Trial to Evaluate the Safety and Efficacy of Maraviroc in Patients Hospitalized for Coronavirus Disease 2019 (COVID-19)

NCT ID: NCT04710199

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2021-07-08

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.

Conditions

Virus Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Maraviroc experimental group

Maraviroc tablet combined with standard treatment

Group Type: EXPERIMENTAL

Maraviroc experimental group

Intervention Type: DRUG

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

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.

Group Type: OTHER

Standard treatment

Intervention Type: OTHER

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

Interventions

Maraviroc experimental group

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

Intervention Type: DRUG

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Manuel Lomas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospitales Universitarios Virgen del Rocío

Locations

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Countries

Spain

Other Identifiers

COVIMAR

Identifier Type: -

Identifier Source: org_study_id