NCT04321174Unknown3 期
COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 123
- 试验地点
- 4
- 主要终点
- Microbiologic evidence of infection
研究概览
简要总结
COVID-19 has rapidly evolved into a generalized global pandemic. Post-exposure prophylaxis (PEP) against on COVID-19 was identified as an urgent research priority by the WHO, and lopinavir/ritonavir (LPV/r) is a promising candidate for both COVID-19 treatment and PEP, with a good safety profile and global availability. This is a cluster randomized controlled trial (RCT) of oral LPV/r as PEP against COVID-19, that will address the immediate need for preventive interventions, generate key data on COVID-19 transmission, and serve as a research platform for future vaccines and preventive agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High risk close contact with a confirmed COVID-19 case during their symptomatic period, including one day before symptom onset, within the past 1-7 days. High risk close contact is defined as any of the following exposures without the consistent appropriate use of recommended personal protective equipment:
- •Provided direct care for the index case
- •Had close physical contact with the index case
- •Lived with the index case
- •Had close contact (within 2 metres), without direct physical contact, for a prolonged period of time
- •Had direct contact with infectious body fluids, including oral secretions, respiratory secretions, or stool.
- •Successfully contacted by the study team within 24 hours of study team notification of the relevant index COVID-19 case. This time window is necessary because the efficacy of PEP may be dependent on the timing of its initiation, and because randomization of a ring cannot be delayed while awaiting response from contacts that cannot be rapidly reached.
- •Age ≥6 months, since the safety and pharmacokinetic profiles of LPV/r in pediatric patients below the age of 6 months have not been established.
- •Ability to communicate with study staff in English
排除标准
- •Known hypersensitivity/allergy to lopinavir or ritonavir.
- •Current use of LPV/r for the treatment or prevention of HIV infection.
- •Receipt of LPV/r in the context of this trial or any other trial of COVID-19 PEP within 2 days or less prior to the last known contact with the index COVID-19 case. The two day time window is intended to ensure that exposure would not have occurred in the presence of clinically relevant drug levels (five times the elimination half-life of LPV/r, which is estimated at 4-6 hours with prolonged use).
- •Baseline respiratory tract specimen positive for COVID-
- •Randomized participants whose baseline samples subsequently show COVID-19 will have study drug discontinued but still remain under observation.
- •Current breastfeeding, due to potential for serious adverse reactions in nursing infants exposed to LPV/r
- •Concomitant medications with prohibited drug interactions with LPV/r that cannot be temporarily suspended/replaced, including but not restricted to: 37
- •alfuzosin (e.g. Xatral®)
- •amiodarone (e.g. Cordarone™)
- •apalutamide (e.g. Erleada™)
- •astemizole*, terfenadine*
- •cisapride*
- •colchicine, when used in patients with renal and/or hepatic impairment
- •dronedarone (e.g., Multaq®)
- •elbasvir/grazoprevir (e.g., ZepatierTM)
- •ergotamine* (e.g. Cafergot®*), dihydroergotamine (e.g. Migranal®), ergonovine, methylergonovine*
- •fusidic acid (e.g., Fucidin®), systemic*
- •lurasidone (e.g., Latuda®), pimozide (e.g., Orap®*)
- •neratinib (e.g., Nerlynx®)
- •sildenafil (e.g., Revatio®)
- •triazolam (e.g. Halcion®), midazolam oral*
- •rifampin (e.g. Rimactane®*, Rifadin®, Rifater®*, Rifamate®*)
- •St. John's Wort
- •Tadalafil (e.g. Adcirca®)
- •venetoclax (e.g. Venclexta®)
- •lovastatin (e.g., Mevacor®*), lomitapide (e.g., JuxtapidTM) or simvastatin (e.g., Zocor®)
- •vardenafil (e.g., Levitra® or Staxyn®)
- •salmeterol (e.g., Advair® or Serevent®)
- •denotes products not marketed in Canada
研究组 & 干预措施
Lopinavir/ritonavir
Experimental
This arm will receive oral lopinavir/ritonavir 400/100 mg (or equivalent weight-based dosing) twice daily for 14 days.
干预措施: Lopinavir/ritonavir (Drug)
结局指标
主要结局
Microbiologic evidence of infection
时间窗: 14 days
The primary outcome is microbiologically confirmed COVID-19 infection, ie. detection of viral RNA in a respiratory specimen (mid-turbinate swab, nasopharyngeal swab, sputum specimen, saliva specimen, oral swab, endotracheal aspirate, bronchoalveolar lavage specimen) by day 14 of the study.
次要结局
- Symptomatic COVID-19 disease(14 days)
- Seropositivity(28 days)
- Adverse events(90 days)
- Days of hospitalization attributable to COVID-19 disease(90 days)
- Respiratory failure requiring ventilatory support attributable to COVID-19 disease(90 days)
- Mortality(90 days)
- Short-term psychological impact of exposure to COVID-19 disease(28 days)
- Long-term psychological impact of exposure to COVID-19 disease(90 days)
- Health-related quality of life(90 days)
研究者
研究点 (4)
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