Coronavirus Infection Clinical Trial
— PREVICHARMOfficial title:
Prevention of COVID19 Infection by the Administration of Hydroxychloroquine to Institutionalized Older People and Nursing Home Staff. Controlled Clinical Trial, Randomized Triple Blind by Clusters (PREVICHARM Study)
Professionals and residents of nursing homes are one of the most vulnerable groups in this
public health crisis of COVID-19, since they have the highest rate of positives for COVID-19,
despite the restriction measures carried out, such as prohibition of family visits to these
centers, the infection occurs by cross transmission with the care staff of the centers, or
with other residents.
At the moment, there are no clinical trials to test the hypothesis that hydroxychloroquine is
effective in coronavirus treatment. Although what has been observed is a better prognosis in
infected patients, since this drug inhibits the replication of the virus and its expansion to
other tissues.
This study is a clinical trial to test the effectiveness of hydroxychloroquine as a
preventive drug for SARS-CoV-2 infection. This drug will be applied to 1050 people residing
in nursing home care and 880 professionals who work in close contact with these people and
who have not yet contracted the infection.
This project will be carried out in the territories of Madrid, Navarra, Aragon and Andalusia
(Spain).
Hydroxychloroquine is a widely known drug that is used in two scenarios, against autoimmune
diseases, such as lupus or rheumatoid arthritis, and as an antimalarial drug.
It is also intended to demonstrate that the presumed reduction in viral load that would be
obtained with hydroxychloroquine prophylaxis, would have no effect in development of immunity
against the virus. This fact can create a new paradigm for the de-escalation of the
confinement to which the population has been subjected to stop the virus spread, allowing the
development of general immunity in controlled populations until reaching total immunity.
In addition to testing the effect of this drug, a non-pharmacological intervention based on a
safety record will be tested in the management of infection on nursing home, to assess its
effectiveness in detecting risk areas or bad practices carried out in this vulnerable
environment.
The study is led by researchers of the Institute of Biomedicine of Malaga (Spain), and has
obtained a financing of 1,024,199 euros from Carlos III Health Institute (Spain).
The period of execution of the clinical trial is one year, and with this intervention, the
intention is to reduce cross-infection in residents by a minimum threshold of 15%, as well as
to decrease infection in the professionals.
Status | Not yet recruiting |
Enrollment | 1930 |
Est. completion date | April 1, 2021 |
Est. primary completion date | December 15, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Institutionalized people in nurswing homes since the beginning of the COVID19 epidemic who do not have the infection present at the time of entering into the study. - Healthcare professionals who provide direct care (nursing assistants and registered nurses) to institutionalized older people in nursing homes with confirmed cases of COVID19 during the past 8 days. - Subjects that give their consent to participate in the study or that it be obtained from their representative / legal guardian. Exclusion Criteria: - Staff members who do not provide direct care to residents. - Residents with active SARS-CoV-2 infection present, or with symptoms compatible with COVID19 confirmed by PCR test. - Staff members with present or past SARS-CoV-2 infection, or with PCR-confirmed symptoms consistent with COVID19. - History of QT interval prolongation or arrhythmias of any etiology. - Presence of retinopathy of any etiology, changes in acuity or visual field. - Severe hearing loss (requires the use of hearing aids). - Structural heart disease. - History of non-structural heart failure, ischemic heart disease, SCASEST, or SCACEST - Chronic liver disease. - Alcoholism. - Epilepsy. - For the participating professionals, pregnancy or suspected pregnancy (if they are planning pregnancy, or in fertilizer treatment, they must abandon the study). - Subjects with known HDQ hypersensitivity. - Subjects diagnosed with G6PDH deficiency. - Taking other medicines that prolong QT: domperidone, ondansetron, cilostazol, antiarrhythmics (procainamide, amiodarone, flecainide, sotalol), macrolides (azithromycin, clarithromycin, erythromycin), quinolones (ciprofloxacin,), moxofloxacin,) neuroleptics (haloperidol, chlorpromazine, pimozide), antidepressants (citalopram, escitalopram), sulpiride, anticholinesterase drugs (donepezil) - Denial to participate in the study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Malaga | Carlos III Health Institute, Instituto de Investigacion Biomedica de Malaga |
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of secondary cases of SARS-CoV2 infection among residents at six days | Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected. | This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine | |
Primary | Number of secondary cases of SARS-CoV2 infection among residents at 14 days | Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected. | This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine | |
Primary | Number of secondary cases of SARS-CoV2 infection among residents at 28 days | Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected. | This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine | |
Primary | SARS-CoV-2 infection in nursing home staff who provide direct care at six days | Dichotomous categorical variable | This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine | |
Primary | SARS-CoV-2 infection in nursing home staff who provide direct care at 14 days | Dichotomous categorical variable | This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine | |
Primary | SARS-CoV-2 infection in nursing home staff who provide direct care at 28 days | Dichotomous categorical variable | This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine | |
Secondary | Mortality | Dichotomous qualitative variable (1: Death 0: Survival) | This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine | |
Secondary | Compliance with treatment | Continous variable. It will be evaluated with the AIDS Clinical Trials Group method: investigation of medications not taken in a period of 4 days prior to the interview)% adherence = (total prescribed galenic units for that period-total units not taken) / total prescribed galenic units for that period | It will be evaluated during the five days that the chemoprophylaxis with hydorxychloroquine is administered | |
Secondary | Symptoms of SARS-CoV-2 infection at six days | Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough. | This outcome will be evaluated at 6 days from the administration of chemoprophylaxis with hydroxychloroquine | |
Secondary | Symptoms of SARS-CoV-2 infection at 14 days | Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough. | This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine | |
Secondary | Symptoms of SARS-CoV-2 infection at 28 days | Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough. | This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine | |
Secondary | Hospitalization | Dichotomous categorical variable. Participant requires hospital admission attributable to SARS-CoV-2 infection | This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine | |
Secondary | Adverse events at six days | Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors | This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine | |
Secondary | Adverse events at 14 days | Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors | This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine | |
Secondary | Adverse events at 28 days | Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors | This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine |
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