Safety and Efficacy of Maraviroc and/or Favipiravir With Standard Therapy in Severe COVID-19 Adults

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2, randomized, open-label study to evaluate the safety and efficacy of maraviroc, favipiravir, and both drugs administered along with currently used therapy in hospitalized patients with pulmonary SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) infection (COVID-19)

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

Details

• Lead Sponsor: Hospital General de México Dr. Eduardo Liceaga
• Collaborators: CCINSHAE. Secretaría de Salud. México; Centro de Investigación en. Enfermedades Infecciosas, Mexico; Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Treatments: Favipiravir; Maraviroc

Criteria

Inclusion Criteria:

• With severe non-critical stage of COVID at the time of admission.

• Patients tested positive for SARS-CoV-2 confirmed by PCR (Polymerase Chain Reaction)

• Within the first 12 days post appearance of symptoms

• With at least one of the following risk factors: Diabetes mellitus (DM), obesity (BMI>30, hypertension, age > 65 years.

• Respiratory rate 25-34/min and no signs of respiratory distress.

• Thorax USG with LUS (Lung Ultrasonographic Score)>23

• With at least two of the following indicators of severity: SpO2 81-90%, PaFi 250-100 mmHg, FiO2>60% , LHD (Lactic Acid Dehydrogenase) >350 U/L, lung infiltration >50% determined by thorax radiography.

• Normal liver function (Considered up to a fivefold increase above the normal limits of hepatic transaminases)

• Signed informed consent

Exclusion Criteria:

• Pregnant or lactating women

• Patients already participating in another clinical study

• Clinical evidence of an infectious disease different from COVID at the time of admission

• Signs of respiratory distress

• Chronic kidney failure

• Coronary disease

• Glasgow score < 13

• Glomerular filtration rate < 60ml/min/1.73 m2 and known history of preexisting chronic renal failure (Chronic kidney disease stages 3,4,5)

• Known history of HCV, HBV and/or clinical signs of hepatic liver failure.

• Any type of cancer

• HIV and/or any anti retroviral treatment

• Psychotropics treatment

• With transplant background

• With any autoimmune disorder

• With known hypersensibility to maraviroc and/or favipiravir