2023-510337-29-00招募中3 期
Paxlovid long covid-19 prevention trial with recruitment in the community in Norway
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 3
- 主要终点
- Continued symptoms of acute COVID-19 and new symptoms according to long-COVID illness.
研究概览
简要总结
The primary objective is to invesigate if early treatment with Paxlovid (nirmatrelvir plus ritonavir) for patients with acute COVID (confirmed PCR or lateral flow test) can reduce long term complications (long COVID)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Follow up phase
- 盲法
- Double (Subject, Investigator, Monitor, Analyst, Carer)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 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 provide informed consent or comply with all study visits.
- •Use of concomitant medication contraindicated for the treatment of Paxlovid.
- •Pregnant and lactating woman.
- •Participants of childbearing potential (participants who are anatomically and psysiologically capable of becoming pregnant), or have a partner of childbearing potential, not willing to use highly effective contraceptive until 7 days after completing Paxlovid.
- •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.
结局指标
主要结局
Continued symptoms of acute COVID-19 and new symptoms according to long-COVID illness.
Continued symptoms of acute COVID-19 and new symptoms according to long-COVID illness.
次要结局
- A cause, non-elective hospitalisation and/or death, within 28 days of randomisation.
- Participant reported symptoms daily for 7 days, weekly for 28 days and at 3 and 6 months.
- Contacts with health services reported by paticipants and/or captured by review for health registries.
- New infections in the household reported by the participants.
- Evaluation of overall safety of drugs by the monitoring of adverse events (AEs as defined in the ISAs).
- Well-being, symptoms and health care utilisation.
- Resource use and cost data.
研究者
Nina Langeland
Scientific
Helse Bergen HF
研究点 (3)
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