Evaluation of Dexamethasone, Hydrocortisone, Prednisolone, and Oseltamivir in the Treatment of Pneumonia in Hospitalized Patients

The primary objective of the study titled "RANDOMISED EVALUATION OF COVID-19 THERAPY (RECOVERY)" is to provide reliable estimates of the effect of study treatments on **mortality** and time to discharge from hospital in patients with **pneumonia**. This objective is clinically relevant as it aims to determine the efficacy of various treatments in reducing mortality rates and hospital stay duration, which are critical outcomes in the management of COVID-19-related pneumonia.

Secondary objectives include assessing the effect of study treatment on progression to invasive mechanical ventilation or extracorporeal membrane oxygenation. This is important for understanding the potential of treatments to prevent severe respiratory complications, thereby improving patient outcomes and reducing the burden on healthcare resources.

The clinical trial involves a study population comprising **hospitalized patients** aged 18 years and older, diagnosed with **pneumonia** syndrome. Both male and female participants are included, and the trial considers a vulnerable population. The total number of participants is not specified as the sponsor has not provided this information. Participants were selected based on specific inclusion criteria, such as having a clinical diagnosis of pneumonia with typical symptoms of a new respiratory infection and objective evidence of acute lung disease. Eligible participants must have one of the following diagnoses: confirmed influenza A or B infection or community-acquired pneumonia with planned antibiotic treatment, excluding those with suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis, or Pneumocystis pneumonia. The trial excludes individuals with a medical history that might pose a significant risk if they were to participate, as determined by their doctor. Additionally, there should be no definitive reason, in the opinion of the patient's doctor, that the trial treatment should or should not be administered. Lifestyle considerations such as diet, physical activity, or habits are not detailed in the provided data.

The clinical trial is designed to evaluate the efficacy of various treatments for **pneumonia** in hospitalized patients. The trial employs a **randomized**, **controlled**, and **double-blind** methodology to ensure the reliability of the results. The primary objective is to provide reliable estimates of the effect of study treatments on mortality and time to discharge from the hospital. The trial is expected to run until June 30, 2026, with recruitment starting on December 1, 2023.

Participants will be involved in the study for a maximum treatment period of 10 days. The trial includes several study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (≥18 years) and a clinical diagnosis of pneumonia. Follow-up visits will be conducted to monitor the participants' response to treatment and any adverse events. The end-of-study visit will assess the primary endpoints, including 28-day all-cause mortality and time to discharge alive from the hospital within 28 days for patients with influenza.

Participants may be withdrawn from the study if they experience significant adverse effects, if the treating physician deems it necessary for their safety, or if they withdraw consent. The trial will also monitor secondary endpoints, such as progression to invasive mechanical ventilation or death within 28 days. The study treatments include **dexamethasone**, **hydrocortisone**, **prednisolone**, and **oseltamivir**, administered in various forms such as tablets, solutions for injection, and capsules, with specific dosing regimens tailored to each medication.

The clinical trial involves the administration of several **experimental medications**. The first medication is **Dexamethasone Tablets BP 2.0mg**, which is provided in tablet form. The active substance is **dexamethasone** as per the European Pharmacopoeia. The tablets are administered orally with a maximum daily dose of 60 mg and a total maximum dose of 600 mg over a treatment period of up to 10 days. The pharmaceutical product is manufactured by Aspen Pharma Trading Limited.

Another treatment used in the trial is **Hydrocortisone 100 mg**, available as a powder for solution for injection or infusion. The active substance is **hydrocortisone sodium succinate**. This medication is administered via intravenous infusion, with a maximum daily dose of 160 mg and a total maximum dose of 1600 mg over a 10-day period. The product is produced by Panpharma.

**Prednisolone 10mg Tablets** are also included in the study. The active substance is **prednisolone**, and the tablets are administered orally. The maximum daily dose is 40 mg, with a total maximum dose of 400 mg over a 10-day treatment period. Accord-UK Limited is the manufacturer of this pharmaceutical product.

The trial also includes **Dexamethasone 3.3 mg/ml solution for injection**, with the active substance being **dexamethasone sodium phosphate**. This solution is administered via intravenous infusion, with a maximum daily dose of 60 mg and a total maximum dose of 600 mg over a 10-day period. Hameln Pharma Ltd is responsible for the production of this medication.

Lastly, **Tamiflu 75 mg hard capsules** are used in the trial, containing the active substance **oseltamivir**. These capsules are administered orally, with a maximum daily dose of 150 mg and a total maximum dose of 1500 mg over a 10-day period. The capsules are manufactured by Roche Registration GmbH.

All medications are administered according to the specified dosing schedules, and participant compliance is monitored throughout the trial to ensure adherence to the treatment protocols. No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are mentioned in the trial data provided.

The efficacy of treatments in the clinical trial titled "RANDOMISED EVALUATION OF COVID-19 THERAPY (RECOVERY)" will be assessed using specific primary and secondary endpoints. The primary endpoints include **28-day all-cause mortality** and the time to discharge alive from the hospital within 28 days for patients with influenza. Secondary endpoints involve the time to discharge alive from the hospital within 28 days for patients without influenza and the progression to invasive mechanical ventilation or death within 28 days.

These endpoints will be measured and collected at specified time points, with a focus on the 28-day period following treatment initiation. The analysis will involve comparing the outcomes of patients receiving the study treatments to those not receiving them, to provide reliable estimates of the effect of the treatments on mortality and hospital discharge times. The trial is designed to ensure that medications are used within their marketing authorization, aligning with the trial's low-intervention category. The study is expected to conclude by June 30, 2026, with recruitment starting on December 1, 2023.