Phase II clinical trial evaluating the safety and efficacy of the drug Maraviroc combined with standard therapy versus standard therapy in patients infected with SARS-CoV-2 and hospitalised with COVID-19
Description of the Study:
- Title: Proof-of-concept Trial to Evaluate the Safety and Efficacy of Maraviroc in Severe Acute Respiratory Syndrome (SARS) Coronavirus-2 (CoV-2) Infected Patients Hospitalized for COVID-19.
- Principal Investigator: Jose Manuel Lomas.
- Center of Implementation: Hospital Universitario Virgen del Rocio.
- Study Population: 40 individuals ≥ 18 years of age infected with SARS-CoV-2 and hospitalized or emergency inpatient.
- Study Type: Phase II national single-center clinical trial.
- Design: Proof-of-concept trial evaluating standard treatment together with Maraviroc compared to treatment alone.
– The experimental group is administered the drug Maraviroc orally daily for 14 days in combination with standard treatment.
– The standard treatment group is based on the COVID-19 inpatient treatment protocol and will depend on the clinical condition of the patient.
Objectives of the Study:
Principal Objective: To evaluate the safety and efficacy of Maraviroc combined with standard therapy versus standard therapy in relation to clinical progression of COVID-19 in hospitalized patients.
(1) To analyze changes in analytical variables related to the progression of COVID-19.
(2) To study variation in biomarkers of inflammation.
(3) To analyze changes in innate (monocytes and dendritic cells) and adaptive (T lymphocytes) immune activation.
More about this Study:
Maraviroc is a drug very well tolerated which has been shown to have immune modulating properties, exerting an anti-inflammatory effect in different diseases. In COVID-19 there are very high levels of inflammation that cause damage to organs and systems. This drug could reduce this inflammation leading to a better prognosis of COVID-19.