Study to Evaluate the Efficacy and Safety of Maraviroc in SARS-CoV-2 Infection (COVID-19).

• Status: Recruiting
• Trial end date: 2020-12-20
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Infanta Leonor
• Collaborators: Hospital Clínic de Barcelona; Hospital Clinic of Barcelona; ViiV Healthcare
• Treatments: Maraviroc

Criteria

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.