PAxlovid loNg cOvid-19 pRevention triAl With recruitMent In the Community in Norway
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Symptoms of long-COVID
研究概览
简要总结
The goal of this clinical trial is to compare treatment with oral Paxlovid (nirmatrelvir/ritonavir) and placebo for acute COVID-19 as an intervention to prevent long-COVID (post-COVID-19 condition) in adults aged 18-64 years old.
The main question it aims to answer is:
Does treatment with Paxlovid for acute COVID-19 reduce the prevalence of long-COVID compared to placebo.
Participants with acute COVID-19, documented with positive lateral flow test or PCR, within the last 5 days will be randomised to take either Paxlovid or placebo. All participants will receive standard of care in addition. Participants will respond to electronic questionnaires at 14 time points during follow-up. The primary outcome is presence of long-COVID symptoms at 3 months follow-up.
Researchers will compare participants who received Paxlovid and placebo to see if Paxlovid treatment can prevent the occurrence of long-COVID.
详细描述
PAxlovid loNg cOvid-19 pRevention triAl with recruitMent In the Community in Norway
Background: Despite high uptake of vaccination against COVID-19, the disease remains prevalent in Norway and in many countries around the world, with many patients continuing to experience considerable morbidity and requiring hospital treatment. There is therefore an urgent need to identify treatments for COVID-19 for use in the community early on in the illness that speeds recovery and prevents the need for hospital admission. A considerable burden of long term complications has been reported after COVID (named long COVID) even after home isolation of mild cases, but are particularly associated with more severe disease, and an early therapeutic intervention could potentially also prevent this COVID-19 related morbidity.
Aims and objectives: The study hypothesis is that antiviral treatment for acute Covid can prevent occurrence of persisting symptoms at 3 months and beyond. The primary objective is to assess whether a 5-day course of nirmatrelvir/ritonavir (Paxlovid ®) treatment for patients with acute Covid verified by positive SARS-CoV-2 PCR test result or positive lateral flow test, can reduce the prevalence of persistent symptoms at 3 months compared to placebo. The overall aim of the research is to identify a tool to prevent long COVID, and reduce its burden on society.
Interventions: This is a randomized clinical trial assessing whether healthy adults (P) treated with Paxlovid (I) for acute Covid versus those treated with placebo (C) will have reduced probability of suffering persistent symptoms at 3 months and beyond (O). Participants will be randomized 1:1 to two arms of the trial. Participants in the intervention arm will receive a standard 5-day treatment course Paxlovid (nirmatrelvir plus ritonavir) in addition to standard of care. Participants in the control arm will receive a 5-day course of placebo tablets, with the same appearance and quantity, in addition to standard of care. Participants will be randomised to receive either the antiviral agent Paxlovid (nirmatrelvir plus ritonavir) in addition to standard of care or Placebo plus standard of care.
Eligibility: Participants who meet the following inclusion criteria may be eligible to take part in the trial:
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms attributable to COVID-19 started within the past 5 days and ongoing
- •Positive PCR or lateral flow SARS-CoV-2 test. Any positive PCR test or a lateral flow test taken between two days before symptom onset and randomisation qualifies.
- •Age between 18 and 65 years
- •Participant is able and willing to provide informed consent
- •Willingness to take a pregnancy test prior to starting study treatment (Participants of childbearing potential)
排除标准
- •Patients that are not able to comply with all study visits
- •Patient currently inpatient at hospital
- •Comorbidity which requires active antiviral treatment as judged by the investigator
- •Any chronic renal impairment
- •Any chronic liver disease or liver impairment
- •Previous randomisation in the PANORAMIC Norway trial
- •Currently participating in a clinical trial of a therapeutic agent
- •Currently taking Paxlovid
- •Known allergy to Paxlovid
- •Use of concomitant medication contraindicated for the treatment of Paxlovid*
- •Pregnant and lactating women
- •Participants of childbearing potential (participants who are anatomically and physiologically capable of becoming pregnant), or have a partner of childbearing potential, not willing to use highly effective contraceptive until 7 days after completing Paxlovid.
- •* Concomitant medications that are contraindicated for the treatment of Paxlovid
- •Medicinal products that are highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions.
- •Medicinal products that are potent CYP3A inducers where significantly reduced nirmatrelvir/ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. Paxlovid cannot be started immediately after discontinuation of such medicinal products due to the delayed offset of the recently discontinued CYP3A inducer.
- •More information is available in the study protocol on medicinal products that are contraindicated with concomitant use of Paxlovid.
研究组 & 干预措施
Nirmatrelvir-ritonavir
Participants will receive a standard 5-day treatment course nirmatrelvir plus ritonavir in addition to standard of care. The participants will receive 2 tablets nirmatrelvir 150 mg twice daily and 1 tablet ritonavir 100mg twice daily, both for a duration of 5 days. The tablets have been encapsulated to maintain blinding.
干预措施: Nirmatrelvir/ritonavir (Drug)
Placebo
Participants in the control arm will receive a 5-day course of placebo tablets in addition to standard of care. The participants will receive 3 tablets twice daily for 5 days. The placebo tablets have the same shape and appearance as the active comparator product. The tablets containing placebo and active comparato have both been encapsulated in the same way to maintain blinding.
干预措施: Placebo (Drug)
结局指标
主要结局
Symptoms of long-COVID
时间窗: Change in symptoms from baseline to 3, 6 and 12 months follow-up
a dichotomous variable for presence of any of the three most important long-COVID symptoms: (i) fatigue, (ii) dyspnea and (iii) cognitive symptoms (defined as memory and/or concentration problems).
次要结局
- Symptoms individually and grouped by organ system(Change in symptoms from baseline to 3, 6, 12 and 24 months follow-up)
- Absence from work(Up to 24 months)
- Symptoms of long-COVID(Change in symptoms from baseline to 3, 6 and 12 months follow-up)
- Hospitalisation(28 days)
- Societal costs(Up to 24 months)
- Graded responses for symptoms and symptom constellations(Change in symptoms from baseline to 3, 6, 12 and 24 months follow-up)
- Risk factors for long-COVID(Up to 24 months)
- Severity of acute disease(28 days)
- Severe adverse events(Up to 24 months)