NCT04669015Unknown3 期
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
适应症
试验速览
- 阶段
- 3 期
- 发起方
- Genova Inc.
- 入组人数
- 914
- 试验地点
- 89
- 主要终点
- Rate of clinical deterioration
研究概览
简要总结
This study is a randomized, double-blind, multicenter, placebo-controlled trial to evaluate the safety and efficacy of a novel therapeutic agent, Novaferon, in hospitalized adult patients diagnosed with COVID-19. The study is comprised of two cohorts:
- Cohort A: This is a blinded safety lead-in comprising two arms. 40 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus Standard of Care (SOC)
- Cohort B: This is the main portion of the study, which comprises two arms. Up to 874 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus SOC
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •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.
- •Men and women, ≥18 years of age at time of enrollment.
- •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).
- •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.
- •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)
- •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, refer to Appendix 1.
排除标准
- •Exclusion Criteria:
- •Known hypersensitivity or intolerance to Interferon (IFN) or Novaferon or any excipient(s) of Novaferon, including pre-existing allergy or hypersensitivity to ampicillin.
- •Currently undergoing invasive mechanical ventilation (including venous ECMO).
- •Inability to use a nebulizer with a mouthpiece.
- •ALT/AST > 5 times the Upper Limit of Normal (ULN) or a history of decompensated cirrhosis.
- •Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min/ 1.73m2).
- •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.
- •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.
- •Possibility of the patient being discharged from hospital within 24 hours.
- •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.
- •Prior or concurrent use of experimental antiviral therapy for COVID-19 (see Appendix
- •Prior or concurrent use of any interferons other than the investigational product (see Appendix 2)
- •Other known active infections or other clinical conditions (e.g., severe chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation.
- •Patients with current or prior psychiatric illness, seizure disorders, retinal autoimmune disorders, pre-existing severe cardiovascular disease, or patients with prior transplants.
- •Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
- •The subject has any medical condition that in the opinion of the investigator would compromise subject's safety or compliance with study procedures.
结局指标
主要结局
Rate of clinical deterioration
时间窗: From enrollment to Day 28
Proportion of patients requiring mechanical ventilation or that die (defined as WHO categories 6, 7, or 8)
次要结局
- Mortality rate(At Day 28)
- Duration of hospitalization(Up to Day 28)
- Rate of recovery(From enrollment to Day 28)
- Hospital discharge rate(At Day 28)
- Adverse events(From first dose to Day 56)
研究者
研究点 (89)
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