Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A 4-week double-blind, randomized, placebo-controlled, phase II study evaluating the effects of oral pamapimod 150 mg with pioglitazone 10 mg daily on COVID-19 evolution and recovery in non-hospitalized patients infected with SARS-CoV-2 (severe acute respiratory syndrome-coronavirus-2)

This research study is investigating whether combining two existing medications, pamapimod and pioglitazone, can help people with COVID-19 recover more quickly. It's for individuals who have COVID-19 but don't need to be admitted to hospital. The study will last for 4 weeks and involves taking either pamapimod, pioglitazone, or a dummy pill (placebo). The main goal is to see if the medications help people feel well and symptom-free for more days. Researchers will also be looking at how long it takes for people to feel fully recovered, if the medicines prevent people from needing to go to hospital, and how the medications affect their overall symptoms. Understanding if these drugs can improve recovery for people at home is important for managing COVID-19.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Kinarus AG

Enrolment target

150

Start

03 Aug 2022

COVID-19

What is this study about?

This study is looking into new ways to help people who have mild to moderate COVID-19 and don't need to be in hospital. The researchers are testing two medicines called pamapimod and pioglitazone. Both are already approved for other conditions, but this study wants to see if they can also help people recover from COVID-19 more quickly and feel better.

The main aim is to find out if taking these medicines helps people have more days where they feel well, with very few or no COVID-19 symptoms, over a period of 28 days. The study will also be checking other things like how long it takes for someone to feel fully recovered, whether the medicines stop people from needing to go to hospital, and if they reduce the overall severity of symptoms.

This type of study, called a Phase II study, is an important step. It helps researchers understand if a new treatment is safe and if it shows promise for treating a condition, before it's tested on a larger number of people. If these medicines prove helpful, they could offer new options for managing COVID-19 at home.

Key takeaways

Tests new medicines (pamapimod and pioglitazone) for COVID-19.
Aims to help non-hospitalised patients recover quicker and reduce symptoms.
Study lasts for 28 days.
Compares active medicines to a placebo (dummy pill).
Open to adults aged 18 and over.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

You would be considered for the study if you have recently been diagnosed with COVID-19 but are not unwell enough to need hospital treatment. There will be other specific medical checks to make sure the study medicines are suitable and safe for you.

Your doctor will be able to review your full medical history and current health to determine if you meet all the necessary requirements to participate in this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have COVID-19?
Are you currently not needing to be in hospital for your COVID-19?
Are you able to take daily medication for 4 weeks?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for 28 days. You would be randomly chosen to receive either pamapimod, pioglitazone, or a dummy pill (a placebo). You won't know which one you are taking, and neither will the study team.

During the study, you'll take your assigned medicine every day for 4 weeks. You will be asked to regularly report on your symptoms and how you are feeling. This will likely involve filling out a daily symptom diary. You might also have a few visits to the clinic or check-ups over the phone to see how you're getting on and for any necessary tests, such as blood tests. This helps the researchers understand how the medicine is working and monitor your health carefully.

Potential risks and benefits

By taking part, you might benefit if the study medicines help you recover from COVID-19 faster or reduce your symptoms. However, as this is a research study, there's no guarantee the medicine will help you, or that you won't experience side effects. All possible side effects will be explained to you in detail. You are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is the main goal of this study?

The main goal is to see if combining pamapimod and pioglitazone can help people with COVID-19 recover faster and have fewer symptoms.

What kind of COVID-19 patients is this study for?

This study is for adults who have COVID-19 but don't need to be in hospital.

Will I know if I'm taking the real medicine or a dummy pill?

No, this is a 'double-blind' study, meaning neither you nor the study team will know if you're taking the active medicine or a placebo.

How long will I be in the study?

Your participation in the study will last for 28 days.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without giving a reason, and it will not affect your medical care.