| Eligibility |
First randomization
Inclusion criteria.
- Men and women agree to participate in the study by signing the informed consent.
- Men and women aged = 60 years.
- Men and women aged =18 years <60 years with = 2 comorbidities of the following:
hypertension, obesity, diabetes, cirrhosis, chronic neurological disease, active
cancer, heart failure, ischemic heart disease, COPD.
- Patient with a diagnosis of SARS-CoV-2 infection confirmed by PCR or rapid diagnostic
test prior to randomization.
- Patients with symptoms and signs compatible with active infection.
- Men and women of reproductive capacity must agree to use highly effective
contraceptive methods (diaphragm plus spermicide or male condom plus spermicide, oral
contraceptive combined with a second method of contraceptive implant, injectable
contraceptive, permanent intrauterine device, sexual abstinence or vasectomy) during
your participation in the study and within 30 days of the last visit.
- In addition, women participating in the study with reproductive capacity must have a
negative pregnancy test at the time of inclusion.
Exclusion criteria.
- Patients participating in any other clinical trial with drugs with potential antiviral
action for SARS-CoV-2
- Concomitant treatment with drugs other than the treatments included in this study with
demonstrated or potential action against SARS-CoV-2 in the 24 hours prior to the
administration of the study treatment.
- Patients who are already receiving any of the study drugs.
- Patients treated with corticosteroids at immunosuppressive doses (15 mg / day in the 7
days prior to the onset of symptoms).
- Evidence of multi-organ failure.
- HIV positive, confirmed by rapid test before inclusion.
- Patients who require reservoir, mechanical ventilation or present acute respiratory
distress criteria at the time of inclusion.
- ALT or AST> 5 times the upper limit of normal during screening.
- Creatinine clearance less than 60 ml / min during screening.
- Pregnancy test with positive result during screening.
- Women who are breastfeeding.
- Patients with known hypersensitivity to any of the drugs in the treatment branches of
the study, their metabolites or excipients.
- Patients who receive medication incompatible with the study drugs after reviewing
possible interactions.
- Patients who present any contraindication or condition that is included in the section
on warnings and special precautions for the use of the technical sheets of the drugs
under study (Emtricitabine / Tenofovir disoproxil, and remdesivir) or any other reason
that the research team has criteria is reason. not to be included in the study.
- Subjects who are not able to understand the information sheet and are unable to sign
the informed consent
Second randomization (if applicable):
Patients already included in the study and initially randomized may be re-randomized at any
time if they present an O2 Sat <95% (need for oxygen therapy) and at least 1 marker of
inflammation of the following: IL-6, CRP, D-Dimer , LDH, or ferritin above the upper limit
of the normal range. This randomization can only be done in hospitalized patients. Patients
will receive one of the following arms of treatment:
- Baricitinib and dexamethasone
- Dexamethasone
Exclusion criteria (rescue randomization):
- Non-hospitalized patient
- Being receiving cytotoxic or biological treatments (such as TNF inhibitors, anti
interleukin 1, anti-interleukin 6 (tocilizumab or sarilumab), therapies against B or T
cells (rituximab), interferon or Janus kinase inhibitors.
- Have ever received convalescent plasma or intravenous immunoglobulins.
- Suspicion of suffering from another serious bacterial, fungal or viral infection in
addition to COVID-19 that in the opinion of the researcher could be a risk to receive
the research products.
- Have received a live vaccine 4 weeks before screening
- Require mechanical ventilation or ECMO
- Patient with a history of thromboembolic disease: deep vein thrombosis and / or
pulmonary embolism within 12 weeks prior to randomization or have a history of
recurrent thromboembolic disease
- Neutropenia <1000 cells / µL
- Lymphopenia <200 cells / µL
- GOT or GPT> 5 times the upper limit of normal
- MDRD <30 mL / min
- History of hypersensitivity to baricitinib or its components.
- Pregnant or planning pregnancy or lactating during the study
- Are using or will be using a blood purification instrument to remove pro-inflammatory
cytokines.
- A life expectancy <48 hours from screening.
- Contraindication to take the study medication or investigator criteria.
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