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Study on the Effectiveness and Safety of Bemcentinib for Hospitalized Patients with Moderate COVID-19

Fast replyInvestigationalNo placebo
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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 treatment of COVID-19, a disease caused by the SARS-CoV-2 virus, which can lead to respiratory symptoms and other health issues. The treatment being tested is a medication called Bemcentinib, which is taken in capsule form. Bemcentinib is a type of drug known as a receptor tyrosine kinase inhibitor, which means it works by blocking certain proteins that may help the virus spread in the body. The study will compare the effects of Bemcentinib combined with standard care to a placebo combined with standard care in patients who are hospitalized with moderate COVID-19.

The purpose of the study is to evaluate how effective Bemcentinib is in improving the condition of patients with moderate COVID-19. Participants in the study will receive either Bemcentinib or a placebo, along with the usual care provided in hospitals. The study will monitor the patients' health over a period of time to see if there are any changes in their condition, such as improvement or worsening of symptoms. The study will also look at other factors, such as how quickly patients recover and any side effects they may experience.

Throughout the study, various health indicators will be assessed, including the patients' disease state on a scale used by the World Health Organization (WHO) and the levels of oxygen in their blood. The study will also track the occurrence of any serious health events and the time it takes for patients to be discharged from the hospital. By the end of the study, researchers hope to gather valuable information about the potential benefits and safety of using Bemcentinib to treat COVID-19.

The research process

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

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be required to provide informed consent. This means you agree to participate after understanding the trial's purpose and procedures.

    You must be over 18 years of age and have a confirmed SARS-CoV-2 infection through a PCR or antigen test not older than 10 days.

  2. Step 2

    Hospital admission

    You will be admitted to the hospital with a moderate COVID-19 condition. This means you may have lower respiratory symptoms and might need oxygen through a mask or nasal prongs.

  3. Step 3

    Treatment administration

    You will receive either the bemcentinib capsules or a placebo. The capsules are taken orally.

    The dosage and frequency of the medication will be determined by the medical team based on the trial protocol.

  4. Step 4

    Monitoring and assessments

    Your health will be monitored regularly. This includes checking your disease state using an 11-point scale on Day 8, Day 15, and Day 29.

    Additional assessments will include checking for any disease progression, measuring oxygen levels, and monitoring for any adverse events.

  5. Step 5

    Follow-up

    After the initial treatment period, follow-up assessments will occur to evaluate your recovery and any long-term effects.

    You will be asked to complete a questionnaire about your health and quality of life after 90 days.

Who can join the trial?

6 criteria

  • Must be over 18 years of age.
  • Must have a documented laboratory-confirmed SARS-CoV-2 infection. This means a positive result from a PCR or antigen test for COVID-19, taken from any sample, and the test must be no more than 10 days old.
  • Must be admitted to the hospital.
  • Must provide informed consent. This means you agree to participate in the study after being fully informed about it.
  • Must have a moderate disease state. This means you are hospitalized but do not need oxygen therapy, or you need oxygen by mask or nasal prongs.
  • Must have moderate pulmonary COVID-19 disease. This means mainly lower respiratory symptoms and either a need for oxygen by mask or nasal prongs, or current radiologic evidence (like an X-ray) showing new lung changes consistent with COVID-19 pneumonia.

Who cannot join the trial?

3 criteria

  • Patients who are not hospitalized with moderate **COVID-19** cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

Bemcentinib is a medication being studied for its potential to help treat patients with moderate COVID-19. It works by blocking a specific protein in the body that may play a role in how the virus affects cells. By inhibiting this protein, bemcentinib might help reduce the severity of the disease and improve recovery in hospitalized patients. This medication is being tested alongside the usual care that patients receive in the hospital to see if it can provide additional benefits.

What is already known about the treatment

Bemcentinib – Bemcentinib is administered orally and is currently being studied for its effectiveness in treating moderate COVID-19 in hospitalized patients. It is an investigational drug, meaning it is still under research and not yet widely used in standard medical practice. The main therapeutic indication for bemcentinib is to help manage COVID-19 by potentially improving the condition of patients. At the molecular level, bemcentinib works by inhibiting a protein called AXL, which may play a role in the progression of the disease. It is classified pharmacologically as an AXL inhibitor.

Investigated diseases

COVID-19 – COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. It primarily affects the respiratory system, leading to symptoms such as fever, cough, and difficulty breathing. The disease can progress from mild to moderate, and in some cases, to severe or critical stages. In moderate cases, patients may experience pneumonia without the need for supplemental oxygen. Severe cases can lead to acute respiratory distress syndrome (ARDS) and require mechanical ventilation. The progression of the disease is monitored using clinical scales, and it can vary significantly among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500363-12-00Protocol codeAXL-SolidActEstimated enrolment400 patientsSponsorOslo University Hospital HF

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