Not recruiting

Study on Pamapimod and Pioglitazone for COVID-19 Recovery in Non-Hospitalized Patients

Verified siteInvestigational

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What is this trial about?

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

This clinical trial is focused on studying the effects of a combination of two medications, pamapimod and pioglitazone, on the progression and recovery of COVID-19 in patients who are not hospitalized. COVID-19 is an illness caused by the virus SARS-CoV-2, which can lead to symptoms like fever, cough, and difficulty breathing. The study aims to understand how these medications might help in reducing the severity and duration of symptoms in people infected with the virus.

Participants in the study will receive either the combination of pamapimod and pioglitazone or a placebo. Pamapimod is an anti-inflammatory medication, while pioglitazone is known for its anti-inflammatory and antidiabetic properties. The study will last for four weeks, during which participants will take the medications orally in tablet form. The goal is to observe the number of days participants experience mild symptoms and to assess their overall recovery over the 28-day period.

The study will also monitor the safety and tolerability of the medication combination, as well as any potential side effects. Researchers will evaluate the time it takes for participants to recover based on their daily reports of symptoms. Additionally, the study will track any unplanned hospital admissions or deaths related to COVID-19 during the trial period. The results will help determine if this combination of medications can effectively aid in the recovery from COVID-19.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the study's purpose and procedures.
You will need to confirm your diagnosis of COVID-19 with a positive test result obtained within the last 48 hours.
Step 2
Medication administration
You will be randomly assigned to receive either the study medications or a placebo. A placebo is a substance with no active medication.
If you receive the study medications, you will take pamapimod 150 mg and pioglitazone hydrochloride 10 mg, both in tablet form, once daily by mouth for 4 weeks.
Step 3
Daily symptom evaluation
Each day, you will be asked to evaluate your symptoms. This will involve a phone call where you will report your symptoms and their severity.
The goal is to track the number of days you experience mild or no symptoms.
Step 4
End of study evaluation
At the end of the 4-week period, your symptoms and overall health will be evaluated to determine the effects of the treatment.
You will be asked about any side effects or unexpected health changes during the study.

Who can join the trial?

7 criteria

Must have a diagnosis of symptomatic COVID-19 for less than 5 days, with specific symptoms or a total symptom score as described in the study.
Must have a confirmed COVID-19 diagnosis in the last 48 hours through a positive test for the virus using a laboratory test, not a self-test.
There should be no indication that the patient will need to be hospitalized for COVID-19 in the next 48 hours.
Must be an adult aged 18 years or older.
Females must have a negative pregnancy test or be post-menopausal (no longer having menstrual periods).
Must be able to understand and willing to sign a written informed consent document, which is a form that explains the study and confirms your agreement to participate.
Must be able to understand and be available for daily phone calls to evaluate symptoms.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with COVID-19 cannot participate.
Patients who are younger than 18 years old or older than 65 years old cannot participate.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.

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Verified sites

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

Clinical Research Hamburg GmbH
Verified
Hamburg, Germany
Hno Praxis Am Neckar
Verified
Heidelberg, Germany
Praxis Ebertplatz
Verified
Cologne, Germany

Trial locations

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Investigated drugs

Pamapimod
is a medication being studied for its potential effects on COVID-19. It is taken by mouth and is thought to help reduce inflammation in the body. In this trial, researchers are looking at how pamapimod might help people recover from COVID-19 by possibly reducing the severity of symptoms and speeding up recovery time.
Pioglitazone
is another medication included in the study. It is usually used to help control blood sugar levels in people with diabetes. However, in this trial, it is being tested to see if it can help with COVID-19 recovery. Researchers are interested in whether pioglitazone can help improve symptoms and overall health in people who have been infected with the virus.

What is already known about the treatment

Pamapimod
Pamapimod is administered orally in the form of a pill. It is currently being studied in clinical trials for its potential effects on COVID-19, particularly in non-hospitalized patients. The main therapeutic indication for pamapimod in this trial is to help reduce the severity and duration of COVID-19 symptoms. At the molecular level, pamapimod works by inhibiting certain enzymes that are involved in inflammation, which may help in reducing the symptoms of the disease. It is classified pharmacologically as a kinase inhibitor.
Pioglitazone
Pioglitazone is also taken orally as a pill. It is being investigated in combination with pamapimod for its potential benefits in treating COVID-19. The primary therapeutic use of pioglitazone in this context is to aid in the recovery process of patients with COVID-19. Pioglitazone works by activating a specific receptor that helps regulate glucose and lipid metabolism, which might have beneficial effects on the immune response. It is classified as a thiazolidinedione, a type of medication commonly used to manage blood sugar levels in diabetes.

Investigated diseases

COVID-19 – COVID-19 is a respiratory illness caused by the coronavirus SARS-CoV-2. It primarily spreads through respiratory droplets when an infected person coughs, sneezes, or talks. The disease can start with mild symptoms such as fever, cough, and fatigue, but it may progress to more severe conditions like difficulty breathing and pneumonia. Some individuals may experience a loss of taste or smell, muscle aches, and sore throat. In severe cases, COVID-19 can lead to acute respiratory distress syndrome (ARDS) and require hospitalization. The progression and severity of symptoms can vary widely among individuals.