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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maraviroc experimental group | Experimental | Maraviroc tablet combined with standard treatment |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maraviroc experimental group | Drug | 300-milligram dose of the drug two times daily , oral way. During 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Manuel Lomas, MD | Hospitales Universitarios Virgen del Rocío | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain | |||
| Hospital Universitario Virgen del Rocío |
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In this clinical trial, standard treatment together with Maraviroc (MVC) is evaluated compared to treatment alone.
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| 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. |
|
| 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). | 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). | 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 | 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 | 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. | 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. | 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). | 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. | 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 |
| Seville |
| 41013 |
| Spain |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D007239 | Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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