Prevention of COVID19 Infection in Nursing Homes by Chemoprophylaxis With Hydroxychloroquine (PREVICHARM)

NCT04400019 | Unknown Phase 2 DMC

• 1 other identifier: COV20/00565
• Study Type: interventional
• Target: 1,930
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sars-CoV2; Coronavirus Infection; Prevention & Control; Nursing Home; Hydroxychloroquine

Keywords

clinical trial; Hydroxychloroquine; chemoprophylaxis; Sars-CoV2; COVID-19

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (9)

• Mortality

  This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

• Compliance with treatment

  It will be evaluated during the five days that the chemoprophylaxis with hydorxychloroquine is administered

• Symptoms of SARS-CoV-2 infection at six days

  This outcome will be evaluated at 6 days from the administration of chemoprophylaxis with hydroxychloroquine

• Symptoms of SARS-CoV-2 infection at 14 days

  This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

• Symptoms of SARS-CoV-2 infection at 28 days

  This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Study Arms (2)

Tracking control

NO INTERVENTION

According to the randomization process described, those nursing homes assigned to the control arm of the trial will receive the same treatment as those assigned to the intervention group, except for the medication, which will be a masked placebo. The study is triple blind, so neither the professionals who carry out the follow-up, nor the patients, nor the person in charge of analyzing the data, know to which group each nursing home belongs.

Intervention

EXPERIMENTAL

The dose to be used as chemoprophylaxis will be 800mg of Hydroxychloroquine (HCQ) on the first day and 400mg during the subsequent four days. Participating subjects will be followed up at 6, 14 and 28 days.

Drug: Hydroxychloroquine Only Product in Oral Dose Form

Interventions

Hydroxychloroquine Only Product in Oral Dose Form DRUG

The dose to be used as chemoprophylaxis will be 800mg of HCQ on the first day and 400mg for the following four days.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Malaga: lead
• Instituto de Investigacion Biomedica de Malaga: collaborator
• Carlos III Health Institute: collaborator

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Related Links

• Sociedad Española de Geriatría y Gerontología. Colaboración servicios de geriatría hospitalarios - hospitales de media estancia - residencias de mayores y centros sociosanitarios. 2020
• Mitja O. Antiviral Treatment of COVID-19 Confirmed Cases and Ring Chloroquine Chemoprevention in Close Contacts: a Cluster Randomized Clinical Trial. 2020 \[cited 2020 Mar 22\]. (Clinical Trials.gov). Report No.: NCT04304053.

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• José M Morales-Asencio, PhD

  University of Malaga; Malaga, Spain.

  PRINCIPAL INVESTIGATOR

• Ricardo Gómez-Huelgas, PhD

  Hospital Regional de Malaga

  PRINCIPAL INVESTIGATOR

• Juan C Morilla-Herrera, PhD

  Distrito de Atención Primaria Málaga-Valle del Guadalhorce

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José M Morales-Asencio, Professor

CONTACT

+34 629 77 68 95; jmmasen@uma.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The HCQ and the placebo will be manufactured by Laboratorios Rubio, blinded in similar containers for HCQ and placebo and will be stored in the pharmacy of the participating reference hospitals and will be distributed to the participating residences by the research technicians hired for the project. A record of doses delivered and monitoring of doses consumed will be carried out. The containers must be wrapped in a disposable protective cover, which can be removed before entering the residences, in order to minimize the accidental transmission of the virus through this route.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Research Methods and Evidence Based Health Care at University of Málaga (Spain)

Model Details: Controlled, randomized, triple-blind cluster study.

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 22, 2020
• Study Start: September 1, 2020
• Primary Completion: December 15, 2020
• Study Completion: April 1, 2021
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share