To evaluate the efficacy of subcutaneous ropeginterferon alfa 2b ( P1101 combined withstandard of care (SOC) compared with standard care alone in adult COVID-19 patients withcomorbidities.
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.
Drug: Ropeginterferon alfa-2b
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.
Other Name: P1101
Procedure: SOC
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.
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:
1. Hematologic cancer;
2. Solid tumor that requires chemotherapy or other systemic therapy;
3. 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.
National Taiwan University Hospital
Taipei, Taiwan
Investigator: Wang-Huei Sheng, professor
Contact: 02-23123456
whsheng@ntu.edu.tw
Wang-Huei Sheng, M.D. Ph.D
886-2-23123456 - 67736
whsheng@ntu.edu.tw
Wang-Huei Sheng, M.D. Ph.D, Principal Investigator
Center of Infection Control of National University Hospital