- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04346329
Immune Monitoring of Prophylactic Effect of Hydroxychloroquine in Healthcare Providers Highly Exposed to COVID-19 (Chloroquine UN)
April 29, 2021 updated by: Carlos Alberto Parra Lopez, Universidad Nacional de Colombia
Immune Monitoring of Prophylactic Effect of Hydroxychloroquine in Healthcare Providers Highly Exposed to SARS-Cov-2
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
The personnel responsible for caring of patients infected by the SARS-CoV-2 virus: doctors, nurses and paramedics working at Intensive Care Units (ICUs)), are at high risk of SARS-CoV-2 infection.
Epidemiological figures suggest a high morbidity and mortality of doctors responsible for the care of infected individuals, a factor that darkens further the panorama of the current pandemic.
The present proposal has two specific aims: (i) to evaluate whether hydroxychloroquine, used prophylactically at low dose (400mg/week for three months), protect against SARS-CoV-2 infection; and (ii) to examine whether exhaustion and senescence of immune system cells are associated to higher risk of SARS-CoV-2 infection.
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.
Taking into account that around 80% do not express symptoms or that these are mild, an active search should be made for individuals who become infected while participating in the study.
For this, 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 become positive.
The results of the diagnostic RT-PCR tests will be confronted with: (i) the results of immune monitoring of at least 30 immunological parameters in leukocytes (number and phenotype of: PMN cells, monocytes, T- and B-lymphocytes and NK-cells) and in plasma (levels of IL-2, IL-6, IL-7, IL-10, GM-CSF, TNF-a, IP-10, MCP-1, MIP-IA, IL-1, CRP, Type IFN-alpha and IFN-betta), analyzed by automated flow cytometry software such as tSNE, SPADE, FlowSOM, among others (see attached file); and (ii) the daily recording of data on 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 (day 0) and at 8, 15, 21, 30, 45, 60 and 90 days in order to monitor the baseline of immune functionality throughout the 90 days of the study.
In summary, this proposal seeks to identify immunological markers of the immune system important for defense against SARS-CoV-2, that may be useful as prognostic markers for clinical response and treatment of patients with COVID-19, and also, to evaluates whether Hydroxychloroquine, used prophylactically, has a role in protecting against SARS-CoV-2 infection in a group of healthcare workers.
If hydroxychloroquine, as we all hope, turns out to be an agent that prevent SARS-Cov-2 infection, a significant group of healthcare workers at HUN at risk of becoming ill during the epidemiological peak (expected May 1st), will be protected thanks to their participation in this study.
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cundinamarca
-
Bogota, Cundinamarca, Colombia, 111321
- Universidad Nacional de Colombia
-
Bogota, Cundinamarca, Colombia, 111321
- Facultad de Medicina - Universidad Nacional de Colombia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Control
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)
|
Placebo Group
|
EXPERIMENTAL: treated
hydroxychloroquine with a loading dose of 800 mg of hydroxychloroquine the first day followed by 400 mg/week for 90 days
|
Treated group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse effects
Time Frame: six months after administration of hydroxychloroquine or placebo
|
Number of participants with treatment-related adverse events as associated administration of hydroxychloroquine or placebo.
|
six months after administration of hydroxychloroquine or placebo
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune-score
Time Frame: six months after administration of hydroxychloroquine or placebo
|
Percentage of expression of immune senescence in cells of the immune system of individuals highly exposed to COVID-19 who receive hydroxychloroquine prophylactically vs. placebo.
|
six months after administration of hydroxychloroquine or placebo
|
COVID-19 prevention
Time Frame: six months after administration of hydroxychloroquine or placebo
|
Correlate the immunological profile of highly exposed individuals with SARS-CoV-2 with the clinic of COVID-19.
|
six months after administration of hydroxychloroquine or placebo
|
Clinical response
Time Frame: six months after administration of hydroxychloroquine or placebo
|
Determine the clinical outcome in observation timeframe of highly exposed personnel when receiving hydroxychloroquine vs. placebo prophylactically.
|
six months after administration of hydroxychloroquine or placebo
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 30, 2020
Primary Completion (ACTUAL)
June 30, 2020
Study Completion (ACTUAL)
October 30, 2020
Study Registration Dates
First Submitted
April 10, 2020
First Submitted That Met QC Criteria
April 13, 2020
First Posted (ACTUAL)
April 15, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 5, 2021
Last Update Submitted That Met QC Criteria
April 29, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNAL-COVID-CP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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