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Study on the Effects of Oseltamivir and Drug Combination for Patients with Pneumonia

Verified siteRegistered 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 treatments for pneumonia, a condition where the lungs become inflamed, often due to an infection. The study will explore the effects of several medications, including Tamiflu (oseltamivir), Hydrocortisone, Prednisolone, and Dexamethasone. These medications are being tested to see how they might help patients recover from pneumonia, especially when it is caused by viruses like influenza.

The purpose of the study is to provide reliable estimates of how these treatments affect the chances of survival and the time it takes for patients to be discharged from the hospital. Participants in the study will receive one of the medications or a placebo, and their progress will be monitored over a period of time. The study aims to understand which treatments are most effective in helping patients recover from pneumonia.

During the study, patients will be given the medication in different forms, such as capsules, tablets, or injections, depending on the specific treatment. The study will last for a maximum of 10 days for each participant, and their health will be closely observed to gather information on the effectiveness of the treatments. The results will help doctors make better decisions about how to treat pneumonia in the future.

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 study

    Upon joining the study, eligibility is confirmed based on criteria such as being hospitalized, aged 18 or older, and having a pneumonia syndrome.

    The study focuses on patients with specific diagnoses, including confirmed influenza A or B infection or community-acquired pneumonia.

  2. Step 2

    Treatment allocation

    Participants are randomly assigned to receive one of the study treatments.

    The treatments include oseltamivir (Tamiflu 75 mg hard capsules) taken orally, hydrocortisone (100 mg powder for solution) administered via IV infusion, prednisolone (10 mg tablets) taken orally, dexamethasone (3.3 mg/ml solution) administered via injection, and dexamethasone (2.0 mg tablets) taken orally.

  3. Step 3

    Treatment administration

    The medications are administered according to the assigned treatment group.

    The frequency and duration of administration depend on the specific treatment protocol for each medication.

  4. Step 4

    Monitoring and assessment

    Participants are monitored for their response to the treatment, including any side effects or changes in their condition.

    The primary focus is on the effect of the treatments on mortality and the time to discharge from the hospital.

  5. Step 5

    End of study participation

    The study aims to assess outcomes such as 28-day all-cause mortality and time to discharge alive from the hospital.

    Participation in the study concludes after the specified observation period, which may last up to 28 days.

Who can join the trial?

8 criteria

  • Patients must be **hospitalized** and **18 years or older**.
  • Must have a **pneumonia syndrome**, which means a clinical diagnosis based on:
    • Typical symptoms of a new respiratory infection.
    • Objective evidence of acute lung disease, such as **hypoxia** (low oxygen levels in the blood), compatible imaging, or clinical examination.
    • Other possible causes are considered unlikely.
    • Must have one of the following diagnoses:
      • Confirmed **influenza A or B infection**.
      • **Community-acquired pneumonia** with planned antibiotic treatment, without suspected or confirmed **SARS-CoV-2**, influenza, active **pulmonary tuberculosis**, or **Pneumocystis pneumonia**.
      • No medical history that might, in the opinion of the patient’s doctor, put the patient at significant risk if they were to participate in the trial.
      • No reason that the trial treatment definitely should, or should not, be given, in the opinion of the patient’s doctor. This only affects eligibility for the relevant comparison.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with pneumonia cannot participate. Pneumonia is an infection that inflames the air sacs in one or both lungs.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate. This group includes individuals with certain characteristics needed for the study.
  • Patients who are not able to give informed consent or understand the study requirements cannot participate.
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Investigated drugs

  • Dexamethasone

    is a medication used in this trial to help reduce inflammation in the body. It is a type of steroid that can help improve breathing and reduce the severity of symptoms in patients with severe respiratory issues, such as those caused by COVID-19.

  • Tocilizumab

    is an immunosuppressive drug that is used to treat severe inflammation. In the context of this trial, it is being tested to see if it can help reduce the immune system's overreaction in patients with severe COVID-19, potentially improving their outcomes.

  • Baricitinib

    is a medication that works by interfering with the activity of certain enzymes in the body that are involved in inflammation. It is being studied in this trial to determine if it can help reduce the severity of COVID-19 symptoms by modulating the immune response.

  • Regeneron

    is a combination of monoclonal antibodies designed to target the coronavirus. This therapy aims to help the immune system fight off the virus more effectively, potentially reducing the severity and duration of the illness in patients with COVID-19.

  • Convalescent Plasma

    is a therapy that involves using blood plasma from people who have recovered from COVID-19. The plasma contains antibodies that may help patients currently fighting the virus by boosting their immune response.

What is already known about the treatment

Dexamethasone – Dexamethasone is administered orally or intravenously, depending on the severity of the condition being treated. It is currently recognized in medical literature as an effective treatment for reducing inflammation and modulating the immune response. The main therapeutic indication for dexamethasone in the context of the RECOVERY trial is to treat severe respiratory complications, such as pneumonia, associated with COVID-19. At the molecular level, dexamethasone works by binding to glucocorticoid receptors, which leads to the suppression of pro-inflammatory cytokines and the reduction of immune system activity. It is classified pharmacologically as a corticosteroid.

Investigated diseases

Pneumonia – Pneumonia is an infection that inflames the air sacs in one or both lungs, which may fill with fluid or pus. This condition can cause symptoms such as cough, fever, chills, and difficulty breathing. It can be caused by a variety of organisms, including bacteria, viruses, and fungi. The disease can range from mild to severe, depending on factors like the type of germ causing the infection and the individual's age and overall health. As the infection progresses, it can lead to complications such as pleurisy, lung abscesses, or acute respiratory distress syndrome. Recovery time can vary, with some individuals experiencing prolonged fatigue and weakness even after the infection has cleared.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507441-29-00Estimated enrolment1 590 patientsSponsorUniversity Of Oxford

sourced from the EU Clinical Trials Register and site verification

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