Loading clinical trials...

COMPLETEDPHASE3

Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Moderate COVID19.

A Multicenter, Open-label, Randomized Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in the Treatment of Patients With Moderate COVID-19

NCT05770466•National Taiwan University Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Ability to comprehend and willingness to provide a written ICF before enter the study;
•2. Male or non-pregnant female patients, ≥ 20 years of age at the time of enrolment;
•3. 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):
•\> Moderate: Pneumonia patients without severe symptoms, blood oxygen saturation ≥93% without supplemental oxygen equipment (on room air); ###: Confirmed positive RT-PCR result ≤ 4 days prior to screening visit is eligible
•4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol.

Exclusion Criteria

•1. Known history or presence of decompensated cirrhosis of the liver (Child-Pugh B or C) before study entry.
•2. Patients with intubation, respiratory failure, septic shock, multiple organ dysfunction or need additional organ support (e.g. vasopressors or ECMO).
•3. Patients who have SpO2 \<93% on room air, respiratory frequency \>30 breaths/min.
•4. Patients treated by dexamethasone before Day 1.
•5. Patients treated by supplemental oxygen (FiO2 \>40%) before Day 1.
•6. Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \<15 mL/min/1.73 m2).
•7. Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
•8. 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.
•9. Known history or presence of poorly controlled or clinically significant medical conditions that are not suitable to be enrolled, at the discretion of the investigator: major psychiatric (including but not limited to those with severe depression, severe bipolar disorder, schizophrenia, suicidal ideation or history of suicidal attempt).
•11\. Clinically significant medical conditions known to interfere with absorption, distribution, metabolism or excretion of the study drugs.
+4 more criteria

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Key Dates

Start Date

April 1, 2022

Primary Completion Date

December 21, 2022

Completion Date

January 11, 2023

Last Updated

April 16, 2024

Enrollment

134

ACTUAL participants

Conditions

COVID-19

Interventions

P1101 (Ropeginterferon alfa-2b)

DRUG

SOC

PROCEDURE

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

NCT06082518

Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

View study

RECRUITINGPHASE1

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

NCT07221162

COVID-19

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Moderate COVID19.

Inclusion Criteria

Exclusion Criteria

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

Dime La VerDAD: Verify, Debunk, and Disseminate

Positron Emission Tomography (PET) Imaging of Thrombosis