- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04354597
Hydroxychloroquine and Azithromycin as Prophylaxis for Healthcare Workers Dealing With COVID19 Patients (MOPHYDA)
A Multicenter, Open-label, Pilot Study on Using Hydroxychloroquine (HCQ) and Azithromycin (AZ) Prophylaxis for Healthcare Workers With a Potential Risk of Exposure to COVID-19 Patients
Studieoversigt
Detaljeret beskrivelse
Exceptional efforts have been paid globally to apply the latest and most effective means of universal standard precautions throughout the settings facing COVID-19 crisis, and this is led by health care providers who are more vulnerable and have a higher risk of getting the infection (8.3% in Italy) and a higher rate of complications and mortality with some reports suggesting high mortality among these individuals.
While several clinical trials are underway across the globe to examine the effect of chloroquine at the moment, the number of COVID-19 cases is still on the rise and health care workers are facing a very high risk of getting the infection. In this study, we aim to study prophylactic efficacy of the combination (HCQ and AZ) among health care professionals in a 16 weeks period.
Undersøgelsestype
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Amman, Jordan
- King Hussein Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Medical doctors, Nurses and Respiratory therapists caring for COVID-19 patients in ER and ICU and dedicated COVID19 units.
- Age between 18 and 70 years old.
- Male or non-pregnant, non- lactating female.
- Availability for follow up by phone.
- Willing to participate and provide signed informed consent.
Exclusion Criteria:
- Subjects with a history of retinopathy, sickle cell disease or trait, psoriasis, or porphyria.
- Subjects who take certain prescribed or over the counter (OTC) concomitant medication including ampicillin, cimetidine, digoxin, statins, cyclosporine, warfarin, fluconazole, within 2 weeks of dosing start, and during the duration of the study.
- Current Symptoms of Fever, Cough, or Shortness of Breath.
- PCR confirmed positive test of COVID-19.
- Weight < 40 kg.
- Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female at the screening.
- Allergy to any of the study medications.
- History of splenectomy.
- Infection with hepatitis B or C viruses.
- Chronic or active neurologic disease including seizure disorder and chronic migraine headaches.
Any abnormal baseline laboratory screening tests listed below
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)above twice the upper limit of normal for the reference lab.
- Creatinine above the normal range.
- Hemoglobin for males <12.5 g/dl and females <10.5 g/dl.
- Platelet count of <150 X 103/L.
- Total white blood cell (WBC) count out of normal range Note: If screening lab values are out of the normal range but are expected to be temporary (e.g. due to dehydration), they may be re-assessed one more time at the discretion of the investigator.
- An abnormal baseline screening ECG suggestive of cardiac disease as determined by a clinical investigator. QTcF of >450 msec for males and >470 msec for females.
- Any other significant finding that based on the judgment of the PI would increase the risk of having an adverse outcome from participating in this study
- Subjects known to have a mental illness
- Subjects who have Skin disorders (including rash, dermatitis, and psoriasis)
- Hematological disease.
- Cardiovascular disease.
- G6PD deficiency.
- Lactose intolerance.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Study Arm A (HCQ & AZ)
Subjects will receive weekly HCQ 400mg X 1 Day PO and AZ 500mg PO X 3 Days; weekly for 16 weeks.
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Subjects will receive weekly HCQ 400mg PO and AZ PO 500mg X 3 Days; weekly for 16 weeks.
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Ingen indgriben: Study Arm B (No treatment)
Subjects will receive no treatment in this group and will be serving as control.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Effect of HCQ and AZ in preventing infection with COVID-19 among healthcare workers working with COVID-19 patients
Tidsramme: 4 Months
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Compare the proportion of participants who have RT-PCR confirmed infection with SARS-CoV-2 in both arms during the study period, measured by negative PCR test for SARS COV-2 virus
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4 Months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Safety of HCQ and AZ
Tidsramme: 4 Months
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Solicited and unsolicited adverse events in participants receiving HCQ+AZ during the study period, measured by the incidence of AEs in both arms.
(The difference in type, number, and intensity)
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4 Months
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Oxygen requirement
Tidsramme: 4 Months
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The proportion of participants who require oxygen therapy for any indication during the study period in both arms, measured by the requirement for O2 or not in both arms.
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4 Months
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ICU admission
Tidsramme: 4 Months
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The proportion of participants who need ICU admission for any reason during the study period in both arms, measured by the incidence of ICU admission in both arms.
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4 Months
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Mortality rate
Tidsramme: 4 Months
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The proportion of participants who die of any cause during the study period in both arms, measured by the incidence of death in both arms.
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4 Months
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20 KHCC 67
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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Kliniske forsøg med COVID-19
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PfizerAktiv, ikke rekrutterendeCOVID-19 | Coronavirus sygdom 2019 (COVID-19) | Covid-19-infektion | Vacciner mod covid-19 | SARS-CoV-2-infektion, COVID19 | COVID-19-vaccination | SARS-CoV-2-infektion, COVID-19 | COVID-19 (Coronavirus sygdom 2019) | COVID-19 SARS-CoV-2-infektionForenede Stater
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PfizerRekrutteringLuftvejssygdomme | COVID-19 | Lungebetændelse | Lungesygdomme | Coronavirussygdom 2019 | Coronavirus sygdom 2019 (COVID-19) | Covid-19-infektion | Øvre luftvejsinfektioner | Luftvejsinfektion | COVID-19 (Coronavirus sygdom 2019) | COVID-19 SARS-CoV-2-infektionBelgien
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Shanghai Public Health Clinical CenterIkke rekrutterer endnu
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Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Afsluttet
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Eggensberger OHGBavarian Health and Food Safety Authority (LGL)RekrutteringTilstand efter COVID-19 | Efter COVID-19 | Post COVID-19 syndrom | Langt COVID-19 syndrom | Post COVID-19 tilstand (PCC)Tyskland
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Yang I. PachankisAktiv, ikke rekrutterendeCOVID-19 luftvejsinfektion | COVID-19 stresssyndrom | COVID-19-vaccinebivirkning | COVID-19-associeret tromboembolisme | COVID-19 Post-Intensive Care Syndrome | COVID-19-associeret slagtilfældeKina
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University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico og andre samarbejdspartnereAfsluttetPostakutte følgesygdomme af COVID-19 | Tilstand efter COVID-19 | Langtids-COVID | Kronisk COVID-19 syndromItalien
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University of Missouri, Kansas CityNational Institute on Minority Health and Health Disparities (NIMHD)Aktiv, ikke rekrutterendeCovid-19 testadfærdForenede Stater
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Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, CanadaRekrutteringTræthed | Post-COVID-19 syndrom | Tilstand efter COVID-19 | Post-COVID syndrom | Lang COVID-19 | Langtids-COVID | Post-COVID tilstandCanada
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RSUP PersahabatanAfsluttetPost COVID-19 syndrom | Langt COVID-19 syndrom | Post COVID-syndrom Long CovidIndonesien
Kliniske forsøg med HCQ & AZ
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Azafaros A.G.AfsluttetNiemann-Pick sygdom, type C | GM2 GangliosidosisBrasilien
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Azafaros A.G.RekrutteringGM2 Gangliosidosis | Niemann-Pick Type C sygdomBrasilien
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Alexza Pharmaceuticals, Inc.CelerionAfsluttet
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King Hussein Cancer CenterTrukket tilbage
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University of Alabama at BirminghamAstraZenecaAfsluttetIkke-alkoholisk fedtleversygdom (NAFLD) | Ikke-alkoholisk Steatohepatitis (NASH)Forenede Stater
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Novartis PharmaceuticalsAfsluttet
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UnitedHealth GroupUniversity of Pennsylvania; ProHealth Care AssociatesAfsluttetCoronavirusinfektion | CoronavirusForenede Stater
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Azafaros A.G.RekrutteringGangliosidosis, GM1 | Gangliosidoses, GM2Frankrig, Det Forenede Kongerige, Italien, Australien, Forenede Stater, Mexico, Canada, Brasilien, Portugal, Indien, Spanien, Tyrkiet (Türkiye), Tyskland, Sverige, Argentina, Schweiz
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Azafaros A.G.RekrutteringGM2 Gangliosidosis | GM1 Gangliosidosis | Niemann-Pick Type C sygdomFrankrig, Det Forenede Kongerige, Australien, Italien, Forenede Stater, Mexico, Canada, Brasilien, Portugal, Indien, Spanien, Tyrkiet (Türkiye), Tyskland, Sverige, Argentina, Schweiz
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UNICEFPak Emirates Military Hospital Rawalpindi, PakistanAfsluttetCovid19 | ProgressionPakistan