Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19 (NOVATION-1)

Tahapan Penelitian : Awal
Mitra Pelaksana:
RSUP Dr. Sardjito; RSUP Dr. M Djamil; RS Royal Taruma
No Registry
Tanggal Input Registry : 11-07-2022

Rate of clinical deterioration [ Time Frame: From enrollment to Day 28 ]. Proportion of patients requiring mechanical ventilation or that die (defined as WHO categories 6, 7, or 8)
1. Rate of recovery [ Time Frame: From enrollment to Day 28 ]. Proportion of patients demonstrating clinical improvement (defined as WHO categories 0, 1, 2, or 3) 2. Hospital discharge rate [ Time Frame: At Day 28 ]. Rate of non-hospitalized alive patients 3. Mortality rate [ Time Frame: At Day 28 ]. Mortality rate 4. Duration of hospitalization [ Time Frame: Up to Day 28 ]. Number of days hospitalized 5. Adverse events [ Time Frame: From first dose to Day 56 ]. Adverse event incidence, type and severity
Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19 (NOVATION-1)
NOVATION-1: A Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate the Safety and Efficacy of Aerosolized Novaferon + SOC vs. Placebo + SOC in Hospitalized Adult Patients with Moderate to Severe COVID-19
The selected dose regimen is 20 μg aerosolized Novaferon or placebo, administered using a vibrating mesh nebulizer, twice per day with an interval between doses of at least 4 hours, for 10 days, or until discharged, if discharge occurs within 10 days. Each 20 μg dose of Novaferon (2 x 1 mL vials) or placebo will be administered to patients by nebulizer for approximately 10 minutes. The supplied matching placebo formulation is identical in physical appearance to the active formulation and contains the same inactive ingredients. The study treatment/placebo will be given in conjunction with SOC treatment(s)

Inclusion Criteria:

1. Signed informed consent form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures. 2. Men and women, ≥18 years of age at time of enrollment. 3. Laboratory-confirmed diagnosis of SARS-CoV-2 infection as determined by PCR, or other health authority-approved commercial assay or other validated public health assay in any specimen within 72 hours prior to randomization (point-of-care viral infection test allowable if RT-PCR test result not available only at the time of screening). 4. Less than or equal to 9 days from COVID-19 symptom onset to starting treatment. • Symptoms are defined as one or more of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny nose/congestion, loss of taste or smell, or any other COVID-19 symptoms as determined by the Investigator. 5. Hospitalized and i) requiring supplemental oxygen by face mask or nasal prongs, or ii) non-invasive ventilation or iii) high-flow oxygen (WHO category 4 or 5) 6. Female patients participating in this study must agree to avoid becoming pregnant and have a negative pregnancy test prior to randomization. Male and female patients of reproductive potential must use a highly effective, protocol-specified method of contraception during the study and up to post 30 days after the last dose of study drug. For a list of protocol-specified contraceptive methods, and the definition of reproductive potential.

Exclusion Criteria:

1. Known hypersensitivity or intolerance to Interferon (IFN) or Novaferon or any excipient(s) of Novaferon, including pre-existing allergy or hypersensitivity to ampicillin. 2. Currently undergoing invasive mechanical ventilation (including venous ECMO). 3. Inability to use a nebulizer with a mouthpiece. 4. ALT/AST > 5 times the Upper Limit of Normal (ULN) or a history of decompensated cirrhosis. 5. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min/ 1.73m2). 6. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. 7. In the opinion of the Investigator, progression to mechanical ventilation is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. 8. Possibility of the patient being discharged from hospital within 24 hours. 9. Concurrent participation in other anti-COVID-19 therapeutic or interventional trials. Patients may, at the discretion of the Investigator, concurrently participate in other non-interventional COVID-19 studies. 10. Prior or concurrent use of experimental antiviral therapy for COVID-19. 11. Prior or concurrent use of any interferons other than the investigational product 12. Other known active infections or other clinical conditions (e.g., severe chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation. 13. Patients with current or prior psychiatric illness, seizure disorders, retinal autoimmune disorders, pre-existing severe cardiovascular disease, or patients with prior transplants. 14. Females who are breast-feeding, lactating, pregnant or intending to become pregnant. 15. The subject has any medical condition that in the opinion of the investigator would compromise subject's safety or compliance with study procedures.
1) KE/FK/0494/EC/2021, tanggal 18 May 2021; 2) ND-465/UN2.F1/ETIK/PPM.00.02/2021, tanggal 21 Jun 2021; 3) ND-946/ UN2.F1/ ETIK/ PPM.00.02/2021, tanggal 08 Nov 2021
HK.07.02/I/3965/2022, tanggal 30 Juni 2022
1). No. RG., tanggal 30 Agustus 2021; 2). No. B-RG., tanggal 30 Desember 2021
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