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

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ClinicalTrials.gov Identifier: NCT04710199
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Tracking Information
First Submitted Date  ICMJE January 5, 2021
First Posted Date  ICMJE January 14, 2021
Last Update Posted Date April 6, 2021
Actual Study Start Date  ICMJE February 8, 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2021)
  • 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).
  • 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).
  • 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.
  • 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
  • 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
  • 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)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate the Safety and Efficacy of Maraviroc in Patients Hospitalized for Coronavirus Disease 2019 (COVID-19)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
In this clinical trial, standard treatment together with Maraviroc (MVC) is evaluated compared to treatment alone.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Virus Diseases
Intervention  ICMJE
  • Drug: Maraviroc experimental group
    Maraviroc tablet, 600 mg milligram, oral use,daily 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.
Study Arms  ICMJE
  • Experimental: Maraviroc experimental group
    Maraviroc tablet combined with standard treatment
    Intervention: Drug: Maraviroc experimental group
  • 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: Other: Standard treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 13, 2021)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects aged ≥ 18 years.
  • Infection confirmed by SARS-CoV-2 by polymerase chain reaction (PCR) or by antigen test, in this case, at least in the first seven days after the onset of symptoms and in any case up to 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
  • Grade 3 or 4 laboratory abnormalities.
  • Concomitant use of drugs with major pharmacological interactions with the study drugs, according to the respective technical specifications of the products.
  • Estimated creatinine clearance <50ml / min.
  • Pregnancy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jose Manuel Lomas, MD 0034955012010 jlomascabezas@yahoo.es
Contact: Clara Mª Rosso, MD 0034955012144 claram.rosso@juntadeandalucia.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04710199
Other Study ID Numbers  ICMJE COVIMAR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study Sponsor  ICMJE Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose Manuel Lomas, MD Hospitales Universitarios Virgen del Rocío
PRS Account Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP