Official 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
Brief Summary

Maraviroc (MVC) is a drug, very well tolerated, it has been seen that MVC has properties of modulating the immune system, exerting an anti-inflammatory effect in different diseases. In COVID-19, very high levels of inflammation occur that cause organs and systems to be damaged. MVC could reduce this inflammation achieving a better prognosis of COVID-19.

Detailed Description

In this clinical trial the investigators want to evaluate if standard treatment together with
Maraviroc (MVC) compared to standard treatment alone, achieves better clinical evolution in
participants hospitalized for COVID-19.

Completed
Virus Diseases

Drug: Maraviroc experimental group

300-milligram dose of the drug two times daily , oral way. During 14 days.

Other: Standard treatment

It is based on the treatment protocol for hospitalized COVID-19 patients and that will depend on the clinical status of the patient.

Eligibility Criteria

Inclusion Criteria:

- Subjects aged ≥ 18 years.

- Infection confirmed by SARS-CoV-2 by polymerase chain reaction (PCR) at least 3 days
before randomization.

- Hospitalized or emergency patient in hospitalization phase.

- Mild / moderate pneumonia, with fever, persistent cough and severe asthenia, confirmed
by imaging tests (conventional radiology or computerized axial tomography (CT)) with
ambient air oxygen saturation (SatO2)> 94%.

- Less than 12 days from the onset of symptoms.

- Women of childbearing potential must have a negative serum or urine pregnancy test
prior to inclusion in the study and must commit to using highly effective
contraceptive methods (intrauterine device, bilateral tubal occlusion, vasectomized
partner, and sexual abstinence).

- Accepts written consent or oral informed in the case that due to the relevant security
protocols, written consent is not possible.

Exclusion Criteria:

- Patient with severe pneumonia confirmed by imaging test (conventional radiology or
computerized axial tomography (CT)) with ambient air oxygen saturation (SatO2) ≤94%.

- Another acute active infection other than that produced by SARS-CoV-2.

- Chronic renal failure (estimated glomerular filtration ≤ 30 ml / min / 1.73 m2 or
receiving renal replacement therapy in any of its modalities).

- Known HIV infection. Unless the patient has> 500 CD4 + / mm3 and an undetectable viral
load for more than 6 months.

- Active co-infection with known hepatitis B or C viruses.

- Cirrhosis, portal hypertension and / or hypersplenism of any etiology.

- Past or current neoplasms subsidiary to treatment with steroids, immunomodulators or
chemotherapy

- Laboratory abnormalities.

- Concomitant use of drugs with major pharmacological interactions with the study drugs,
according to the respective technical specifications of the products.

- Pregnancy.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Spain
Locations

Hospital Universitario Virgen del Rocio
Sevilla, Spain

Hospital Universitario Virgen del Rocío
Sevilla, Spain

Jose Manuel Lomas, MD, Principal Investigator
Hospitales Universitarios Virgen del Rocío

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
NCT Number
Keywords
Sar-COv19
Coronavirus
COVID19
MeSH Terms
COVID-19
Coronavirus Infections
Virus Diseases
Maraviroc