Patients infected with COVID19
Conditions
Interventions
Trade Name: Dolquine 200 mg comprimidos recubiertos.
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Buccal use
Trade Name: azitr
Sponsors
Fundación para la investigación Biomedica Hospital Universitario La Paz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • That you agree to participate in the study by signing the informed consent. • Men and women aged =18 years • Patients admitted with a diagnosis of severe pneumonia due to SARS-CoV-2. • Diagnosis of SARS-CoV-2 infection confirmed by PCR carried out = 4 days prior to randomization. • Onset of symptoms = 4 days. • Basal oxygen saturation = 93%. • Men and women with reproductive capacity should 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 ability must have a negative pregnancy test at enrollment. 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 1000 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients participating in some other clinical trial for SARS-CoV-2 infection. • Concomitant treatment with other drugs 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. • They already receive some of the study drugs. • Evidence of multi-organ failure. • Patients who require mechanical ventilation at the time of inclusion. • Patients who present criteria for acute respiratory distress at the time of inclusion. • ALT or AST> 5 times the upper limit of normal during screening. • Creatinine clearance <50 ml / min during screening. • Pregnancy test with positive result during screening. • Lactating women. • Patients with known hypersensitivity or contraindication to any of the drugs in the study treatment arms, their metabolites or excipients. • Patients who for any reason should not be included in the study according to the evaluation of the research team. • Subjects who are unable to understand the information sheet and unable to sign the informed consent. • Patients who are expected to transfer to another center in the next 96 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Discharge from the patient or death;Timepoint(s) of evaluation of this end point: The main result is all-cause mortality, subdivided by disease severity at the time of randomization.;Main Objective: Provide reliable estimates of the effects of these antiviral treatments on hospital mortality.;Secondary Objective: The secondary objectives are to evaluate the effects of these antiviral treatments on the length of the hospital stay and on the reception of ventilation or intensive care. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The main secondary outcomes are the length of hospital stay and whether the patient received assisted ventilation (or intensive care).;Timepoint(s) of evaluation of this end point: Discharge from the patient or death | — |
Countries
Spain
Contacts
Public ContactAlberto Borobia
Servicio de Farmacología Clínica. Unidad de Ensayos Clínicos (UCICEC)
Outcome results
None listed