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

May 3, 2023 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maraviroc experimental group
Maraviroc tablet combined with standard treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the efficacy of Maraviroc in SARS-CoV-2 infected patients hospitalized for COVID-19 using the Ordinal scale.
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyze changes in analytical variables: changes in ambient air oxygen saturation (SatO2),related to the progression of COVID-19.
Time Frame: 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
Analytical variables related to the progression of COVID-19: changes in ambient air oxygen saturation (SatO2) (mmHg).
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.
Time Frame: 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
Changes in levels of macrophage inflammatory proteins-1 α (MIP-1 α), MIP-1 β, regulated on activation normal T cell expressed and secreted (RANTES), interleukin-6 (IL-6), IL-8, interferon-inducible protein 10 (IP-10), IL-1β, TNF-α, gamma interferon (IFN-γ), soluble cluster of differentiation 25 (CD25), β2 microglobulin, dimers D, soluble cluster of differentiation 14 (CD14), soluble cluster of differentiation 40 (CD40) ligand and soluble cluster of differentiation 163 (CD163).
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).
Time Frame: 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
Changes in levels subpopulations (classical, intermediate and non-classical monocytes) and activation markers in them. Dendritic cell subpopulations (myeloid and plasmacytoid dendritic cells) and their activation markers. Subpopulations of T lymphocytes (naive, central memory, effector memory and terminally differentiated) and markers of activation, senescence and wasting in them.
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
Time Frame: 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
Quantification of additional treatments added to the administered therapy , this is immunomodulatory treatments such as: IL-6,or IL-1 inhibitors, high-dose corticosteroids, anti-tumor necrosis factor (anti-TNF) antibodies, janus kinases (JAK) kinase inhibitors or any other immunomodulatory effect and / or under investigation
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
Time Frame: 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
Analyze changes in analytical variables:changes in neutrophils, related to the progression of COVID-19.
Time Frame: 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
Changes in levels of neutrophils in blood (x10e9/L)
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 analytical variables: changes in platelets, related to the progression of COVID-19.
Time Frame: 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
Changes in levels of platelets in blood (x10e9/L)
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
Analytical variables related to the progression of COVID-19: changes in lactate dehydrogenase (LDH).
Time Frame: 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
Changes in levels of lactate dehydrogenase in blood (U/L)
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 analytical variables: changes in C-reactive protein, related to the progression of COVID-19.
Time Frame: 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
Changes in levels of C-reactive protein in blood (mg/L)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2021

Primary Completion (Actual)

July 8, 2021

Study Completion (Actual)

July 8, 2021

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVIMAR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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