Clinical study to assess the efficacy and safety of maraviroc in coronavirus lung infection (COVID-19).

Phase 1

• Conditions: COVID-19 Pneumonia; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002011-21-ES
• Lead Sponsor: Fundación para la Investigación e Innovación Biomédica del Hospital Universitario Infanta Leonor y Sureste (FIIB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-22
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Age = 18 years at the time of giving informed consent.
2.Subbject 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:
a.Radiological infiltrates on imaging test (conventional radiography, computed tomography (CT) or other)
b.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. = 8 days from symptom onset to randomization.
6.Understands and agrees to comply with planned study procedures.
7.Women of childbearing potential must agree to use at least one medically accepted method of contraception (e.g., barrier contraceptives [condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or intrauterine devices) for the duration of the study.
8.Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1. SpO2 = 91% breathing ambient air or SpO2 < 95% with oxygen in nasal goggles (NG) at 2 bpm (equivalent to PaO2/FiO2 about 300)
2.Patient for whom responsible physician considers the study is not the best medical option, or whom follow-up after discharge will be difficult.
3.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 with immunovirological stability (CD4> 500 and undetectable viral load) for at least 6 months prior to inclusion in this study may be included. Patients on ART regimens with protease inhibitors will be excluded.
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 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
a.History of acute myocardial infarction, acute coronary syndrome (unstable angina, coronary by-pass surgery, angioplasty or coronary stenting) = 6 months prior to randomization
b.Symptomatic heart failure (NYHA grade 2 or greater), 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).

14.Known or suspected active autoimmune disease. Vitiligo, MD type I, residual autoimmune hypothyroidism requiring hormone replacement therapy, psoriasis not requiring systemic treatment, or other previous autoimmune diseases not expected to recur in the absence of precipitating factors, may be included in the study.
15.Pregnancy or lactation, or positive pregnancy test at baseline or screening visit
16.Patients who are expected to be transferred to another facility sooner than 72 hours after inclusion in the study.
17.Patients who have received experimental treatment (off-label, compassionate use or in clinical trials) within 30 days prior to the screening visit, with the exception of treatment considered standard (such as HCQ, AZTR or LOP/r are standard at the time this protocol is drawn up), initiated on admission to hospital, up to 48 hours before inclusion in the study.
18.Patients who have a history of allergic reactions attributed to maraviroc, or any of their components.
19. Treatment with CYP3A4 potent inhibitor or inducer drugs (excluding topical drugs) that cannot be discontinued without harming the patient's health (or risk thereof) and that are not interchangeable with other treatments with a different profile with respect to CYP3A4.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified