Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities

Study Overview
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Brief Summary
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To evaluate the efficacy of subcutaneous ropeginterferon alfa 2b ( P1101 combined with standard of care (SOC) compared with standard care alone in adult COVID-19 patients with comorbidities.

Detailed Description
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This is a multi-center, open label, control study to evaluate the efficacy and safety of ropeginterferon alfa-2b in the treatment of adult COVID-19 patients with comorbidities. Adult COVID-19 patient with the specific comorbidities and being non-responder to the other anti-SARS-CoV-2 drugs, i.e., remdesivir, nirmatrelvir/ritonavir, and molnupiravir, or the patients who is not suitable to receive the other anti-SARS-CoV-2 drugs by investigator's judgement and has positive result (Ct <30) 14 days after the symptom onset of COVID-19 will be enrolled. The eligible patients will be randomized to receive the ropeginterferon alfa-2b plus SOC (study group) or to receive SOC alone (control group). For study group, a single dose of 250 μg ropeginterferon alfa-2b will be subcutaneous administrated at Day 1 visit. For patients who still have positive result (Ct <30) in SARS-CoV-2 RT-PCR at Day 15 and Day 29, the second dose of ropeginterferon alfa-2b at 350 μg and the third dose at 500 μg will be administered, respectively. For control group, patients will receive the SOC alone. The efficacy and safety of ropeginterferon alfa-2b will be evaluated.

Official Title
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An Open Label, Control Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Ropeginterferon alfa-2b
* Procedure: SOC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Willingness to provide a written ICF before entering the study; 2. Male or non-pregnant female patients, ≥ 18 years of age at the time of enrolment (or other age required by local regulations); 3. Patient with the diagnosis of COVID-19 and with the Ct value <30 in SARS-CoV-2 RT-PCR; 4. Patients with any comorbidity below at screening: Hematologic cancer; Solid tumor that requires chemotherapy or other systemic therapy; Well controlled autoimmune diseases; or any other medical comorbidities that requires immunosuppressive therapy; 5. Non-responder to the treatment of any other anti-SARS-CoV-2 drugs, i.e., remdesivir, nirmatrelvir/ritonavir, and/or molnupiravir; or patients who is not suitable to receive the other anti-SARS-CoV-2 drugs by investigator's judgement and has Ct <30 14 days after the symptom onset of COVID-19. Non-responder is defined as a patient who received remdesivir, nirmatrelvir/ritonavir, and/or molnupiravir but still has Ct <30 14 days after the symptom onset of COVID-19. 6. Agrees to the collection of nasopharyngeal or 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. Chronic kidney disease with eGFR <15 mL/min/1.73 m2; 3. Females who are breast-feeding, lactating, pregnant or intending to become pregnant; 4. Known history of severe allergic or hypersensitivity reactions to the active substance or to any of the excipients of ropeginterferon alfa-2b; 5. 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, e.g., major psychiatric (including but not limited to those with severe depression, severe bipolar disorder, schizophrenia, suicidal ideation or history of suicidal attempt) or poorly controlled autoimmune diseases; 6. Clinically significant medical conditions known to interfere with absorption, distribution, metabolism or excretion of the study drugs; 7. Patients treated by monotherapy of telbivudine or any other combination therapy with telbivudine within 1 month prior to screening; 8. Use of an investigational medical product within 1 month prior to screening.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Treated with P1101 (Ropeginterferon alfa-2b) plus standard of care (SOC) | Drug: Ropeginterferon alfa-2b<br>* A maximum of 3 doses of ropeginterferon alfa-2b will be given biweekly during the whole study period. A single dose of 250 μg ropeginterferon alfa-2b will be subcutaneous administrated at Day 1 visit. SARS-CoV-2 antigen test will be conducted at D15 and D29 visits. For patients who still have positive result in SARS-CoV-2 antigen test at Day 15 visit, the second dose of ropeginterferon alfa-2b at 350 μg will be subsequently administered at Day 15 visit. For patients who still have positive result in SARS-CoV-2 antigen test at Day 29 visit, the third dose of ropeginterferon alfa-2b at 500 μg will be administered at Day 29 visit.<br>* Other names: P1101;Procedure: SOC<br>* SOC includes infection prevention and control measures, supportive care, dexamethasone, and antiviral agents. The SOC is based on the Taiwan Centers for Disease Control (CDC) guidance and investigator's discretion.<br>|
| Active Comparator: Control Group<br>Treated with SOC alone | Procedure: SOC<br>* SOC includes infection prevention and control measures, supportive care, dexamethasone, and antiviral agents. The SOC is based on the Taiwan Centers for Disease Control (CDC) guidance and investigator's discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from randomization to the achievement of Ct value ≥30 in SARS-CoV-2 quantitative reverse transcriptase polymerase chain reaction (RT-PCR) | To compare the time from randomization to the achievement of Ct value ≥30 in SARS-CoV-2 quantitative RT-PCR between the Study and Control groups | Up to Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who achieve Ct value ≥30 in quantitative SARS-CoV-2 RT-PCR at Day 15, Day 29, and Day 43 | The proportion of patients who achieve Ct value ≥30 in quantitative SARS-CoV-2 RT-PCR at Day 15, 29, and 43, compared between the Study and Control groups | Up to Day 43 | 
| Change from randomization in the clinical status | The change from randomization in the clinical status of patient on WHO clinical progression scale at Day 15, 29, and 43, compared between the Study and Control groups | Up to Day 43 | 
| Change of SpO2 | The change of SpO2 from randomization to Day 15, 29, and 43, compared between the Study and Control groups | Up to Day 43 | 
| The occurrence and the accumulated duration (days) of supple-mental oxygen | To compare the occurrence and the accumulated duration (days) of supplemental oxygen between the Study and Control groups | Up to Day 57 | 
| The occurrence and the accumulated duration (days) of mechanical ventilation | To compare the occurrence and the accumulated duration (days) of mechanical ventilation between the Study and Control groups | Up to Day 57 |