tetano
Editor, Senior Moderator
Adv Ther
. 2023 Nov 27.
doi: 10.1007/s12325-023-02715-7. Online ahead of print. Study Protocol of a Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in COVID-19 Patients with Comorbidities
Wang-Da Liu[SUP] 1 2 [/SUP], Hsin-An Hou[SUP] 3 [/SUP], Ko-Jen Li[SUP] 4 [/SUP], Albert Qin[SUP] 5 [/SUP], Chan-Yen Tsai[SUP] 5 [/SUP], Wang-Huei Sheng[SUP] 6 7 8 [/SUP]
Affiliations
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).
Keywords: Anti-SARS-CoV-2 drugs; Anti-SARS-CoV-2 efficacy; COVID-19; Patients with comorbidities; Randomized clinical trial; Ropeginterferon alfa-2b.
. 2023 Nov 27.
doi: 10.1007/s12325-023-02715-7. Online ahead of print. Study Protocol of a Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in COVID-19 Patients with Comorbidities
Wang-Da Liu[SUP] 1 2 [/SUP], Hsin-An Hou[SUP] 3 [/SUP], Ko-Jen Li[SUP] 4 [/SUP], Albert Qin[SUP] 5 [/SUP], Chan-Yen Tsai[SUP] 5 [/SUP], Wang-Huei Sheng[SUP] 6 7 8 [/SUP]
Affiliations
- PMID: 38010606
- DOI: 10.1007/s12325-023-02715-7
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).
Keywords: Anti-SARS-CoV-2 drugs; Anti-SARS-CoV-2 efficacy; COVID-19; Patients with comorbidities; Randomized clinical trial; Ropeginterferon alfa-2b.