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| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
| Laboratorios Rubió | UNKNOWN |
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | OTHER |
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The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-exposure prophylaxis of SARS-CoV-2 | Experimental | Participants will receive hydroxychloroquine 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months |
|
| Control group with placebo | Placebo Comparator | Participants will receive placebo 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | Hydroxychloroquine with the following dosage:
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed cases of a COVID-19 | Confirmed cases of a COVID-19 (defined by a positive PCR for SARS-CoV-2 or symptoms compatible with COVID-19 with seroconversion) in the PrEP group compared to the placebo group at any time during the 6 months of the follow-up in healthcare workers with negative PCR for SARS-CoV-2 on day 0 and negative serology for SARS-CoV-2 on day 0. | Up to 6 months after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 seroconversion | SARS-CoV-2 seroconversion in the PrEP group compared to placebo in during 6 months of follow-up in healthcare workers with negative serology at day 0. | Up to 6 months after start of treatment |
| Occurrence of any adverse event related with hydroxychloroquine treatment |
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Inclusion Criteria:
Exclusion Criteria:
Age <18 years
Pregnancy or breastfeeding
Ongoing antiviral or antiretroviral treatment or HIV positive
Ongoing anti-inflammatory treatment (corticosteroids)
Ongoing or previous (1 month) chloroquine or hydroxychloroquine treatment
Confirmed case of SARS-CoV-2 infection (positive PCR) at day 0
Positive serology for SARS-CoV-1 infection at day 0
Impossibility of signing the informed consent form
Rejection of participation
Working less than 3 days a week in the Hospital Clinic of Barcelona.
Any contraindication for hydroxychloroquine treatment:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Muñoz Gutiérrez, MD, PhD | Barcelona Institute for Global Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISGlobal | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34781981 | Derived | Grau-Pujol B, Camprubi-Ferrer D, Marti-Soler H, Fernandez-Pardos M, Carreras-Abad C, Andres MV, Ferrer E, Muelas-Fernandez M, Jullien S, Barilaro G, Ajanovic S, Vera I, Moreno L, Gonzalez-Redondo E, Cortes-Serra N, Roldan M, Arcos AA, Mur I, Domingo P, Garcia F, Guinovart C, Munoz J. Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial. Trials. 2021 Nov 15;22(1):808. doi: 10.1186/s13063-021-05758-9. | |
| 32727613 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Hospital Plató |
| OTHER |
| Hospital de Granollers | OTHER |
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| Placebos | Drug | Placebo with the following dosage:
|
|
Incidence of clinical and/or laboratory adverse events will be compared in the PrEP group and in the placebo arm. |
| Up to 6 months after start of treatment |
| Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers | Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers will be estimated by the number of healthcare workers diagnosed with COVID-19 in the placebo group, among the total of healthcare workers included in the non-PrEP group during the study period. | Up to 6 months after start of treatment |
| Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19 | Up to 6 months after start of treatment |
| COVID-19 Biobank | A repository (biobank) of serum samples obtained from healthcare workers confirmed COVID-19 cases for future research on blood markers to predict SARS-CoV-2 infection. | Up to 6 months after start of treatment |
| Derived |
| Grau-Pujol B, Camprubi D, Marti-Soler H, Fernandez-Pardos M, Guinovart C, Munoz J. Pre-exposure prophylaxis with hydroxychloroquine for high-risk healthcare workers during the COVID-19 pandemic: A structured summary of a study protocol for a multicentre, double-blind randomized controlled trial. Trials. 2020 Jul 29;21(1):688. doi: 10.1186/s13063-020-04621-7. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |