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

NCT04710199 | Completed Phase 2

• 1 other identifier: COVIMAR
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Virus Diseases

Keywords

Sar-COv19; coronavirus; COVID19

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of Maraviroc in SARS-CoV-2 infected patients hospitalized for COVID-19 using the Ordinal scale.

  Ordinal scale: (1) Not hospitalized, without limitations in activities; (2) Not hospitalized, limitations in activities; (3) Hospitalized, with no oxygen supplement requirement; (4) Hospitalized, requiring supplemental oxygen; (5) Hospitalized, with non-invasive ventilation or high flow oxygen device or oxygen mask with reservoir); (6) Hospitalized, with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (7) Death. treatment versus standard treatment, in relation to the clinical progression of COVID-19 in hospitalized patients.

  Baseline, change from baseline at 7 days, change from baseline at 14 days, change from baseline at 21 days and change from baseline at 28 days

Secondary Outcomes (9)

• Analyze changes in analytical variables: changes in ambient air oxygen saturation (SatO2),related to the progression of COVID-19.

  Baseline, change from baseline at 7 days, change from baseline at 14 days, change from baseline at 21 days and change from baseline at 28 days

• Study the variation in the number of biomarkers of inflammation.

  Baseline, change from baseline at 7 days, change from baseline at 14 days, change from baseline at 21 days and change from baseline at 28 days

• Analyze changes in the number of innate immune activation (monocytes and dendritic cells) and adaptive (T lymphocytes).

  Baseline, change from baseline at 7 days, change from baseline at 14 days, change from baseline at 21 days and change from baseline at 28 days

• Quantify the number of immunomodulatory treatments added to therapy

  Baseline, change from baseline at 7 days, change from baseline at 14 days, change from baseline at 21 days and change from baseline at 28 days

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Baseline, change from baseline at 7 days, change from baseline at 14 days, change from baseline at 21 days and change from baseline at 28 days

Study Arms (2)

Maraviroc experimental group

EXPERIMENTAL

Maraviroc tablet combined with standard treatment

Drug: Maraviroc experimental group

Standard treatment

OTHER

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

Other: Standard treatment

Interventions

Maraviroc experimental group DRUG

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

Maraviroc experimental group

Standard treatment OTHER

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

Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (2)

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Virus Diseases; Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jose Manuel Lomas, MD

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this clinical trial, standard treatment together with Maraviroc (MVC) is evaluated compared to treatment alone.

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 14, 2021
• Study Start: February 23, 2021
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

ES (2)