EUCTR2020-001606-33-ES
Active, not recruiting
Phase 1
Randomized clinical trial to evaluate the efficacy of hydroxychloroquine associated or not with azithromycin as a treatment for COVID-19 infection. - Randomized clinical trial to evaluate the efficacy of a treatment for COVID-19 infection
Instituto Investigación Sanitario Biocruces Bizkaia0 sites132 target enrollmentApril 7, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19 infection
- Sponsor
- Instituto Investigación Sanitario Biocruces Bizkaia
- Enrollment
- 132
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<20 rpm
- •\- Willing and able to sign the written informed consent before carrying out the study procedures. Exceptionally, oral consent is admitted, preferably before independent witnesses, documenting it in the medical record and provided that it can later be ratified.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
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
Outcomes
Primary Outcomes
Not specified
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