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 |
Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006 Nov 8;6:54. Review. — View Citation
Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18. — View Citation
Chesney MA, Ickovics JR, Chambers DB, Gifford AL, Neidig J, Zwickl B, Wu AW. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG). AIDS Care. 2000 Jun;12(3):255-66. — View Citation
Ganyani T, Kremer C, Chen D, Torneri A, Faes C, Wallinga J, Hens N. Estimating the generation interval for coronavirus disease (COVID-19) based on symptom onset data, March 2020. Euro Surveill. 2020 Apr;25(17). doi: 10.2807/1560-7917.ES.2020.25.17.2000257. — View Citation
Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honoré S, Colson P, Chabrière E, La Scola B, Rolain JM, Brouqui P, Raoult D. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20. — View Citation
Kalil AC. Treating COVID-19-Off-Label Drug Use, Compassionate Use, and Randomized Clinical Trials During Pandemics. JAMA. 2020 May 19;323(19):1897-1898. doi: 10.1001/jama.2020.4742. — View Citation
Kimball A, Hatfield KM, Arons M, James A, Taylor J, Spicer K, Bardossy AC, Oakley LP, Tanwar S, Chisty Z, Bell JM, Methner M, Harney J, Jacobs JR, Carlson CM, McLaughlin HP, Stone N, Clark S, Brostrom-Smith C, Page LC, Kay M, Lewis J, Russell D, Hiatt B, Gant J, Duchin JS, Clark TA, Honein MA, Reddy SC, Jernigan JA; Public Health - Seattle & King County; CDC COVID-19 Investigation Team. Asymptomatic and Presymptomatic SARS-CoV-2 Infections in Residents of a Long-Term Care Skilled Nursing Facility - King County, Washington, March 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 3;69(13):377-381. doi: 10.15585/mmwr.mm6913e1. — View Citation
Lauer SA, Grantz KH, Bi Q, Jones FK, Zheng Q, Meredith HR, Azman AS, Reich NG, Lessler J. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med. 2020 May 5;172(9):577-582. doi: 10.7326/M20-0504. Epub 2020 Mar 10. — View Citation
Liu J, Cao R, Xu M, Wang X, Zhang H, Hu H, Li Y, Hu Z, Zhong W, Wang M. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov. 2020 Mar 18;6:16. doi: 10.1038/s41421-020-0156-0. eCollection 2020. — View Citation
McMichael TM, Currie DW, Clark S, Pogosjans S, Kay M, Schwartz NG, Lewis J, Baer A, Kawakami V, Lukoff MD, Ferro J, Brostrom-Smith C, Rea TD, Sayre MR, Riedo FX, Russell D, Hiatt B, Montgomery P, Rao AK, Chow EJ, Tobolowsky F, Hughes MJ, Bardossy AC, Oakley LP, Jacobs JR, Stone ND, Reddy SC, Jernigan JA, Honein MA, Clark TA, Duchin JS; Public Health-Seattle and King County, EvergreenHealth, and CDC COVID-19 Investigation Team. Epidemiology of Covid-19 in a Long-Term Care Facility in King County, Washington. N Engl J Med. 2020 May 21;382(21):2005-2011. doi: 10.1056/NEJMoa2005412. Epub 2020 Mar 27. — View Citation
multicenter collaboration group of Department of Science and Technology of Guangdong Province and Health Commission of Guangdong Province for chloroquine in the treatment of novel coronavirus pneumonia. [Expert consensus on chloroquine phosphate for the treatment of novel coronavirus pneumonia]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Mar 12;43(3):185-188. doi: 10.3760/cma.j.issn.1001-0939.2020.03.009. Chinese. — View Citation
Pagarolas AA, Suñé TP. [Microbiological diagnosis of viral respiratory infections in the adult patient]. Enferm Infecc Microbiol Clin. 2014 Feb;32 Suppl 1:51-6. doi: 10.1016/S0213-005X(14)70150-8. Spanish. — View Citation
Pan Y, Zhang D, Yang P, Poon LLM, Wang Q. Viral load of SARS-CoV-2 in clinical samples. Lancet Infect Dis. 2020 Apr;20(4):411-412. doi: 10.1016/S1473-3099(20)30113-4. Epub 2020 Feb 24. — View Citation
Quagliarello V, Ginter S, Han L, Van Ness P, Allore H, Tinetti M. Modifiable risk factors for nursing home-acquired pneumonia. Clin Infect Dis. 2005 Jan 1;40(1):1-6. Epub 2004 Dec 1. — View Citation
Savarino A, Di Trani L, Donatelli I, Cauda R, Cassone A. New insights into the antiviral effects of chloroquine. Lancet Infect Dis. 2006 Feb;6(2):67-9. — View Citation
Shipman WD, Vernice NA, Demetres M, Jorizzo JL. An update on the use of hydroxychloroquine in cutaneous lupus erythematosus: A systematic review. J Am Acad Dermatol. 2020 Mar;82(3):709-722. doi: 10.1016/j.jaad.2019.07.027. Epub 2019 Jul 13. — View Citation
Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271. doi: 10.1038/s41422-020-0282-0. Epub 2020 Feb 4. — View Citation
Yan Y, Zou Z, Sun Y, Li X, Xu KF, Wei Y, Jin N, Jiang C. Anti-malaria drug chloroquine is highly effective in treating avian influenza A H5N1 virus infection in an animal model. Cell Res. 2013 Feb;23(2):300-2. doi: 10.1038/cr.2012.165. Epub 2012 Dec 4. — View Citation
Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen HL, Peiris M, Wu J. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. doi: 10.1056/NEJMc2001737. Epub 2020 Feb 19. — View Citation
* 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04369456 -
Blood Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients
|
N/A | |
Completed |
NCT04527471 -
Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19
|
Phase 2 | |
Recruiting |
NCT04410510 -
P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19
|
Phase 2/Phase 3 | |
Withdrawn |
NCT04383899 -
Role of Ibuprofen and Other Medicines on Severity of Coronavirus Disease 2019
|
||
Completed |
NCT04542915 -
COVID-19-Related Health and Practices Among Dental Hygienists
|
||
Suspended |
NCT04385771 -
Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation
|
N/A | |
Completed |
NCT04532632 -
Taste and Smell Impairment in Critically Ill COVID-19 Patients
|
||
Terminated |
NCT04954014 -
Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients
|
Phase 2 | |
Terminated |
NCT04530448 -
Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization
|
Phase 4 | |
Completed |
NCT04413435 -
Clinical Characteristics of Critically Ill Patients With COVID-19
|
||
Terminated |
NCT05593770 -
International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response
|
Phase 2/Phase 3 | |
Completed |
NCT04510493 -
Canakinumab in Patients With COVID-19 and Type 2 Diabetes
|
Phase 3 | |
Active, not recruiting |
NCT04587219 -
The Study of "Gam-COVID-Vac" Vaccine Against COVID-19 With the Participation of Volunteers of 60 y.o and Older
|
Phase 2 | |
Withdrawn |
NCT05430958 -
Safety, Tolerability and Immunogenicity of INO-4800 for COVID19 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04596579 -
SARS-CoV-2 (COVID-19) Immune Surveillance Among a Population Based Sample of Adults in Florida
|
||
Completed |
NCT04405934 -
COG-UK Project Hospital-Onset COVID-19 Infections Study
|
N/A | |
Enrolling by invitation |
NCT04484025 -
SPI-1005 Treatment in Moderate COVID-19 Patients
|
Phase 2 | |
Terminated |
NCT04442230 -
NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)
|
Phase 2 | |
Terminated |
NCT04642638 -
Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04527432 -
COVID-19 Health Professional Impact Study
|
N/A |