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

National Taiwan University

Status and phase: Completed; Phase 3

Conditions: COVID-19

Treatments: Procedure: SOC; Drug: P1101 (Ropeginterferon alfa-2b)

Study type: Interventional

Funder types: Other

Identifiers

NCT05770466

202108013MIPC

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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).

10. Clinically significant medical conditions known to interfere with absorption, distribution, metabolism or excretion of the study drugs.

11. Patients treated by monotherapy of telbivudine or any other combination therapy with telbivudine within 1 month prior to screening.

13.Therapy with any anti-neoplastic, or immunomodulatory treatment within 1 month prior to screening.

14. Patient who have been vaccinated with any live attenuated vaccine or COVID- 19 vaccine within 1 month prior to screening.

15. Use of an investigational medical product within 1 month prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Experimental group

Experimental group

Description:

Treated with P1101 (Ropeginterferon alfa-2b) plus standard of care (SOC)

Treatment:

Procedure: SOC

Drug: P1101 (Ropeginterferon alfa-2b)

Control group

Active Comparator group

Description:

Treated with SOC alone

Treatment:

Procedure: SOC