PRE-EXPOSURE PROPHYLAXIS WITH HYDROXYCHLOROQUINE IN SANITARIES HIGHLY EXPOSED TO COVID-19. (COVIDNA)

PRE-EXPOSURE PROPHYLAXIS WITH HYDROXYCHLOROQUINE IN SANITARIES HIGHLY EXPOSED TO COVID-19. (COVIDNA) - COVIDNA

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001697-30-ES

Enrollment

200

Registered

2020-05-07

Start date

2020-04-23

Completion date

Unknown

Last updated

2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PRE-EXPOSURE PROPHYLAXIS WITH HYDROXYCHLOROQUINE IN SANITARIES HIGHLY EXPOSED TO COVID-19

Interventions

Trade Name: HYDROXYCHLOROQUINE Pharmaceutical Form: Tablet INN or Proposed INN: Hydroxychloroquine CAS Number: 118-42-3 Concentration unit: Bq/mg becquerel(s)/milligram Concentration type: equal Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: ? Assess whether there are differences between the two groups in the severity of the disease if IgM antibodies appear. Gravity will be measured as: o Duration of symptoms o Development of viral pneumonia o Specify hydroxychloroquine dose increase o Increased antiviral medication (kaletra ... etc) during the study. o Need for hospital admission o ICU admission ? Assess the clinical safety of hydroxychloroquine in subjects without comorbidities and its QTc lengthening effect. ? Assess in both groups whether the appearance of Ig G antibodies protects against the new appearance of disease understood as the appearance of new IgM antibodies in the period studied. ? Estimation of the percentage of these toilets that have been able to pass the oligosymptomatic disease (Ig M or Ig G positive) in the initial sampling of healthy candidates.;Main Objective: To assess the efficacy and safety of 155 mg of hydroxychloroquine base as prophylaxis in health professionals subjected to repeated exposures to the COVID-19 virus, to reduce the contagion measured as development of Ig M antibodies. Professionals must be negative for the disease at the beginning of the randomized study.;Primary end point(s): ? 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);Timepoint(s) of evaluation of this end point: 6 WEEKS	—

Measure

Time frame

Secondary Objective: ? Assess whether there are differences between the two groups in the severity of the disease if IgM antibodies appear. Gravity will be measured as: o Duration of symptoms o Development of viral pneumonia o Specify hydroxychloroquine dose increase o Increased antiviral medication (kaletra ... etc) during the study. o Need for hospital admission o ICU admission ? Assess the clinical safety of hydroxychloroquine in subjects without comorbidities and its QTc lengthening effect. ? Assess in both groups whether the appearance of Ig G antibodies protects against the new appearance of disease understood as the appearance of new IgM antibodies in the period studied. ? Estimation of the percentage of these toilets that have been able to pass the oligosymptomatic disease (Ig M or Ig G positive) in the initial sampling of healthy candidates.;Main Objective: To assess the efficacy and safety of 155 mg of hydroxychloroquine base as prophylaxis in health professionals subjected to repeated exposures to the COVID-19 virus, to reduce the contagion measured as development of Ig M antibodies. Professionals must be negative for the disease at the beginning of the randomized study.;Primary end point(s): ? 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);Timepoint(s) of evaluation of this end point: 6 WEEKS

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Secondary

Measure	Time frame
Secondary end point(s): ? Pneumonia compatible with COVID-19 YES / NO ? Days duration symptoms compatible with COVID19 ? Increased hydroxychloroquine YES / NO ? Increased dose of hydroxychloroquine (0 = no change from group assigned 1 = 0 to 200mg Hcl / day; 2 = 200 to 400 mg Hcl / day; 3 = 0 to 400mg Hcl / day) ? Treatment with lopinavir / ritonavir (Kaletra ?) YES / NO ? Corticosteroid treatment YES / NO ? Income for pneumonia YES / NO ? Number of days of admission ? ICU admission YES / NO ? Number of days of ICU admission ? Elongation of the QTc in the second ECG (> 460 msg) (third week of the study) ? Number of weekly hours worked ? Reinfection measured as positive Ig M after presenting Ig G YES / NO ? Percentage Ig M or Ig G positive in the initial sample of candidates without self-perceived symptoms of COVID-19 excluded to participate in the study for this reason.;Timepoint(s) of evaluation of this end point: 6 WEEKS	—

Measure

Time frame

Secondary end point(s): ? Pneumonia compatible with COVID-19 YES / NO ? Days duration symptoms compatible with COVID19 ? Increased hydroxychloroquine YES / NO ? Increased dose of hydroxychloroquine (0 = no change from group assigned 1 = 0 to 200mg Hcl / day; 2 = 200 to 400 mg Hcl / day; 3 = 0 to 400mg Hcl / day) ? Treatment with lopinavir / ritonavir (Kaletra ?) YES / NO ? Corticosteroid treatment YES / NO ? Income for pneumonia YES / NO ? Number of days of admission ? ICU admission YES / NO ? Number of days of ICU admission ? Elongation of the QTc in the second ECG (> 460 msg) (third week of the study) ? Number of weekly hours worked ? Reinfection measured as positive Ig M after presenting Ig G YES / NO ? Percentage Ig M or Ig G positive in the initial sample of candidates without self-perceived symptoms of COVID-19 excluded to participate in the study for this reason.;Timepoint(s) of evaluation of this end point: 6 WEEKS

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Countries

Spain

Contacts

Public ContactRUTH GARCÍA

CLINICAL TRIAL UNIT

ruth.garcia.rey@navarra.es0034848422163

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026