COVID-19 MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: DOLQUINE
Product Name: Hydroxychloroquine
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydroxychloroquine
CAS Number: 118-42-3
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
FIMABIS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For residents: 1. Institutionalized people in residences since the beginning of the COVID19 epidemic who do not have the infection present at the time of entering the study. In this regard, prior to the first day of evaluation of each residence, a census will be made of residents and professionals who have already had COVID19 verified by RT-PCR. If the last resident or professional has had the disease for more than 15 days, the residence will be excluded from the study. Once the residence was included (because the presence of residents and / or workers exposed to COVID19 has been confirmed less than 15 days ago), the decision to enter the study of each participating subject will be made only by confirmation by baseline RT-PCR, in accordance with the SEIMC recommendations on the use of antibody detection tests in nursing homes21. In addition, until the PCR is available, the decision to enter the study will be delayed. 2. That they give their consent to participate in the study or that it be obtained from their legal representative / guardian (see section on informed consent). For professionals: 3. Healthcare professionals who do not have the infection present at the time of entering the study, who provide direct care (AUXILIARY and nurses) to institutionalized elderly with confirmed infection of COVID19 in the last 15 days by means of RT-PCR tests (verification the census of professionals and residents who have had the disease is explained in the previous paragraph). Each included professional will previously undergo RT-PCR tests to verify that they do not have the infection and are asymptomatic carriers. 4. That they give their consent to participate in the study and will not leave their job during the study follow-up for work reasons (unemployment, job change, etc.). 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 1930 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1930
Exclusion criteria
Exclusion criteria: a) Staff members who do not provide direct care to residents. b) Residents with present or past SARS-CoV-2 infection, or with symptoms compatible with COVID19. c) Staff members with present or past SARS-CoV-2 infection, or with symptoms compatible with COVID19. d) Alterations of the QT interval or arrhythmias of any etiology. It will be verified by ECG and telematic transmission to the reference internist. e) Presence of retinopathy of any etiology, changes in acuity or visual field. f) Severe hearing loss (requires the use of hearing aids). g) Structural heart disease. h) History of non-structural heart failure, ischemic heart disease, SCASEST or SCACEST i) Chronic liver disease. j) Alcoholism. k) Epilepsy. l) For the participating professionals, pregnancy or suspected pregnancy (if they are planning pregnancy, or in fertilizer treatment, they must abandon the study). m) Subjects with known HDQ hypersensitivity. n) Subjects diagnosed with G6PDH deficiency. o) Consumption of other medicines that prolong the QT: domperidone, ondansetron, cilostazol, antiarrhythmics (procainamide, amiodarone, flecainide, sotalol), macrolides (azithromycin, clarithromycin, erythromycin), quinolones (ciprofloxacin, levofloxacin), , neuroleptics (haloperidol, chlorpromazine, pimozide), antidepressants (citalopram, escitalopram), sulpiride, anticholinesterase drugs (donepezil). The possibility of withdrawal of any drug that could compromise the pharmacological management of psychotic disorders in older people with treatment of COVID infection19 will be evaluated using the criteria of the Consensus of Spanish Medical Societies the safety of co-administering HCQ and deciding on inclusion in the study. This process will be managed by the reference internists participating in the study. p) Waiver to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effectiveness of prophylactic administration of hydroxychloroquine in the staff who provide direct care and in institutionalized people, on the incidence of secondary cases of SARS-CoV-2 infection in residents and professionals in the 4 weeks after the start of the trial. The effects on reduction in mortality and hospital admissions, incidence of symptoms, and drug safety will also be evaluated. Likewise, it will be evaluated whether the weekly review of some aspects of infection prevention (staff knowledge of protective measures, cross infection circuits, etc) interacts with hydroxychloroquine chemoprophylaxis.;Secondary Objective: a) Determine the possible impact on the mortality of residents at 14 and 28 days. b) Know the compliance of the treatment in the professionals included in the treatment. c) Examine the incidence of typical symptoms of SARS-CoV-2 infection: fever, cough, headache, arthromyalgia, pharyngeal pain, dyspnea, diarrhea, vomiting, abdominal pain, anosmia. d) Compare the incidence of hospital admissions of staff and residents who contract SARS-CoV-2 infection during the study. e) Evaluate the safety of the administered chemoprophylactic regimen. f) Study the proportion of subjects who drop out of the study for any reason. g) Analyze the proportion of subjects who do not adhere to chemoprophylaxis.;Primary end point(s): To evaluate the effectiveness of prophylactic administration of hydroxychloroquine in the staff who provide direct care and in institutionalized people, on the incidence of secondary cases of SARS-CoV-2 infection in residents and professionals in the 4 weeks after the start of the trial. The effects on reduction in mortality and hospital admissions, incidence of symptoms, and drug safety will also be evaluated. Likewise, it will be evaluated whether the weekly review of some aspects of infection prevention (staff knowledge of protective measures, cross infection circuits, etc) interacts with hydroxyc | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Determine the possible impact on the mortality of residents at 14 and 28 days. b) Know the compliance of the treatment in the professionals included in the treatment. c) Examine the incidence of typical symptoms of SARS-CoV-2 infection: fever, cough, headache, arthromyalgia, pharyngeal pain, dyspnea, diarrhea, vomiting, abdominal pain, anosmia. d) Compare the incidence of hospital admissions of staff and residents who contract SARS-CoV-2 infection during the study. e) Evaluate the safety of the administered chemoprophylactic regimen. f) Study the proportion of subjects who drop out of the study for any reason. g) Analyze the proportion of subjects who do not adhere to chemoprophylaxis.;Timepoint(s) of evaluation of this end point: Days: 6, 14 and 28 | — |
Countries
Spain
Contacts
Public ContactGloria Luque
FIMABIS
Outcome results
None listed