EUCTR2020-001530-35-ES
Active, not recruiting
Phase 1
Randomized multicenter clinical trial to evaluate the efficacy of melatonin in the prophylaxis of SARS-CoV-2 infection in high-risk contacts. COVID-19
Fundación para la Investigación Biomédica del Hospital La Paz (FIBHULP)0 sites450 target enrollmentApril 13, 2020
DrugsCIRCADIN 2 mg
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fundación para la Investigación Biomédica del Hospital La Paz (FIBHULP)
- Enrollment
- 450
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
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.
Outcomes
Primary Outcomes
Not specified
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