COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001697-30/ES

CLINICAL TRIAL UNIT - RUTH GARCÍA

ruth.garcia.rey@navarra.es

2020-05-07

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Prevention

1. Sanitary with high exposure to COVID-19 with training of doctor or DUE belonging to the health network of Navarra 2. No previous diagnosis of COVID-19 3. Not present symptoms compatible with COVID-19, neither present nor past 4. Negative Ig M or Ig G negative immunochromatography test result for both 5. You agree not to self-medicate with chloroquine, hydroxychloroquine, or other potential antivirals. 6. That they give their written informed consent to participate in the trial 7. Not being pregnant. To do this, if you suspect that you might be, you should have previously had a pregnancy test. 1. Sanitario con alta exposición a COVID-19 con formación de médico o DUE perteneciente a la red sanitaria de Navarra 2. No diagnóstico previo de COVID-19 3. No presentar síntomas compatibles con COVID-19 ni presentes ni pasados 4. Resultado de test rápido de inmunocromatografía de Ig M o Ig G negativo para ambos 5. Consiente no automedicarse con cloroquina , hidroxicloroquina ni otros potenciales antivirales. 6. Que otorguen su consentimiento informado por escrito para participar en el ensayo. 7. No estar embarazada, para ello si sospecha que pudiera estarlo deberá realizarse previamente un test de embarazo.

1. Hypersensitivity to chloroquine or derivatives. 2. Contraindication to taking hydroxychloroquine (for epilepsy, severe kidney failure (clearance <10 ml / min), severe liver failure). 3. Known retinopathy. 4. Impossibility to continue in the trial during the 6 weeks of treatment. 5. Taking concomitant contraindicated medication: aremeter / lumefantrine and mefloquine as antimalarials, natalizumab, pimecrolimus and tacroliums, moxifloxacin, agasidase alfa and beta, dapsone, tratuzumab, drugs that lengthen QT such as digoxin, amiodarone and some beta blockers. 6. Pregnancy or pregnancy wish in the next 6 weeks. 7. Glucose 6-Phosphate Dehydrogenase deficiency that generates hereditary hemolytic anemia. 1. Hipersensibilidad a la cloroquina o derivados. 2. Contraindicación de la toma de hidroxicloroquina (por epilepsia, insuficiencia renal grave (aclaramiento <10 ml/min) , insuficiencia hepática grave). 3. Retinopatía conocida. 4. Imposibilidad de continuar en el ensayo durante las 6 semanas de tratamiento. 5. Toma de medicación contraindicada concomitante : aremeter/lumefantrina y mefloquina como antimaláricos, natalizumab, pimecrolimus y tacroliums, moxifloxacino, agasidasa alfa y beta, dapsona, tratuzumab, fármacos que alargan QT como digoxina, amiodarona y algunos beta bloqueantes. 6. Embarazo o deseo de embarazo en las próximas 6 semanas. 7. Déficit de Glucosa 6-Fosfato-Deshidrogenasa que genera anemia hemolítica hereditaria.

2

NAVARRABIOMED - FUNDACIÓN MIGUEL SERVET

18

None

Spain

Health workers

N/A

200

 Appearance of Ig M in rapid test YES / NO  Appearance of Ig G in rapid test YES / NO  Appearance of symptoms compatible with COVID-19: fever, cough, odynophagia, vomiting or diarrhea, headache, anosmia or hyposmia, ageusia or dysgeusia without any other alternative diagnosis  Positive PCR with compatible symptoms carried out in occupational risks (YES / NO)  Aparición de Ig M en test rápido SI/NO  Aparición de Ig G en test rápido SI/NO  Aparición de síntomas compatibles con COVID-19: fiebre, tos, odinofagia, vómitos o diarrea, cefalea , anosmia o hiposmia, ageusia o disgeusia sin otro diagnóstico alternativo  PCR positivo con síntomas compatibles realizado en riesgos laborales (SI/NO)

Declared number of arm (2.0) differs from found arms (1.0)

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]