Clinical trial NCT04710199: Trial to Evaluate the Safety and Efficacy of Maraviroc in Patients Hospitalized for Coronavirus Disease 2019 (COVID-19)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Virus Diseases
Keywords: Sar-COv19
coronavirus
COVID19
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this clinical trial, standard treatment together with Maraviroc (MVC) is evaluated compared to treatment alone.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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, portal hypertension and / or hypersplenism of any etiology.
* Past or current neoplasms subsidiary to treatment with steroids, immunomodulators or chemotherapy
* Laboratory abnormalities.
* Concomitant use of drugs with major pharmacological interactions with the study drugs, according to the respective technical specifications of the products.
* Pregnancy.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Analyze changes in analytical variables: changes in ambient air oxygen saturation (SatO2),related to the progression of COVID-19.
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
measure: Study the variation in the number of biomarkers of inflammation.
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
measure: Analyze changes in the number of innate immune activation (monocytes and dendritic cells) and adaptive (T lymphocytes).
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
measure: Quantify the number of immunomodulatory treatments added to therapy
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
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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
measure: Analyze changes in analytical variables:changes in neutrophils, related to the progression of COVID-19.
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
measure: Analyze changes in analytical variables: changes in platelets, related to the progression of COVID-19.
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
measure: Analytical variables related to the progression of COVID-19: changes in lactate dehydrogenase (LDH).
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
measure: Analyze changes in analytical variables: changes in C-reactive protein, related to the progression of COVID-19.
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
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocío
name: Jose Manuel Lomas, MD
role: PRINCIPAL_INVESTIGATOR
References: