PACTR202107692340845尚未招募3 期
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
- 状态
- 尚未招募
- 发起方
- Genova Inc.
- 入组人数
- 914
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- All
入选标准
- •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. Diagnosis to be confirmed by RT-PCR test on Day 1).
- •4.Less than or equal to 7 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 for no more than 4 days duration, 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 patients must agree to use appropriate contraceptive methods to prevent pregnancy with their partner(s), during the study and up to post 30 days after the last dose of study drug. Female patients must be:
- •?unable to have children (e.g., post-menopausal*, bilateral tubal ligation, hysterectomy, bilateral oophorectomy) or where the partner is sterile (e.g., vasectomy) OR
- •?willing to remain abstinent (not engage in sexual intercourse for the duration of the screening period and throughout the study, and for 30 days after the last dose) OR
- •?willing to use two approved effective methods of birth control (male partner using condom and female partner using intrauterine device, hormonal or nonhormonal contraceptive, diaphragm plus spermicide, or contraceptive sponge)
- •*Post-menopausal is defined as any female who is: (1) older than 55 years with amenorrhea for at least 12 consecutive months; or (2) less than 55 years with amenorrhea for at least two years
排除标准
- •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.Current use of other antiviral therapy (e.g., remdesivir, etc.) or other experimental therapy, including anti-inflammatory agents, convalescent plasma, ivermectin or hydroxychloroquine (see Section 9.4.1).
- •11.Has received or has a plan to receive within the 28-day treatment period, a SARS- CoV-2 vaccine.
- •12.Use of immunomodulatory drugs at, or within 3 months prior to, enrollment; use of chronic oral corticosteroids for a non-COVID-19-related condition at a dose higher than prednisone 20 mg (or equivalent) per day for the preceding 4 weeks.
- •13.Other known active infections or other clinical conditions (e.g., chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation; coexisting pneumonia is allowed.
- •14.Patients with current or prior psychiatric illness, seizure disorders, retinal autoimmune disorders, pre-existing severe cardiovascular disease, and patients with prior transplants.
- •15.Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
- •16.The subject has Acquired Immunodeficiency Syndrome (AIDS) or hepatitis, including
- •hepatitis virus carriers (HBs-antigen or HCV-antibody-positive). The subject may be included in the study if HCV-antigen or HCV-RNA-negative.
研究者
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