Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic

COVID-19 Clinical Trial

— PrEP_COVID  

Official title:

Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic: A Multicentre, Double-Blinded Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04331834
• Other study ID #: PrEP_COVID
• Status: Completed
• Phase: Phase 3
• Start date: April 3, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2023
• Source: Barcelona Institute for Global Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: December 31, 2020
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Negative PCR and negative serology on day 0

• Healthcare worker at any of the trial sites

• Female participants: negative for pregnancy test

• Willing to participate in the study

• Able to sign the informed consent form

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:

• Hydroxychloroquine hypersensitivity or 4-aminoquinoline hypersensitivity

• Retinopathy, visual field or visual acuity disturbances

• QT prolongation, bradycardia (<50bpm), ventricular tachycardia, other arrhythmias, as determined on day 0 ECG or medical history

• Potassium < 3 mEq/L or AST or ALT > 5 upper normal limit, as determined on day 0 blood test

• Previous myocardial infarction

• Myasthenia gravis

• Porphyria

• Glomerular clearance < 10ml/min

• Previous history of severe hypoglycaemia

• Ongoing treatment with antimalarials, antiarrhythmic, tricyclic antidepressants, selective serotonin reuptake inhibitors, natalizumab, quinolones, macrolides, agalsidase alfa and beta.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Hydroxychloroquine
Hydroxychloroquine with the following dosage: day 0: 400 mg (2 tablets) day 1: 400 mg (2 tablets) day 2: 400 mg (2 tablets) day 3: 400 mg (2 tablets) weekly: 400 mg (2 tablets) for a period of six months
• Placebos
Placebo with the following dosage: day 0: 400 mg (2 tablets) day 1: 400 mg (2 tablets) day 2: 400 mg (2 tablets) day 3: 400 mg (2 tablets) weekly: 400 mg (2 tablets) for a period of six months

Locations

Country	Name	City	State
Spain	ISGlobal	Barcelona

Sponsors (6)

Lead Sponsor	Collaborator
Barcelona Institute for Global Health	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona, Hospital de Granollers, Hospital Plató, Laboratorios Rubió

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Occurrence of any adverse event related with hydroxychloroquine treatment	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
Secondary	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
Secondary	Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19		Up to 6 months after start of treatment
Secondary	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