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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy of Maraviroc in SARS-CoV-2 infected patients hospitalized for COVID-19 using the Ordinal scale.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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-
- •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.
研究组 & 干预措施
Maraviroc experimental group
Maraviroc tablet combined with standard treatment
干预措施: Maraviroc experimental group (Drug)
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.
干预措施: Standard treatment (Other)
结局指标
主要结局
Evaluate the efficacy of Maraviroc in SARS-CoV-2 infected patients hospitalized for COVID-19 using the Ordinal scale.
时间窗: 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.
次要结局
- Analyze changes in analytical variables: changes in ambient air oxygen saturation (SatO2),related to the progression of COVID-19.(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(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)
- Study the variation in the number of biomarkers of inflammation.(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)
- Analyze changes in the number of innate immune activation (monocytes and dendritic cells) and adaptive (T lymphocytes).(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)
- Quantify the number of immunomodulatory treatments added to therapy(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 lactate dehydrogenase (LDH).(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)
- Analyze changes in analytical variables: changes in platelets, related to the progression of COVID-19.(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)
- Analyze changes in analytical variables:changes in neutrophils, related to the progression of COVID-19.(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)
- Analyze changes in analytical variables: changes in C-reactive protein, related to the progression of COVID-19.(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)