Not recruiting

Study of nirmatrelvir and ritonavir (Paxlovid) for prevention of long COVID-19 in patients with acute COVID-19 infection in Norway

Verified siteRegistered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating COVID-19 and preventing Long COVID, a condition where symptoms persist long after the initial infection. The research examines whether early treatment with a combination of two antiviral medications - nirmatrelvir and ritonavir (together known as Paxlovid) - can help reduce long-term complications in people who have recently tested positive for COVID-19.

The treatment involves taking tablets of nirmatrelvir and ritonavir by mouth for up to 5 days. Some participants will receive the actual medications, while others will receive a placebo. This approach helps determine if the treatment is effective in preventing the development of lasting symptoms.

The study will monitor participants' symptoms and overall health for several months after treatment. This includes tracking any new symptoms that might develop, checking for additional infections, and evaluating the general safety of the medications. The research aims to understand if early treatment with these antiviral medications can prevent the development of long-term COVID-19 complications.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial qualification
You must have COVID-19 symptoms that started within the last 5 days
You need a positive COVID-19 test result (PCR or lateral flow test) taken between two days before symptoms started and the day of joining the study
Your age must be between 18 and 65 years
If you can become pregnant, you will need to take a pregnancy test before starting treatment
Step 2
Treatment phase
You will receive either Paxlovid (containing nirmatrelvir and ritonavir) or a placebo (inactive tablet)
The medication will be taken by mouth
The placebo tablet is white, round, and has markings on one side
Step 3
Daily monitoring - first week
You will report your symptoms daily for the first 7 days
Step 4
Weekly monitoring - first month
You will report your symptoms weekly for 28 days
Any hospital visits or health issues during this time will be recorded
Step 5
Long-term follow-up
You will report your symptoms at 3 months and 6 months after starting the study
The study will monitor your overall health and any ongoing COVID-19 symptoms
Your healthcare service use will be tracked through health registries

Who can join the trial?

6 criteria

Have symptoms of COVID-19 that started within the last 5 days and are still present
Have a positive test result for SARS-CoV-2 (coronavirus) through either:
- A PCR test (laboratory test)
- A lateral flow test (rapid home test)
- Be between 18 and 65 years old
- Be able and willing to give informed consent to participate in the study
- For participants who can become pregnant: Must be willing to take a pregnancy test before starting the study treatment

Who cannot join the trial?

15 criteria

Age below 18 years or above 65 years
Previous treatment with Paxlovid (nirmatrelvir plus ritonavir) in the last 6 months
Known allergy or hypersensitivity to nirmatrelvir or ritonavir
Severe liver problems (as these medications are processed by the liver)
Severe kidney problems (as these medications are filtered by the kidneys)
Currently taking medications that interact with Paxlovid
Pregnancy or breastfeeding
No positive COVID-19 test result (either PCR or lateral flow test)
Symptoms of COVID-19 lasting more than 5 days
Currently participating in another clinical trial
Unable to provide informed consent
History of organ transplantation
Active cancer treatment
HIV infection with uncontrolled viral load
Severe heart conditions

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Helse Bergen HF
Bergen, Norway
Verified
Helse Moere Og Romsdal HF
Aalesund, Norway
Verified
Oslo Universitetssykehus HF
Oslo, Norway

Trial locations

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Investigated drugs

Paxlovid is a combination antiviral medication that contains two active ingredients: nirmatrelvir and ritonavir. It is used to treat COVID-19 infection. Nirmatrelvir works by blocking a key enzyme that the coronavirus needs to multiply, while ritonavir helps keep nirmatrelvir active in the body for longer. The medication is taken by mouth and is used in the early stages of COVID-19 infection to help prevent severe illness and potentially reduce the risk of developing long COVID symptoms.

What is already known about the treatment

Paxlovid
A combination oral antiviral medication containing nirmatrelvir and ritonavir, taken as tablets for the treatment of COVID-19 infection. This medication works by blocking a key enzyme (protease) that the SARS-CoV-2 virus needs to replicate, while ritonavir helps maintain effective levels of nirmatrelvir in the body. Paxlovid belongs to the class of protease inhibitors and is currently authorized for emergency use in treating mild-to-moderate COVID-19 in adults and children who are at high risk for progression to severe disease. Recent clinical trials are investigating its potential role in preventing long COVID symptoms when administered early in the course of acute infection.
Nirmatrelvir
An antiviral medication that serves as the primary active component in Paxlovid, administered orally in tablet form. It functions by specifically targeting and inhibiting the SARS-CoV-2 main protease enzyme, which is essential for viral replication. This medication belongs to the class of viral protease inhibitors and represents one of the first oral treatments specifically designed to combat COVID-19 infection.
Ritonavir
An antiviral medication used as a pharmacokinetic enhancer in the Paxlovid combination, taken orally in tablet form. It works by slowing down the breakdown of nirmatrelvir in the liver, helping to maintain effective therapeutic levels of the primary drug in the body. Originally developed as an HIV protease inhibitor, ritonavir is now commonly used as a booster for other antiviral medications to improve their effectiveness.

Investigated diseases

COVID-19
A viral respiratory illness caused by the SARS-CoV-2 virus that primarily affects the respiratory system. The infection typically begins with symptoms such as fever, cough, and fatigue, which can develop gradually or appear suddenly. The acute phase of the illness usually lasts several days to weeks, during which people may experience various symptoms including loss of taste and smell, body aches, and breathing difficulties. Some individuals may develop longer-lasting symptoms known as long COVID.
Long COVID
A condition characterized by persistent symptoms or new health issues that continue for weeks or months after the initial COVID-19 infection. Common manifestations include ongoing fatigue, breathing problems, brain fog, joint pain, and sleep disturbances. The symptoms can fluctuate over time and vary significantly between individuals. Long COVID can affect multiple organ systems and may develop regardless of the initial infection's severity.