Efficacy of different treatments in patients infected with COVID-19

Phase 1

• Conditions: Patients infected with COVID19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001156-18-ES
• Lead Sponsor: Fundación para la investigación Biomedica Hospital Universitario La Paz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-03
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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