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

Primary Purpose

Virus Diseases

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Maraviroc experimental group
Standard treatment
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Virus Diseases focused on measuring Sar-COv19, coronavirus, COVID19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Virgen del Rocio
  • Hospital Universitario Virgen del Rocío

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Maraviroc experimental group

Standard treatment

Arm Description

Maraviroc tablet combined with 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Analyze changes in analytical variables: changes in ambient air oxygen saturation (SatO2),related to the progression of COVID-19.
Analytical variables related to the progression of COVID-19: changes in ambient air oxygen saturation (SatO2) (mmHg).
Study the variation in the number of biomarkers of inflammation.
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).
Analyze changes in the number of innate immune activation (monocytes and dendritic cells) and adaptive (T lymphocytes).
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.
Quantify the number of immunomodulatory treatments added to therapy
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
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Analyze changes in analytical variables:changes in neutrophils, related to the progression of COVID-19.
Changes in levels of neutrophils in blood (x10e9/L)
Analyze changes in analytical variables: changes in platelets, related to the progression of COVID-19.
Changes in levels of platelets in blood (x10e9/L)
Analytical variables related to the progression of COVID-19: changes in lactate dehydrogenase (LDH).
Changes in levels of lactate dehydrogenase in blood (U/L)
Analyze changes in analytical variables: changes in C-reactive protein, related to the progression of COVID-19.
Changes in levels of C-reactive protein in blood (mg/L)

Full Information

First Posted
January 5, 2021
Last Updated
May 3, 2023
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT04710199
Brief Title
Trial to Evaluate the Safety and Efficacy of Maraviroc in Patients Hospitalized for Coronavirus Disease 2019 (COVID-19)
Acronym
COVIMAR
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virus Diseases
Keywords
Sar-COv19, coronavirus, COVID19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
In this clinical trial, standard treatment together with Maraviroc (MVC) is evaluated compared to treatment alone.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maraviroc experimental group
Arm Type
Experimental
Arm Description
Maraviroc tablet combined with standard treatment
Arm Title
Standard treatment
Arm Type
Other
Arm Description
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
Drug
Intervention Name(s)
Maraviroc experimental group
Intervention Description
300-milligram dose of the drug two times daily , oral way. During 14 days.
Intervention Type
Other
Intervention Name(s)
Standard treatment
Intervention Description
It is based on the treatment protocol for hospitalized COVID-19 patients and that will depend on the clinical status of the patient.
Primary Outcome Measure Information:
Title
Evaluate the efficacy of Maraviroc in SARS-CoV-2 infected patients hospitalized for COVID-19 using the Ordinal scale.
Description
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.
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
Secondary Outcome Measure Information:
Title
Analyze changes in analytical variables: changes in ambient air oxygen saturation (SatO2),related to the progression of COVID-19.
Description
Analytical variables related to the progression of COVID-19: changes in ambient air oxygen saturation (SatO2) (mmHg).
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
Title
Study the variation in the number of biomarkers of inflammation.
Description
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).
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
Title
Analyze changes in the number of innate immune activation (monocytes and dendritic cells) and adaptive (T lymphocytes).
Description
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.
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
Title
Quantify the number of immunomodulatory treatments added to therapy
Description
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
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
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
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
Title
Analyze changes in analytical variables:changes in neutrophils, related to the progression of COVID-19.
Description
Changes in levels of neutrophils in blood (x10e9/L)
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
Title
Analyze changes in analytical variables: changes in platelets, related to the progression of COVID-19.
Description
Changes in levels of platelets in blood (x10e9/L)
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
Title
Analytical variables related to the progression of COVID-19: changes in lactate dehydrogenase (LDH).
Description
Changes in levels of lactate dehydrogenase in blood (U/L)
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
Title
Analyze changes in analytical variables: changes in C-reactive protein, related to the progression of COVID-19.
Description
Changes in levels of C-reactive protein in blood (mg/L)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Manuel Lomas, MD
Organizational Affiliation
Hospitales Universitarios Virgen del Rocío
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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