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Study on Baricitinib for Hospitalized Patients with Severe or Critical COVID-19

Fast replyRegistered drugNo 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 effects of a medication called baricitinib on patients with COVID-19, which is caused by the SARS-CoV-2 virus. The study aims to understand how this medication, when added to the standard care, affects the progression of the disease in hospitalized patients who are immunocompromised, meaning their immune system is weakened. The trial will compare the effects of baricitinib to a placebo, which is a substance with no active medication, to see if there is a difference in outcomes.

The purpose of the study is to determine if baricitinib can help reduce the risk of death in patients with severe or critical COVID-19. Participants in the study will receive either the medication or a placebo, and their health will be monitored to see how the disease progresses. The study will look at whether the medication can prevent the disease from getting worse and if it can help patients recover more quickly.

Throughout the study, participants will be closely observed to track their recovery and any changes in their condition. The trial will also assess various health markers to understand the impact of the treatment. This research is part of a larger effort to find effective treatments for COVID-19 and improve outcomes for patients with this disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. 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 that you are at least 18 years old and have a laboratory-confirmed SARS-CoV-2 infection that is not more than 14 days old.

  2. Step 2

    Hospital admission

    You must be admitted to the hospital to participate in this study. The study focuses on patients with moderate to severe COVID-19 symptoms.

    Your condition will be assessed to determine if you meet the criteria for moderate or severe disease.

  3. Step 3

    Treatment assignment

    You will be randomly assigned to receive either the medication baricitinib or a placebo. A placebo is a substance with no active medication, used to compare effects.

    The medication is administered as a 2 mg film-coated tablet taken orally.

  4. Step 4

    Medication administration

    You will take the assigned tablet once daily. The duration of administration will depend on your response to the treatment and the study's protocol.

    Your health will be monitored closely during this period to observe any changes in your condition.

  5. Step 5

    Monitoring and assessments

    Throughout the study, your health will be regularly monitored. This includes checking inflammatory markers and other health indicators.

    You may undergo various tests, such as blood tests and oxygen level assessments, to track your progress.

  6. Step 6

    End of study participation

    Your participation in the study will conclude after a specified period, or if your condition changes significantly.

    The study aims to determine the effect of the treatment on disease progression and survival rates.

Who can join the trial?

16 criteria

  • Must be 18 years or older.
  • Must have a laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) confirmed by a PCR test within the last 14 days.
  • Must be admitted to the hospital.
  • Must provide informed consent to participate, or have a legally authorized representative provide consent.
  • Must have a severe or critical disease state, which means at least one of the following:
    • Oxygen level (SpO2) less than 90% on room air.
    • Oxygen level between 90-94% with a downward trend and/or signs of breathing difficulty, such as increased breathing rate, use of extra muscles to breathe, or inability to complete full sentences.
    • Need for oxygen through non-invasive methods like CPAP (Continuous Positive Airway Pressure) or BIPAP (Bi-level Positive Airway Pressure), high flow oxygen, or a non-rebreather mask.
    • Need for mechanical ventilation or ECMO (Extracorporeal Membrane Oxygenation), which are advanced methods to support breathing.
    • Must be immunocompromised, meaning having a weakened immune system due to conditions like:
      • Certain blood cancers or pre-cancerous conditions, except acute leukemia or history of lymphoma.
      • Being an organ transplant recipient, except those who had a bone marrow or solid organ transplant in the last 6 months, or experienced transplant rejection in the last 6 months.
      • HIV positive with a CD4 count less than 350 cells and on stable antiretroviral therapy.
      • Primary immunodeficiency, which is a condition present from birth that affects the immune system.
      • Autoimmune disorders like rheumatoid arthritis, lupus, vasculitis, or inflammatory bowel disease, for which the patient is being treated with systemic immunosuppressive medication.
      • Must have an elevation of 2 or more inflammatory markers above specific levels:
        • Ferritin greater than 700 ug/l.
        • LDH (Lactate Dehydrogenase) greater than 400 U/L.
        • CRP (C-reactive protein) greater than 75 mg/L.

Who cannot join the trial?

5 criteria

  • Patients who do not have a confirmed infection with SARS-CoV II (the virus that causes COVID-19).
  • Patients who are not hospitalized with moderate, severe, or critical COVID-19.
  • Patients who are not immunocompromised. This means their immune system is not weakened or less able to fight infections.
  • Patients who are not within the specified age range for the study.
  • Patients who do not meet other specific health criteria required for the study.
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Investigated drugs

Baricitinib is a medication that is being studied for its potential to help patients with severe or critical COVID-19, especially those who have weakened immune systems. It works by reducing inflammation in the body, which can be a significant problem in severe COVID-19 cases. By doing so, it may help prevent the disease from getting worse and reduce the risk of death in hospitalized patients. This medication is being compared to a placebo to see if it provides any additional benefits when added to the standard care that patients are already receiving.

What is already known about the treatment

Baricitinib – Baricitinib is administered orally in the form of tablets and is currently being studied for its effectiveness in treating severe or critical COVID-19 in hospitalized patients, particularly those who are immunocompromised. It is primarily used to reduce the risk of death in these patients. The medication works by inhibiting specific enzymes called Janus kinases, which play a role in the inflammatory process, thereby potentially reducing inflammation and improving patient outcomes. Baricitinib is classified as a Janus kinase inhibitor, a type of medication that helps manage immune responses.

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 symptoms to moderate, severe, or critical states, with severe cases potentially requiring hospitalization. In moderate cases, patients may experience increased respiratory distress and require supplemental oxygen. Severe cases can lead to acute respiratory distress syndrome (ARDS), necessitating mechanical ventilation. Critical cases may involve multi-organ failure and require intensive care support.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500385-99-00Estimated enrolment2 000 patientsSponsorOslo University Hospital HF

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).