #2). See inclusion/exclusion criteria.
The study is comprised of three parts:
Screening/ Baseline visit (Day -1 to 1): Lasts up to 24-48 hours and comprises screening/ baseline assessments. This visit will confirm that study inclusion and exclusion criteria are met by participants prior to randomization.
Treatment period (Day 1-3 with potential to expand to Day 4-5): Randomized subjects will receive blinded study treatment once daily for 3 days by IV infusion, in addition to SoC.
Follow-up period (Day 4-6 through Day 60): Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 15 and 29. A follow-up visit at Day 60(±10), by telephone call, is also included to confirm patient status.
All subjects will undergo a series of efficacy and safety assessments, including laboratory assays. Additional blood samples and nasopharyngeal (NP) swabs will also be obtained (oropharyngeal (OP) swabs to be collected only in exceptional circumstances).
The study started with 3 days of study drug administration. After an interim analysis safety review, by an independent Data Monitoring Committee (DMC), dosing has since been extended to 5 days.
his Phase 2 study is a randomized, blinded, placebo-controlled, parallel group design.
The target population to be treated are patients with moderate to severe COVID-19, SARS-CoV-2 infection confirmed by positive standard polymerase chain reaction (PCR) test (or equivalent/ other approved diagnostic test) within 4 days prior to starting study treatment, and hospitalized with respiratory distress but not yet requiring high-level respiratory support (as defined in exclusion criterion #2). See inclusion/exclusion criteria.
The study is comprised of three parts:
Screening/ Baseline visit (Day -1 to 1): Lasts up to 24-48 hours and comprises screening/ baseline assessments. This visit will confirm that study inclusion and exclusion criteria are met by participants prior to randomization.
Treatment period (Day 1-3 with potential to expand to Day 4-5): Randomized subjects will receive blinded study treatment once daily for 3 days by IV infusion, in addition to SoC.
Follow-up period (Day 4-6 through Day 60): Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 15 and 29. A follow-up visit at Day 60(±10), by telephone call, is also included to confirm patient status.
All subjects will undergo a series of efficacy and safety assessments, including laboratory assays. Additional blood samples and nasopharyngeal (NP) swabs will also be obtained (oropharyngeal (OP) swabs to be collected only in exceptional circumstances).
The study started with 3 days of study drug administration. After an interim analysis safety review, by an independent Data Monitoring Committee (DMC), dosing has since been extended to 5 days.
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