Randomized clinical trial to evaluate the efficacy of hydroxychloroquine associated or not with azithromycin as a treatment for COVID-19 infectio

Phase 1

• Conditions: COVID-19 infection; MedDRA version: 20.0Level: PTClassification code 10070255Term: Coronavirus test positiveSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001606-33-ES
• Lead Sponsor: Instituto Investigación Sanitario Biocruces Bizkaia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-07
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 132

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
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62

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

Study & Design

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