SARS-CoV-2 infection in high-risk contacts
Conditions
Interventions
Trade Name: CIRCADIN 2 mg
Product Name: CIRCADIN 2mg
Product Code: EMEA/H/C/000695
Pharmaceutical Form: Tablet
INN or Proposed INN: CIRCADIN
CAS Number: 73-31-4
Other descriptive name: MELATONIN
Conce
Sponsors
Fundación para la Investigación Biomédica del Hospital La Paz (FIBHULP)
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 16 weeks;Main Objective: The main objective is to evaluate the efficacy of melatonin in the prevention of SARS-CoV-2 infection in healthcare personnel with high-risk contacts.;Primary end point(s): Number of symptomatic infections confirmed by SARS-CoV-2 (COVID-19);Secondary Objective: o Evaluate the efficacy of melatonin in the prevention of asymptomatic SARS-CoV-2 infections (COVID-19). o To evaluate the efficacy of melatonin in preventing the development of severe COVID-19 in participants who acquire the infection during the development of the study. o Assess the duration of symptoms of COVID-19 infection in participants receiving melatonin. o Assess IgM / IgG seroconversion from symptom detection | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 16 weeks;Secondary end point(s): • Number of asymptomatic infections confirmed by SARS-CoV-2 (COVID-19) measured by serology. • Severity of SARS-CoV-2 (COVID-19) infection measured in relation to the following: o Asymptomatic o Mild symptoms defined as general malaise, fever, cough, arthromyalgia o Moderate symptoms. The above plus moderate respiratory distress requiring hospital admission. o Serious symptoms. The above plus frank respiratory distress requiring ICU measures • Duration of symptoms of COVID-19 coronavirus infection measured in days. o Fever, myalgia, asthenia, respiratory distress • Relationship between the duration in days of treatment and the appearance of symptoms. • Relationship between the duration in days of treatment and the duration of symptoms. • Assess IgM / IgG seroconversion from symptom detection. • Time to positive PCR for SARS-CoV-2 • Time (days) until appearance of symptoms compatible with COVID-19. In those participants who throughout the study show positive PCR for SARSCoV: • Need for hospital admission • Duration in days of hospital stay. • Time (days) until hospital discharge or until obtaining a score on the NEWS scale (Annex 1) =2 maintained for 24 hours, whichever occurs earlier. • Difference in the score on the NEWS scale between day 1 and days 3, 5, 8, 11, 15 and 29 of admission. • Percentage of participants requiring oxygen therapy. • Percentage of participants requiring non-invasive mechanical ventilation • Percentage of participants requiring invasive mechanical ventilation. • Percentage of participants requiring intensive care. • Average stay in ICU (days) • Mortality from any cause. • Progression to severe COVID (any of the following): 1) Radiological progression OR 2) Needs for ventilatory support 3) Syndrome of acute respiratory distress. 4) Admission to UVI, or 5) Death due to COVID-19. Other variables of interest: • Percentage of men and women with PCR positivity for SARS- | — |
Countries
Spain
Contacts
Public ContactAlberto Borobia
Fundación para la Investigación Biomédica del Hospital La Paz (FIBHULP)
Outcome results
None listed