Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05808322
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-11
First Post:
2023-04-09
Brief Title:
Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
An Open Label Control Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the efficacy of subcutaneous ropeginterferon alfa 2b P1101 combined with standard of care SOC compared with standard care alone in adult COVID-19 patients with comorbidities
Detailed Description:
This is a multi-center open label control study to evaluate the efficacy and safety of ropeginterferon alfa-2b in the treatment of adult COVID-19 patients with comorbidities Adult COVID-19 patient with the specific comorbidities and being non-responder to the other anti-SARS-CoV-2 drugs ie remdesivir nirmatrelvirritonavir and molnupiravir or the patients who is not suitable to receive the other anti-SARS-CoV-2 drugs by investigators judgement and has positive result Ct 30 14 days after the symptom onset of COVID-19 will be enrolled The eligible patients will be randomized to receive the ropeginterferon alfa-2b plus SOC study group or to receive SOC alone control group For study group a single dose of 250 μg ropeginterferon alfa-2b will be subcutaneous administrated at Day 1 visit For patients who still have positive result Ct 30 in SARS-CoV-2 RT-PCR at Day 15 and Day 29 the second dose of ropeginterferon alfa-2b at 350 μg and the third dose at 500 μg will be administered respectively For control group patients will receive the SOC alone The efficacy and safety of ropeginterferon alfa-2b will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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