EUCTR2020-001156-18-ESActive, not recruitingPhase 1
Randomized clinical trial to evaluate the efficacy of different treatments in patients with COVID-19 who require hospitalization - PanCOVID19
Fundación para la investigación Biomedica Hospital Universitario La Paz0 sites1,000 target enrollmentStarted: April 3, 2020Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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.
Investigators
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