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

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What is this study about?

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.

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

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

3 Daily monitoring – first week

You will report your symptoms daily for the first 7 days

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

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 Study?

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)
The test must be taken between 2 days before symptoms started and the day of joining the study
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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country	Status
Hagns Bwbnbn Hk	Bergen	Norway
Hnglm Michu Oy Rxyjwuh Hg	Aalesund	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not recruiting	01.04.2023

Trial locations

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.

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.

Trial ID:

2023-510337-29-00

Protocol code:

PANORAMIC-Norway

NCT ID:

NCT05852873

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?