Immune Monitoring of Prophylactic Effect of Hydroxychloroquine in Healthcare Providers Highly Exposed to COVID-19

NCT04346329 | Withdrawn Phase 3

• 1 other identifier: UNAL-COVID-CP
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This is a PILOT STUDY, a Phase III double-blind, randomized, placebo-controlled clinical study in which we assess the clinical effect of the prophylactic administration of hydroxychloroquine vs. placebo to healthcare workers working at our University Hospital (HUN). Participants in each arm (n = 43) will be administered with a unique loading dose of 800 mg of hydroxychloroquine the first day followed by 400 mg/week for 90 days. The population to be studied (uninfected healthcare personnel) will be highly exposed to SARS-CoV-2 infection. An active search should be made for individuals who become infected while participating in the study, hence, once the informed consent form is signed, the molecular test for the diagnosis of SARS-CoV-2 infection by RT-PCR will be carried out every 4 days in order to determine as closely as possible the moment the participant becomes positive. The results of the diagnostic RT-qPCR tests will be confronted with: (i) the results of immune monitoring of at least 30 immunological parameters in leukocytes and in plasma (levels of selected cytokines and chemokines analyzed by automated flow cytometry software and (ii) the daily recording of data for the presence or absence of signs and symptoms associated with SARS-Cov-2 infection. For the recording of immune monitoring 20mL blood samples will be taken at eight-time points throughout the 90 days of the stud.

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

• Adverse effects

  Number of participants with treatment-related adverse events as associated administration of hydroxychloroquine or placebo.

  six months after administration of hydroxychloroquine or placebo

Secondary Outcomes (3)

• Immune-score

  six months after administration of hydroxychloroquine or placebo

• COVID-19 prevention

  six months after administration of hydroxychloroquine or placebo

• Clinical response

  six months after administration of hydroxychloroquine or placebo

Study Arms (2)

Control

PLACEBO COMPARATOR

Controlled group with placebo medication similar to hydroxychloroquine (loading dose of 800 mg of hydroxychloroquine the first day followed by 400 mg/week for 90 days)

Drug: Placebo oral tablet

treated

EXPERIMENTAL

hydroxychloroquine with a loading dose of 800 mg of hydroxychloroquine the first day followed by 400 mg/week for 90 days

Drug: Hydroxychloroquine

Interventions

Hydroxychloroquine DRUG

Treated group

treated

Placebo oral tablet DRUG

Placebo Group

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be part of the health personnel (intensivist doctor, hospital doctors, nurses, physical therapists and support staff in the care unit) who will work at the HUN in the period of May 1st, 2020 to August 1, 2020
• Be over 18 years old, exposed to patients with COVID-19. Not having symptoms compatible with an acute respiratory infection for the last 21 days.
• Willingness to donate blood samples and for diagnosis and monitoring of SARS-COV-2 infection throughout the study period.
• Have a Smart Phone in order to facilitate permanent communication with you during the duration of the study.
• Signature of informed consent.

You may not qualify if:

• Allergy or hypersensitivity to hydroxychloroquine.
• Contraindications to the use of chloroquine (epilepsy, creatinine clearance \<30mL / min).
• Be taking (Abiraterone Acetate, Agalsidase, Conivaptan, Dabrafenib, Dacomitinib, Enzalutamide, Idelalisib), or medications that cannot be discontinued.
• Retinal disease.
• Mifepristone, Mitotane, tiripentol.
• Already established hydroxychloroquine treatment.
• Pregnancy or suspected pregnancy.
• Women in breastfeeding.
• Chronic liver disease (Child-Pugh B or C).
• Kidney disease with a Glomerular Filtration Rate of less than or equal to 30mL / min.
• Cardiac, kidney, liver, ophthalmic, neurological or autoimmune disease previously diagnosed.
• Prolongation of the QT segment in the EKG.
• Previous diagnosis of COVID-19.
• Concomitant taking of medications that prolong the QT segment

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead
• Fundación Salud de los Andes: collaborator

Study Sites (2)

Facultad de Medicina - Universidad Nacional de Colombia

Bogota, Cundinamarca, 111321, Colombia

Location

Universidad Nacional de Colombia

Bogota, Cundinamarca, 111321, Colombia

Location

MeSH Terms

Interventions

Hydroxychloroquine

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Phase III double-blind, randomized, placebo-controlled clinical study

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 15, 2020
• Study Start: March 30, 2020
• Primary Completion: June 30, 2020
• Study Completion: October 30, 2020
• Last Updated: May 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)