COVID-19 infection MedDRA version: 20.0 Level: PT Classification code 10070255 Term: Coronavirus test positive System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Ibuprofen
Pharmaceutical Form: Tablet
INN or Proposed INN: IBUPROFEN
CAS Number: 15687-27-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Trade
Sponsors
Instituto Investigación Sanitario Biocruces Bizkaia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients of both sexes - Patients = 18 years with COVID and comorbidities (COPD, asthma, heart disease, HT, diabetes, neoplasia, chronic liver disease or with immunosuppressive treatment), without pneumonia or over 60 with COVID - SARS-CoV-2 infection confirmed by PCR test - Radiographic evidence of not presenting pneumonia - O2 saturation> 92% - Respiratory Rate =65 years) yes F.1.3.1 Number of subjects for this age range 62
Exclusion criteria
Exclusion criteria: - Participation in any other clinical trial with an experimental treatment for COVID-19 - Hypersensitivity to the active substance, to 4-aminoquinoline compounds or to any of the excipients included in section 6.1 of the hydroxychloroquine data sheet - Hypersensitivity to azithromycin, erythromycin, any other macrolide or ketolide antibiotic or to any of the excipients listed in section 6.1 of the azithromycin SmPC - psoriasis - Patients with glucose-6-phosphate dehydrogenase deficiency - Any contraindication according to the Technical Data Sheet of Hydroxychloroquine and Azithromycin - pneumonia - Myasthenia gravis - Pre-existing maculopathy of the eye - Presence of changes in acuity or visual field - QT +/- 450 extension - ALT or AST> 5 x ULN - Creatinine clearance <50 ml / min - Positive pregnancy test - Woman with breastfeeding - Active treatment with: artemeter / lumefantrine, mefloquine, natilizumab, live attenuated virus vaccines, pimecrolimus, tacrolimus (topical), mosifloxacin, and agalsidase alpha and beta - Refusal by the patient to accept the commitment to comply with the procedures indicated during the research process
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the therapeutic effectiveness of Hydroxychloroquine associated with Azithromycin treatment for symptom control and negative viral load, in patients with comorbidities without pneumonia and COVID-19 infection.;Secondary Objective: - Evaluate the safety of the treatment - Assess tolerance of treatment;Primary end point(s): Proportion of patients with negative viral load by CODV-19 [SARS-CoV-2 (PCR)] at 6 days after the start of treatment;Timepoint(s) of evaluation of this end point: 30 DAYS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Sociodemographic data - Clinical data: temperature, FR, SatO2 and FC - Analytical data: biochemistry, hematimetry, LDH, ferritin and dimers - Time until the first normalization of fever (normalization criteria: temperature 98%). - Duration of hospitalization in the Hospitalization Service at Home / Hospital if applicable (days) - Percentage of patients who develop pneumonia - Percentage of patients requiring hospital admission for poor evolution - All-cause mortality on day 28 - Proportion of patients with adverse treatment events leading to withdrawal of drug administration. It is defined as a safety population: those patients who have given their IC, have been randomized and have received at least one dose of study treatment with at least one evaluation and follow-up visit.;Timepoint(s) of evaluation of this end point: 30 DAYS | — |
Countries
Spain
Contacts
Public ContactEpidemiologist
Eunate Arana Arri (Instituto Investigación Biocruces Bizkaia)
Outcome results
None listed