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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal
Medizinische Universitaet Innsbruck Innsbruck Austria
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli Naples Italy
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Evangelismos S.A. Athens Greece
Ospedale S G Moscati Statte Italy
University Hospital Galway Galway Ireland
University Of Pecs Pecs Hungary
Hospital Universitario Virgen De Valme Sevilla Spain
Fakultna Nemocnica Trencín Trencin Slovakia
St. Olavs Hospital HF Trondheim Norway
Sykehuset Oestfold HF Kalnes Graalum Norway
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Universitetssykehuset Nord-Norge HF Tromsø Norway
Hopital Saint Antoine Paris France
Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy
University Of Debrecen Debrecen Hungary
Vestfold Hospital Trust Tonsberg Norway
Virgen del Rocío University Hospital Sevilla Spain
Assistance Publique Hopitaux De Paris Paris France
Oslo University Hospital HF Oslo Norway
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace Mulhouse France
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Vrije Universiteit Brussel Jette Belgium
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Universita Degli Studi Di Brescia Brescia Italy
University Hospital Bratislava Bratislava Slovakia
University Hospital Limerick Limerick Ireland
Univerzitna Nemocnica Martin Martin Slovakia
Hospital Universitario De Jaen Jaen Spain
Fakultna Nemocnica Trnava Trnava Slovakia
Ospedale Mater Salutis Di Legnago Legnago Italy
Ospedale Santa Maria Annunziata Bagno A Ripoli Italy
Ospedale Santa Maria Goretti Latina Latina Italy
Baerum Sykehus Gjettum Norway
Azienda Ospedaliera Ospedali Riuniti Marche Nord Pesaro Italy
Lovisenberg Diakonale Sykehus AS Oslo Norway
Ospedale Cardinal Massaia Asti Italy
Drammen Sykehus Drammen Norway
Ospedale Fabrizio Spaziani Frosinone Italy
University Of Szeged Szeged Hungary
Hospital Costa del Sol Marbella Spain
Klinikum Bremen-Mitte gGmbH Bremen Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Beaumont Hospital Dublin Ireland
Centre Hospitalier de Luxembourg Luxembourg Luxembourg
University Of Milan Milan Italy
Ospedale Santissima Trinita Cagliari Italy
Centro Hospitalar Universitário Lisboa Central E.P.E. Lisbon Portugal
Hopital Louis Mourier Colombes France
Cckcac Hecrujerqqy Uwdrxfstnjoqc Aolmua Pikinsup Amiens France
Cyonde Hmjnfcgozdo Uuzdiqkdhubwk Dp Dzrin Dijon France
Cboscs Hfuilfalnw E Uopabuqtjsjcn Du Cvxfprr Etmavj Coimbra Portugal
Cxbyxmzwo Ubhkfwitrrykij Sojypegdp Woluwe-Saint-Lambert Belgium
Hlgnl Sxgsvolgo Hr Stavanger Norway
Apfqpobh Uycqsmodpu Hrnybbnb Lorenskog Norway
Sa Vqtxcvyctkpxqyj Ussnmoovpw Hdizcweo Dublin Ireland
Cmax Uemyikipql Hkuuvunl Cork Ireland
Uvzsyuynls Muqkz Gqaoeve Or Cllryyshu Catanzaro Italy
Fjprjhkji Pdut Lt Ibzxliekdmqbf Bpershswz Dfh Hxzxodns Uvsqtdczepptf Lw Pjt Madrid Spain
Cyw Cwyap Rjuluopoyim Lyon France
Ufulyxzohd Glewrvd Hvrlgkgt Asdmahj Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
22.04.2022
Belgium Belgium
Not recruiting
22.04.2022
Czechia Czechia
Not recruiting
22.04.2022
France France
Not recruiting
22.04.2022
Germany Germany
Not recruiting
22.04.2022
Greece Greece
Not recruiting
22.04.2022
Hungary Hungary
Not recruiting
22.04.2022
Ireland Ireland
Not recruiting
22.04.2022
Italy Italy
Not recruiting
22.04.2022
Luxembourg Luxembourg
Not recruiting
22.04.2022
Norway Norway
Not recruiting
22.04.2022
Portugal Portugal
Not recruiting
22.04.2022
Slovakia Slovakia
Not recruiting
22.04.2022
Spain Spain
Not recruiting
22.04.2022

Trial locations

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.

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 ID:
2022-500385-99-00
NCT ID:
NCT04891133
Trial Phase:
Therapeutic confirmatory (Phase III)

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