Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04400019
Recruitment Status : Not yet recruiting
First Posted : May 25, 2020
Last Update Posted : May 25, 2020
Sponsor:
Collaborators:
Instituto de Investigacion Biomedica de Malaga
Carlos III Health Institute
Information provided by (Responsible Party):
JOSE MIGUEL MORALES ASENCIO, University of Malaga

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.


Condition or disease Intervention/treatment Phase
Sars-CoV2 Coronavirus Infection Prevention & Control Nursing Home Hydroxychloroquine Drug: Hydroxychloroquine Only Product in Oral Dose Form Phase 2 Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1930 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Cluster, randomized controlled stepped-wedge study. The stepped-wedge design involves the collection of observations during a baseline period in which no clusters are exposed to the intervention though they will be receiving placebo. Following this, at regular intervals, a group of clusters will be randomized to receive the intervention, being all participants measured regularly. This process continues until all the clusters have received the intervention.

Thie trial has a pragmatic approach under real clinical practice conditions, which allows the sequential inclusion of subjects in established periods of time in which, in the end, all the subjects of the participating clusters will receive the intervention.

Furthermore, this design allows additional analysis such as modeling the effect of time on the effectiveness of the intervention developed.

Masking: Double (Participant, Outcomes Assessor)
Masking Description: During the period in which the clusters are in the control phase, they will be administered a placebo with the same aspect of the drug. For this reason and because they are measured regularly, they will not be aware of when they enter the intervention phase.
Primary Purpose: Prevention
Official Title: Prevention of COVID19 Infection by the Administration of Hydroxychloroquine to Institutionalized Older People and Nursing Home Staff. A Cluster Randomized Controlled Stepped-wedge Trial (PREVICHARM Study)
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : April 1, 2021


Arm Intervention/treatment
No Intervention: Tracking control

All participating residences (clusters) act as a baseline control, in which the baseline data from the study will be collected from the participating staff and patients, once informed consent has been requested and acceptance has been obtained.

When, as established by the randomization process, the clusters begin to receive the treatment, they will advance to the intervention phase of the trial.

Professionals and residents of the nursing homes that are in the control group phase will receive a placebo, and they will be evaluated by a nasopharyngeal smears for RT-PCR at the start of the study and another one in a weekly basis until they become an intervention group. Once they are in the intervention phase, they will be evaluated according to the procedure for the intervention group.

Participating subjects will be followed up at 6, 14 and 28 days.

Experimental: Intervention
The dose to be used as chemoprophylaxis will be 800mg of Hydroxychloroquine (HCQ) on the first day and 400mg during the fsubsequent four days. Participating subjects will be followed up at 6, 14 and 28 days.
Drug: Hydroxychloroquine Only Product in Oral Dose Form
The dose to be used as chemoprophylaxis will be 800mg of HCQ on the first day and 400mg for the following four days.




Primary Outcome Measures :
  1. Number of secondary cases of SARS-CoV2 infection among residents at six days [ Time Frame: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine ]
    Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.

  2. Number of secondary cases of SARS-CoV2 infection among residents at 14 days [ Time Frame: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine ]
    Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.

  3. Number of secondary cases of SARS-CoV2 infection among residents at 28 days [ Time Frame: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine ]
    Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.

  4. SARS-CoV-2 infection in nursing home staff who provide direct care at six days [ Time Frame: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine ]
    Dichotomous categorical variable

  5. SARS-CoV-2 infection in nursing home staff who provide direct care at 14 days [ Time Frame: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine ]
    Dichotomous categorical variable

  6. SARS-CoV-2 infection in nursing home staff who provide direct care at 28 days [ Time Frame: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine ]
    Dichotomous categorical variable


Secondary Outcome Measures :
  1. Mortality [ Time Frame: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine ]
    Dichotomous qualitative variable (1: Death 0: Survival)

  2. Compliance with treatment [ Time Frame: It will be evaluated during the five days that the chemoprophylaxis with hydorxychloroquine is administered ]
    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

  3. Symptoms of SARS-CoV-2 infection at six days [ Time Frame: This outcome will be evaluated at 6 days from the administration of chemoprophylaxis with hydroxychloroquine ]
    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.

  4. Symptoms of SARS-CoV-2 infection at 14 days [ Time Frame: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine ]
    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.

  5. Symptoms of SARS-CoV-2 infection at 28 days [ Time Frame: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine ]
    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.

  6. Hospitalization [ Time Frame: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine ]
    Dichotomous categorical variable. Participant requires hospital admission attributable to SARS-CoV-2 infection

  7. Adverse events at six days [ Time Frame: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine ]
    Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors

  8. Adverse events at 14 days [ Time Frame: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine ]
    Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors

  9. Adverse events at 28 days [ Time Frame: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine ]
    Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 two weeks.
  • 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.
  • NUrsing homes without SARS-CoV-2 infection during the past two weeks.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400019


Contacts
Layout table for location contacts
Contact: José M Morales-Asencio, Professor +34 629 77 68 95 jmmasen@uma.es

Sponsors and Collaborators
University of Malaga
Instituto de Investigacion Biomedica de Malaga
Carlos III Health Institute
Investigators
Layout table for investigator information
Principal Investigator: José M Morales-Asencio, PhD University of Malaga; Malaga, Spain.
Principal Investigator: Ricardo Gómez-Huelgas, PhD Hospital Regional Universitario de Málaga
Principal Investigator: Juan C Morilla-Herrera, PhD Distrito de Atención Primaria Málaga-Valle del Guadalhorce

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: JOSE MIGUEL MORALES ASENCIO, Professor of Research Methods and Evidence Based Health Care at University of Málaga (Spain), University of Malaga
ClinicalTrials.gov Identifier: NCT04400019    
Other Study ID Numbers: COV20/00565
First Posted: May 25, 2020    Key Record Dates
Last Update Posted: May 25, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by JOSE MIGUEL MORALES ASENCIO, University of Malaga:
clinical trial (stepped wedge)
Hydroxychloroquine
chemoprophylaxis
Sars-CoV2
COVID-19
Additional relevant MeSH terms:
Layout table for MeSH terms
Hydroxychloroquine
Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents