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 range18 Years
SexALL
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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…
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