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

Phase 1

• Conditions: PRE-EXPOSURE PROPHYLAXIS WITH HYDROXYCHLOROQUINE IN SANITARIES HIGHLY EXPOSED TO COVID-19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001697-30-ES
• Lead Sponsor: AVARRABIOMED - FUNDACIÓN MIGUEL SERVET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-07
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified