Study Protocol of a Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in COVID-19 Patients with Comorbidities
© 2023. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature..
INTRODUCTION: Ropeginterferon alfa-2b represents a new-generation PEGylated interferon. It is approved for the treatment of polycythemia vera and shows promising anti-SARS-CoV-2 activities.
OBJECTIVE: This clinical study aims to evaluate the efficacy and safety of ropeginterferon alfa-2b in patients with coronavirus disease 2019 (COVID-19) and comorbidities.
METHODS: The randomized controlled study is designed to enroll adult patients with COVID-19 infection and comorbidities. Patients are non-responders to anti-SARS-CoV-2 drugs or not suitable to receive them. Comorbidities include hematologic cancer, solid tumor, and well-controlled autoimmune disease. Non-responders to anti-SARS-CoV-2 drugs are defined as having received treatment but have a Ct value < 30 at 14 days after symptom onset. Patients are randomized in a 1:1 ratio to receive ropeginterferon alfa-2b at 250 μg plus standard of care (SOC) or SOC alone. SARS-CoV-2 antigen test will be conducted at day 15 and day 29 visits to determine whether to administer additional ropeginterferon alfa-2b doses. Patients who are positive on the antigen test on days 15 and 29 will receive the second and third doses of ropeginterferon alfa-2b at 350 μg and 500 μg, respectively. Patients with a negative antigen test but a Ct value < 30 by reverse transcription polymerase chain reaction (RT-PCR) at days 15 and 29 are also administered the second (350 μg) and third (500 μg) doses. Patients at high risk of COVID-19 rebound/relapse, e.g., immunocompromised patients, will be given additional ropeginterferon alfa-2b doses even if the Ct is ≥ 30. Approximately 60 patients will be enrolled.
PLANNED OUTCOMES: The primary outcome is to compare the time from randomization to the achievement of Ct value ≥ 30 by RT-PCR between ropeginterferon alfa-2b and control groups. Our previous studies have shown safety and promising anti-SARS-CoV-2 activities in patients with moderate or severe COVID-19. This study will provide valuable data in patients with COVID-19 and comorbidities, for whom safe and effective treatment is urgently needed.
TRIAL REGISTRATION NUMBER: This trial is registered at ClinicalTrials.gov (Identifier NCT05808322).
Medienart: |
E-Artikel |
---|
Erscheinungsjahr: |
2024 |
---|---|
Erschienen: |
2024 |
Enthalten in: |
Zur Gesamtaufnahme - volume:41 |
---|---|
Enthalten in: |
Advances in therapy - 41(2024), 2 vom: 27. Feb., Seite 847-856 |
Sprache: |
Englisch |
---|
Beteiligte Personen: |
Liu, Wang-Da [VerfasserIn] |
---|
Links: |
---|
Anmerkungen: |
Date Completed 06.02.2024 Date Revised 14.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT05808322 Citation Status MEDLINE |
---|
doi: |
10.1007/s12325-023-02715-7 |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
NLM365018104 |
---|
LEADER | 01000caa a22002652 4500 | ||
---|---|---|---|
001 | NLM365018104 | ||
003 | DE-627 | ||
005 | 20240314234703.0 | ||
007 | cr uuu---uuuuu | ||
008 | 231226s2024 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1007/s12325-023-02715-7 |2 doi | |
028 | 5 | 2 | |a pubmed24n1328.xml |
035 | |a (DE-627)NLM365018104 | ||
035 | |a (NLM)38010606 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Liu, Wang-Da |e verfasserin |4 aut | |
245 | 1 | 0 | |a Study Protocol of a Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in COVID-19 Patients with Comorbidities |
264 | 1 | |c 2024 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ƒaComputermedien |b c |2 rdamedia | ||
338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Date Completed 06.02.2024 | ||
500 | |a Date Revised 14.03.2024 | ||
500 | |a published: Print-Electronic | ||
500 | |a ClinicalTrials.gov: NCT05808322 | ||
500 | |a Citation Status MEDLINE | ||
520 | |a © 2023. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature. | ||
520 | |a INTRODUCTION: Ropeginterferon alfa-2b represents a new-generation PEGylated interferon. It is approved for the treatment of polycythemia vera and shows promising anti-SARS-CoV-2 activities | ||
520 | |a OBJECTIVE: This clinical study aims to evaluate the efficacy and safety of ropeginterferon alfa-2b in patients with coronavirus disease 2019 (COVID-19) and comorbidities | ||
520 | |a METHODS: The randomized controlled study is designed to enroll adult patients with COVID-19 infection and comorbidities. Patients are non-responders to anti-SARS-CoV-2 drugs or not suitable to receive them. Comorbidities include hematologic cancer, solid tumor, and well-controlled autoimmune disease. Non-responders to anti-SARS-CoV-2 drugs are defined as having received treatment but have a Ct value < 30 at 14 days after symptom onset. Patients are randomized in a 1:1 ratio to receive ropeginterferon alfa-2b at 250 μg plus standard of care (SOC) or SOC alone. SARS-CoV-2 antigen test will be conducted at day 15 and day 29 visits to determine whether to administer additional ropeginterferon alfa-2b doses. Patients who are positive on the antigen test on days 15 and 29 will receive the second and third doses of ropeginterferon alfa-2b at 350 μg and 500 μg, respectively. Patients with a negative antigen test but a Ct value < 30 by reverse transcription polymerase chain reaction (RT-PCR) at days 15 and 29 are also administered the second (350 μg) and third (500 μg) doses. Patients at high risk of COVID-19 rebound/relapse, e.g., immunocompromised patients, will be given additional ropeginterferon alfa-2b doses even if the Ct is ≥ 30. Approximately 60 patients will be enrolled | ||
520 | |a PLANNED OUTCOMES: The primary outcome is to compare the time from randomization to the achievement of Ct value ≥ 30 by RT-PCR between ropeginterferon alfa-2b and control groups. Our previous studies have shown safety and promising anti-SARS-CoV-2 activities in patients with moderate or severe COVID-19. This study will provide valuable data in patients with COVID-19 and comorbidities, for whom safe and effective treatment is urgently needed | ||
520 | |a TRIAL REGISTRATION NUMBER: This trial is registered at ClinicalTrials.gov (Identifier NCT05808322) | ||
650 | 4 | |a Clinical Trial Protocol | |
650 | 4 | |a Journal Article | |
650 | 4 | |a Anti-SARS-CoV-2 drugs | |
650 | 4 | |a Anti-SARS-CoV-2 efficacy | |
650 | 4 | |a COVID-19 | |
650 | 4 | |a Patients with comorbidities | |
650 | 4 | |a Randomized clinical trial | |
650 | 4 | |a Ropeginterferon alfa-2b | |
650 | 7 | |a Polyethylene Glycols |2 NLM | |
650 | 7 | |a 3WJQ0SDW1A |2 NLM | |
700 | 1 | |a Hou, Hsin-An |e verfasserin |4 aut | |
700 | 1 | |a Li, Ko-Jen |e verfasserin |4 aut | |
700 | 1 | |a Qin, Albert |e verfasserin |4 aut | |
700 | 1 | |a Tsai, Chan-Yen |e verfasserin |4 aut | |
700 | 1 | |a Sheng, Wang-Huei |e verfasserin |4 aut | |
773 | 0 | 8 | |i Enthalten in |t Advances in therapy |d 1990 |g 41(2024), 2 vom: 27. Feb., Seite 847-856 |w (DE-627)NLM085859427 |x 1865-8652 |7 nnns |
773 | 1 | 8 | |g volume:41 |g year:2024 |g number:2 |g day:27 |g month:02 |g pages:847-856 |
856 | 4 | 0 | |u http://dx.doi.org/10.1007/s12325-023-02715-7 |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a GBV_NLM | ||
951 | |a AR | ||
952 | |d 41 |j 2024 |e 2 |b 27 |c 02 |h 847-856 |