Safety and Efficacy of Maraviroc and/or Favipiravir With Standard Therapy in Severe COVID-19 Adults (COMVIVIR)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, CCR5, Cytokine storm, Maraviroc, Favipiravir, RdRP inhibitors
Eligibility 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) or quick antigen test
- 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.
- With at least two of the following indicators of severity: SpO2 81-90%, PaFi 150-300 mmHg, FiO2>60% , lung damage in thorax radiographic image => 25% as determined by RALE score (an equivalent to 2-4).
- 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
- Oxygen saturation < 70% (ambient)
- Clinical evidence of an infectious disease different from COVID at the time of admission
- Chronic kidney failure
- Coronary disease
- Glomerular filtration rate < 30ml/min/1.73 m2 and known history of preexisting chronic renal failure (Chronic kidney disease stages 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
- Inability to freely decide to participate
- Psychotropics treatment
- Erythromycin treatment
- Polydrug use (Defined as more than two addictions combined)
- With transplant background
- With any autoimmune disorder
- With known hypersensibility to maraviroc and/or favipiravir
- On invasive mechanical ventilation at the time of randomization
Sites / Locations
- Hospital General de México "Dr. Eduardo Liceaga"
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
Currently used therapy (CT) only
Maraviroc+CT
Favipiravir+CT
Maraviroc+Favipiravir+CT
Treatment currently used at Hospital General de México "Dr. Eduardo Liceaga" for non-critical COVID patients: Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present.
Maraviroc AND treatment currently used at Hospital General de México "Dr. Eduardo Liceaga" for non-critical COVID patients.
Favipiravir AND treatment currently used at Hospital General de México "Dr. Eduardo Liceaga" for non-critical COVID patients.
Maraviroc AND Favipiravir AND treatment currently used at Hospital General de México "Dr. Eduardo Liceaga" for non-critical COVID patients