Clinical trial to avoid infection by SARS-CoV-2 in high-risk population. COVID-19

Phase 1

• Conditions: SARS-CoV-2 infection in high-risk contacts; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001530-35-ES
• Lead Sponsor: Fundación para la Investigación Biomédica del Hospital La Paz (FIBHULP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-13
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

· Men and women aged between 18 and 65 years.
· They are part of the health personnel of public or private hospitals of the Spanish hospital network in an area with risk of transmission of SARS-CoV-2.
· Not having been previously diagnosed with SARS-CoV-2 (COVID-19) infection.
· Have not exhibited symptoms consistent with SARS-CoV-2 (COVID-19) infection from March 1, 2020 until entry into the trial.
· Understand the purpose of the study and have NOT taken any medications such as PrEP against SARS-CoV-2 from March 1, 2020 until trial entry (also includes PrEP for HIV).
· Have a negative PCR for SARS-CoV-2 at the entrance.
Negative urine pregnancy test performed in the 7 days prior to the start of study treatment in pre-menopausal women or <2 years after menopause.
· Women of childbearing potential and men of childbearing potential should commit to using a highly effective method of contraception (such as surgical sterilization, double barrier method, oral contraceptives or hormonal contraceptive implants) and to continue using them until the day of the last dose. of treatment.
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 450
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• HIV infection.
• Active infection with hepatitis B virus.
• Kidney failure (creatinine clearance <60 ml / min / 1.72 m2) and participants on hemodialysis.
• Osteoporosis.
• Myasthenia gravis.
• Pre-existing maculopathy of the eye.
• Retinitis pigmentosa.
• Bradycardia <50 beats / minute.
• Weight <40 Kg.
• Participants with immunosuppressive or hematological disease.
• Treatment in the last month before randomization and for more than 7 days, with drugs that can prolong the QT interval including: azithromycin, chlorpromazine, cisapride, clarithromycin, domperidone, droperidol, erythromycin, halofantrine, haloperidol, lumefantrine, mefloquine, methadone , pentamidine, procaine quinidine, quinine, sotalol, sparfloxacin, thioridazine, amiodarone.
• Participants with hereditary galactose intolerance, Lapp lactase deficiency, or glucose or galactose malabsorption.
• Fluvoxamine treatment.
• Treatment with benzodiazepines or non-benzodiazepine hypnotics, such as zaleplon, zolpidem, and zopiclone.
• Pregnancy or planning to become pregnant during the course of the study. Lactation
• Participants with a history of potentially immune-mediated or inflammatory diseases: systemic lupus erythematosus, Crohn's, ulcerative colitis, vasculitis, rheumatoid arthritis.
• Hypersensitivity to the active substance or to any of the excipients.
• Paarticipants who for any reason should not be included in the study according to the evaluation of the research team.

Study & Design

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