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).
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.
Drug: Maraviroc 300 mg
Patients will receive maraviroc 300 mg twice daily for 14 days
Other Name: Array
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.
Inclusion Criteria:
- 1. Male or female adult ≥ 18 years of age at the time of giving informed consent.
- 2. Subject is hospitalized.
- 3. SARS-CoV-2 infection confirmed by PCR or other commercial or public health tests,
in any biological sample obtained up to 4 days prior to randomization, or that meets
locally accepted criteria for clinical diagnosis of COVID-19.
- 4. Lung involvement confirmed by at least one of the following criteria:
1. Radiological infiltrates on imaging test (conventional radiography, computed
tomography (CT) or other)
2. In the absence of radiological infiltrates, an SpO2 < 95% without oxygen
supporting therapy (breathing ambient air), combined with cough, crackles on
physical exam, or an LDH > 300 U/L with no other cause.
- 5. Symptom onset ≤ 8 days prior to randomization.
- 6. Understands and agrees to comply with planned study procedures.
- 7. Women of childbearing potential must have a negative test for pregnancy (blood or
urine) before their inclusion and agree to use an accepted method of contraception for
the duration of the study.
- 8. Subject (or legally authorized representative) provides written informed consent
prior to initiation of any study procedures.
Exclusion Criteria:
- 1. SpO2 ≤ 91% breathing ambient air and SpO2 < 95% with oxygen in nasal cannula at 2
lpm.
- 2. Patient's attending physician considers the study is not the best medical option,
or follow-up after discharge will be difficult.
- 3. A patient who, in the investigator's opinion, is unlikely to survive > 48 hours
from inclusion in the study.
- 4. Patients with severe chronic kidney disease (ClCr < 30 ml/min/1.73 m2 or receiving
renal replacement therapy in any of its modalities).
- 5. Severe liver disease (Child-Pugh C, ALT > 5 times above upper limit of normal
(LSN).
- 6. COPD with FEV1 < 70.
- 7. Known active neoplasia.
- 8. HIV infection. Patients with known HIV infection, under follow-up, and
immunovirological stability (CD4> 500 and undetectable viral load) for at least 6
months before inclusion in this study may be included.
- 9. Hemoglobin < 9 gr/dL.
- 10. Prolonged QT, defined as a QT interval > 460 ms. (or > 450 ms. in case of family
history of sudden death or long QT syndrome or personal history of repeat syncope
without an etiological diagnosis). This criterion will only apply if the standard
treatment contains drugs with an effect on the duration (prolongation) of the QT
interval.
- 11.Significant cardiovascular disease, including:
1. History of acute myocardial infarction, acute coronary syndrome (unstable angina,
coronary by-pass surgery, angioplasty, or coronary stenting) ≤ 6 months prior to
randomization
2. Symptomatic heart failure (NYHA grade 2 or more) history, or current evidence of
cardiac arrhythmia (except atrial fibrillation or flutter and paroxysmal
supraventricular tachycardia) and/or conduction abnormalities (excluding branch
blocks or Wenckebach grade I and II atrioventricular blocks).
- 12. Known or suspected active autoimmune disease
- 13. Pregnancy or breastfeeding, or positive pregnancy test at baseline or screening
visit
- 14. Patients who are expected to be transferred to another facility sooner than 72
hours after inclusion in the study.
- 15. Patients who have received experimental treatment (off-label, compassionate use,
or in clinical trials) within 30 days prior to the screening visit, except for
treatment considered standard initiated on admission to hospital, up to 48 hours
before inclusion in the study.
- 16. Patients who have a history of allergic reactions to maraviroc or any of its
components.
Hospital Clínic
Barcelona, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Víctor Domínguez, MD, Principal Investigator
Hospital Universitario Infanta Leonor