Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Moderate COVID19. (NCT05770466) | Clinical Trial Compass
CompletedPhase 3
Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Moderate COVID19.
Taiwan134 participantsStarted 2022-04-01
Plain-language summary
To evaluate the efficacy of subcutaneous ropeginterferon alfa 2b ( P1101combined with standard of care (SOC) compared with standard care alone in hospitalized adults with moderate COVID 19.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability to comprehend and willingness to provide a written ICF before enter the study;
. Male or non-pregnant female patients, ≥ 20 years of age at the time of enrolment;
. Hospitalized patient with a diagnosis of COVID-19 on the basis of a positive# reverse transcriptase polymerase chain reaction (RT-PCR) with moderate## disease on admission###. #: Ct value \<30. ##:Disease severity as defined by the treatment guidance of Taiwan Centers for Disease Control (CDC):
. Agrees to the collection of pharyngeal swabs and blood sample as per protocol.
Exclusion criteria
. Known history or presence of decompensated cirrhosis of the liver (Child-Pugh B or C) before study entry.
. Patients with intubation, respiratory failure, septic shock, multiple organ dysfunction or need additional organ support (e.g. vasopressors or ECMO).
. Patients who have SpO2 \<93% on room air, respiratory frequency \>30 breaths/min.
. Patients treated by dexamethasone before Day 1.
. Patients treated by supplemental oxygen (FiO2 \>40%) before Day 1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients who are negative to SARS-CoV-2 at Day 8
. Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \<15 mL/min/1.73 m2).
. Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
. Known history of severe allergic or hypersensitivity reactions, e.g. hypersensitivity to the active substance or to any of the excipients of ropeginterferon alfa-2b.