Trial to Evaluate the Safety and Efficacy of Maraviroc in Patients Hospitalized for Coronavirus D… (NCT04710199) | Clinical Trial Compass
CompletedPhase 2
Trial to Evaluate the Safety and Efficacy of Maraviroc in Patients Hospitalized for Coronavirus Disease 2019 (COVID-19)
Spain44 participantsStarted 2021-02-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the efficacy of Maraviroc in SARS-CoV-2 infected patients hospitalized for COVID-19 using the Ordinal scale.
Timeframe: 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
Trial details
NCT IDNCT04710199
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla