Study to Evaluate the Efficacy and Safety of Maraviroc in SARS-CoV-2 Infection (COVID-19). (MARACOVID)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04441385|
Recruitment Status : Not yet recruiting
First Posted : June 22, 2020
Last Update Posted : June 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Maraviroc 300 mg Other: Standard care therapy||Phase 2|
This is a bicentric, phase 2, randomized, open-label study to evaluate the efficacy and safety of maraviroc associated with standard treatment in hospitalized patients with pulmonary SARS-CoV-2 infection (COVID-19), to prevent disease progression to severe Acute Respiratory Distress Syndrome (ARDS).
Patients will be randomized to receive maraviroc (300 mg BID for 14 days) plus standard treatment, or standard treatment alone.
200 subjects will be enrolled and randomized 1:1 in this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bicentric, Phase 2, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Maraviroc Associated With Standard Treatment in Hospitalized Patients With Pulmonary SARS-CoV-2 Infection (COVID-19).|
|Estimated Study Start Date :||June 26, 2020|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||December 20, 2020|
Experimental: Test arm
100 subjects will be randomly assigned to this arm. Patients in the test group will receive 300 mg of maraviroc BID for 14 days (added to standard care).
Drug: Maraviroc 300 mg
Patients will receive maraviroc 300 mg twice daily for 14 days
100 subjects will be randomized in this arm and will be treated according to the standard care. The Ministry of Health has issued detailed guidelines for the management of COVID-19. Local Institutional Guidelines and Protocols for supportive management will also be implemented.
Other: Standard care therapy
Subjects randomized to control group will be on standard care treatment according to the Ministry of Health and Local Guidelines and Protocols.
- Proportion of patients developing severe ARDS. [ Time Frame: 28 days ]A patient with a saturation of 90% or less despite the use of a reservoir mask without rebreathing with a flow of 7 liters per minute (FiO2 0.6 or higher), will be considered to have severe ARDS. These oximetric criteria have a close correlation with a PaO2 / FiO2 of 100 or less, which defines severe ARDS.
- All-cause mortality. [ Time Frame: 28 days ]
- Percentage of patients requiring tracheal intubation, use of Non-invasive Ventilation NIV or High Flow Nasal Cannula (HFNC) devices during the study period [ Time Frame: 28 days ]
- Percentage of patients who progress to severe ARDS, death or ICU admission. [ Time Frame: 28 days ]
- Differences in Time to Clinical Improvement [ Time Frame: 28 days ]
Defined as the time (in hours) from the start of the treatment under study to the normalization of temperature, normalization of respiratory rate and SpO2.
- Axillary temperature < 37.5ºC (oral < 37.2ºC) for 48 hours, without antipyretic treatment.
- Breathing rate < 24 rpm during the clinical evaluation and at least two consecutive daily evaluations (48 hours).
- SpO2 > 93% breathing ambient air during clinical assessment and at least two consecutive daily assessments (48 hours).
- Change in clinical status of subject on a 7-point ordinal scale. [ Time Frame: 28 days ]
The ordinal scale of 7 categories of patient health status ranges from:
- Hospitalized, with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
- Hospitalized, with non-invasive ventilation or high flow oxygen devices.
- Hospitalized, requiring supplemental oxygen.
- Hospitalized, not requiring supplemental oxygen.
- Non-hospitalized, activity limitation.
- Non-hospitalized, no activity limitation.
- Percentage of patients requiring immunosuppressive/immunomodulatory treatment as a rescue medication. [ Time Frame: 28 days ]
- Proportion of patients developing adverse effects, serious adverse reactions, laboratory or physical examination findings, EKG abnormalities acquired during the trial, death and adverse events leading to early discontinuation of treatment. [ Time Frame: 28 days ]Classification according to the WHO toxicity scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441385
|Contact: Rosa María Muñoz||+34 93 22 75 400 ext email@example.com|
|Barcelona, Spain, 08036|
|Contact: Felipe García, PhD, MD 932275400|
|Principal Investigator: Felipe García, PhD, MD|
|Sub-Investigator: Berta Torres, PhD, MD|
|Sub-Investigator: Montserrat Laguno, PhD, MD|
|Sub-Investigator: Álex Soriano, PhD, MD|
|Hospital Universitario Infanta Leonor|
|Madrid, Spain, 28031|
|Contact: Victor Domínguez, MD +3491191900 firstname.lastname@example.org|
|Principal Investigator: Victor Domínguez, MD|
|Sub-Investigator: Guillermo Cuevas, MD|
|Sub-Investigator: Pablo Ryan, MD|
|Sub-Investigator: Jesus Troya, MD|
|Principal Investigator:||Víctor Domínguez, MD||Hospital Universitario Infanta Leonor|