NCT04439071终止2 期
Evaluation of the Efficacy and Safety of PTC299 in Hospitalized Subjects With COVID-19 (FITE19)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 189
- 试验地点
- 41
- 主要终点
- Time From Randomization to Respiratory Improvement
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multicenter, 28-day study of adult participants hospitalized with COVID-19, with a safety follow-up telephone call at Day 60.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed and dated informed consent document(s).
- •Agrees to the collection of nasopharyngeal swabs and venous blood and all other protocol-specified procedures.
- •Male or non-pregnant female adult ≥18 years of age at time of enrollment.
- •Hospitalized and has laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- •Symptom onset was ≤10 days prior to screening.
- •Has oxygen saturation SpO2 <94% on room air.
- •Has at least one of a respiratory rate >24 breaths/minute or cough.
- •Lung involvement as confirmed by radiographic infiltrates observed on imaging (chest X-ray, computed tomography (CT) scan, or an equivalent test).
- •Women of childbearing potential (as defined in [CTFG 2014]) must have a negative pregnancy test at screening and agree to abstinence or the use at least one of the following highly effective forms of contraception (with a failure rate of <1% per year when used consistently and correctly). Contraception or abstinence must be continued for the duration of the study following discharge from the hospital, and for up to 50 days after the last dose of study drug:
- •i) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, and transdermal ii) progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, and implantable iii) intrauterine device iv) intrauterine hormone-releasing system v) vasectomized partner with confirmed azoospermia All females will be considered of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea in the appropriate age group without other known or suspected cause) or have been sterilized surgically (for example, bilateral tubal ligation, hysterectomy, bilateral oophorectomy).
- •Men sexually active with women of childbearing potential who have not had a vasectomy must agree to use a barrier method of birth control during the study following discharge from the hospital and for up to 50 days after the last dose of study drug.
排除标准
- •Requires mechanical ventilation.
- •Current participation in any other interventional study.
- •Alanine transaminase/aspartate transaminase levels ≥3 times the upper limit of normal (×ULN) or total bilirubin (Tbili) ≥2×ULN.
- •Lymphocyte count <500 lymphocytes/microliter (μL) or hemoglobin <11 grams/deciliter (g/dL).
- •Stage 4 severe chronic kidney disease or requiring dialysis (that is, estimated glomerular filtration rate <30).
- •Any other condition, that in the opinion of the Investigator, may be cause to exclude the participant from the study.
- •Use of steroids (except dexamethasone), sensitive CYP2D6 substrates, CYP2C inducers, IL-6 neutralizing antibodies, IL-6 receptor inhibitors, or any investigational therapy.
- •Pregnancy or breast feeding.
- •Anticipated transfer to another hospital which is not a study site within 72 hours.
- •Known allergy to PTC299 or excipients.
研究组 & 干预措施
Placebo + SOC
Placebo Comparator
Participants will receive PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.
SOC will also be administered according to local, written policies or guidelines.
干预措施: SOC (Other)
PTC299 + Standard of Care (SOC)
Experimental
Participants will receive PTC299 at 200 milligrams (mg), administered orally, twice daily (BID) on Days 1 to 7, then at 50 mg administered orally, once daily (QD) on Days 8 to 14.
SOC will also be administered according to local, written policies or guidelines.
干预措施: PTC299 (Drug)
PTC299 + Standard of Care (SOC)
Experimental
Participants will receive PTC299 at 200 milligrams (mg), administered orally, twice daily (BID) on Days 1 to 7, then at 50 mg administered orally, once daily (QD) on Days 8 to 14.
SOC will also be administered according to local, written policies or guidelines.
干预措施: SOC (Other)
Placebo + SOC
Placebo Comparator
Participants will receive PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.
SOC will also be administered according to local, written policies or guidelines.
干预措施: Placebo (Drug)
结局指标
主要结局
Time From Randomization to Respiratory Improvement
时间窗: up to Day 28
Respiratory improvement was defined as sustained peripheral oxygen saturation (SpO2) ≥94% on room air. Median time to respiratory improvement was estimated via the Kaplan-Meier product limit method.
次要结局
- Change From Baseline in Viral Load at Day 28: SARS-CoV-2 IgM Antibody Absorbance(Baseline, Day 28)
- Number of Mortalities at Day 28(Day 28)
- Number of Participants Requiring Supplemental Oxygen or Non-Invasive Ventilation in Participants Who Did Not Require Supplemental Oxygen at Baseline(up to Day 28)
- Time From Randomization to Defervescence in Participants Presenting With Fever at Enrollment (Temperature of ≥37.6℃ Axilla, ≥38.0℃ Oral, or ≥38.6°C Tympanic or Rectal)(up to Day 28)
- Change From Baseline in Level of Acute Phase Protein (Ferritin) at Day 28(Baseline, Day 28)
- Change From Baseline in Level of Acute Phase Proteins (Troponin I and Troponin T) at Day 28(Baseline, Day 28)
- Change From Baseline in Viral Load at Day 28: SARS-CoV2 v2, SARS-CoV2 v2 Nasopharyngeal Swab (NPsw), and Severe Acute Resp Syndrome Coronavirus 2(Baseline, Day 28)
- Duration of Hospitalization(up to Day 28)
- Time From Randomization to Dyspnea Reported as Mild or Absent(up to Day 28)
- Number of Participants With Normalization of Complete Blood Count (CBC) Who Had CBC Out of Range at Baseline(up to Day 28)
- Change From Baseline in Viral Load at Day 28: SARS-CoV-2 Immunoglobulin A (IgA) Antibody Ratio and SARS-CoV-2 Immunoglobulin G (IgG) Antibody Ratio(Baseline, Day 28)
- Number of Participants Requiring Invasive Ventilation(up to Day 28)
- Time From Randomization to Respiratory Rate ≤ 24 Breaths Per Minute on Room Air(up to Day 28)
- Change From Baseline in Cytokine Levels at Day 28(Baseline, Day 28)
- Change From Baseline in Level of Acute Phase Protein (C Reactive Protein) at Day 28(Baseline, Day 28)
- Time From Randomization to Cough Reported as Mild or Absent(up to Day 28)
- Change From Baseline in Level of Acute Phase Protein (D-Dimer) at Day 28(Baseline, Day 28)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(up to Day 60)
研究者
研究点 (41)
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