Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04723537
Status:
TERMINATED
Last Update Posted:
2024-06-06
First Post:
2021-01-18
Brief Title:
Upamostat a Serine Protease Inhibitor or Placebo for Treatment of COVID-19 Disease
Sponsor:
RedHill Biopharma Limited
Organization:
RedHill Biopharma Limited
Study Overview
Official Title:
Phase 23 Study of Upamostat a Serine Protease Inhibitor or Placebo for Treatment of COVID-19 Disease
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Part A complete corporate decision made to cancel Part B
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A 2-part multicenter Phase 23 randomized double-blind placebo-controlled parallel group study to evaluate the safety and efficacy of upamostat in adult patients with COVID-19 disease who do not require inpatient care
Detailed Description:
Patients will be seen in a medical facility ER or COVID-19 clinic for initial evaluation Consenting diagnostically-confirmed COVID-19 patients not in need of hospitalization per investigator assessment and who meet all other inclusion and exclusion criteria will be randomized to treatment and provided with medication and home monitoring devices and instructed in drug administration and use of the devices They will take medication daily for two weeks complete a smartphone-based questionnaire provide additional monitoring information via devices provided periodically over an 8-week period Patients will be seen at home by a study nurse or return to the clinic after 2 4 and 8 weeks on study follow up visits additional televisits will also be conducted At the follow up visits nasal swab specimens for COVID-19 PCR and blood specimens for safety labs and disease markers will be collected
In part A of the study patients will be randomized 111 to one of two doses of upamostat or placebo Based on safety results of part A a dose for part B will be selected and patients will be randomized 32 to active vs placebo
In part A of the study patients will be randomized 111 to one of two doses of upamostat or placebo Based on safety results of part A a dose for part B will be selected and patients will be randomized 32 to active vs placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None