- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04437693
Post Exposure Prophylaxis in Healthcare Workers Exposed to COVID-19 Patients (HCQ-COVID19)
Post Exposure Prophylaxis (PEP) in Healthcare Workers Exposed to COVID-19 Patients: A Double-blind Randomized Clinical Trial
More cases of COVID-19 pandemic are being reported daily around the world. It is highly infectious and, over 7 million people have been infected and more than 400,000 people have died globally till this date. Countries around the world are struggling to avoid the spread of this pandemic.
Center for Disease Control and Prevention (CDC) confirmed that there are no approved drugs for COVID-19 treatment. Researchers around the globe, however, are researching different medications for COVID-19 patients, including the drug Hydroxychloroquine (HCQ), which is mainly used for Rheumatoid Arthritis and Malaria. Not enough data was obtained yet to know how well all of these medications are functioning. Therefore, aim to perform a randomized placebo-controlled trial to assess the impact of these medications on COVID -19 healthcare workers exposed while treating COVID 19 patients in Qatar to avoid causality and comorbidities in healthcare workers.
It is considered as a weak base. Many viruses enter the host cells via endocytosis, as a result of which they are initially taken up into an intracellular compartment that is "typically fairly acidic" whereas; Hydroxychloroquine would alter the acidity of this compartment, which can interfere with the ability of viruses to escape into the host cell and start replicating. Another hypothesis on the rationale of the Antiviral activity of HCQ, is that HCQ may also alter the ability of the virus to bind to the outside of a host cell in the first place.
An interventional, double-blind, placebo-controlled randomized trial that will include participants who will be healthcare workers at risks of exposure to COVID-19 while managing patients with confirmed infection.
Study will compare the safety, efficacy and effectiveness of Post Exposure Prophylaxis (PEP) use of HCQ in healthcare workers at risk of exposure to COVID-19 patients, in comparison to Placebo in Qatar.
Study Overview
Detailed Description
More cases of COVID-19 pandemic are being reported daily around the world. It is highly infectious and, over 7 million people have been infected and more than 400,000 people have died globally till this date. Countries around the world are struggling to avoid the spread of this pandemic. The most common symptoms of coronavirus disease are fever, fatigue, and dry cough. Most people (approximately 80 percent) recover from the disease without special care. The disease can be serious, and even fatal. Older people, and people with other medical conditions (such as asthma, diabetes, or heart disease), maybe more vulnerable to becoming severely ill. As the COVID-19 pandemic continues to affect communities throughout the world, the search for effective drugs remains a priority. Scientists across the globe are working to produce a vaccine, but unlikely to be available before 2021. Meanwhile, a growing number of countries have taken a series of systematic measures to curb coronavirus spread, including national lockdowns, meeting bans, school closings, closures of restaurants, bars, sports clubs etc
Researchers used to evaluate the invitro effectiveness of several potential COVID-19 treatments, including chloroquine (CQ) and redmeveir (RDV). The findings were found encouraging as 90 percent of the virus was inhibited by a low concentration of CQ and the results for RDV were even better-with an even lower concentration of this drug, achieving a virus inhibition of 90 percent. However, unless clinically verified, it cannot confirm these drugs for the treatment of COVID-19 patients. It is not known how well these medications function in people who are infected with COVID-19 and is still being studied. The first patient reported to be infected with COVID -19 in the U.S. was treated with RDV. The treatment started on the 7th day of hospitalization and on the 11th day after his symptoms were first identified. He started showing signs of progress on the very next day, presumably due to treatment with RDV. Further data, however, is required to confirm the effect of this treatment.
Researchers in France have also been studying the effectiveness of hydroxychloroquine (HCQ) in a single-arm regimen to treat people with COVID-19. HCQ (and, in some cases, also antibiotic azithromycin) has been used in this study to treat individuals with the COVID-19 virus in one setting. Investigators measured the amount of virus in swabs taken from these individuals and from a group of individuals who did not receive HCQ. A larger decrease in the volume of the virus from the individuals receiving HCQ occurred on a span of six days. However, the groups were not randomized. Individuals who did not receive HCQ were at various medical facilities and not necessarily like the individuals in the HCQ group. The results are intriguing. But it's important to note that scientists have expressed concerns about this study. Indeed, after the publication of these findings, a statement has been released in the journal that it did not meet the "expected standard" of research (6).
Moreover, these two drugs HCQ and RDV were designed primarily to fight other diseases and not COVID-19. Few data are available indicating that either could have some interest in the treatment of the disease, but its complete effect on COVID-19 patients is not known. One reason why researchers are interested in this drug is the HCQ's ability to modulate the inflammatory response. Inflammation is the natural reaction of the body to bacteria, viruses, or other substances that attack it. Our immune system usually attacks and actively kills infected cells or foreign bodies. But this response may often fail to function properly particularly in autoimmune disorders where the body is mistakenly attacking itself. HCQ has subtle effects on a wide variety of immune cells, and it may be that one of these effects helps stimulate the body's ability to fight off Covid-19. The inflammatory response in COVID-19 can be so strong that it causes serious damage to the lungs, that is why patients with severe infections need ventilators
Another hypothesis on the rationale of the Antiviral activity of HCQ, is that HCQ may also alter the ability of the virus to bind to the outside of a host cell in the first place.
The gold standard of a drug trial is a placebo-controlled, randomized, double-blind study. One group of participants should receive the investigational drug and another group should receive a placebo. The individuals in each arm of the study should be randomized; the demographics of both groups should be similar. Finally, the participants should not know if they are receiving the investigational drug or a placebo and the healthcare workers should not know what they are administering. Only under these conditions, It can conclusively determine the safety and efficacy of a potential treatment.
Center for Disease Control and Prevention (CDC) confirmed that there are no approved drugs for COVID-19 treatment. Researchers around the globe, however, are researching different medications for COVID-19 patients, including the drug Hydroxychloroquine, which is mainly used for the treatment of Rheumatoid Arthritis and Malaria. Not enough data was obtained yet to know how well all of these medications are functioning. Therefore, aim to perform a randomized placebo-controlled trial to assess the impact of these medications on healthcare workers who exposed for the treatment of COVID -19 patients in Qatar.
Rational to conduct a clinical trial on HCQ: It is considered as a weak base. Many viruses enter the host cells via endocytosis, as a result of which they are initially taken up into an intracellular compartment that is "typically fairly acidic" whereas; Hydroxychloroquine would alter the acidity of this compartment, which can interfere with the ability of viruses to escape into the host cell and start replicating. Another hypothesis on the rationale of the Antiviral activity of HCQ, is that HCQ may also alter the ability of the virus to bind to the outside of a host cell in the first place.
Hypothesis:
HCQ will be more safe and effective in comparison to placebo in the prevention of COVID 19 cases, in healthcare workers exposed to COVID 19 patients.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Nasser Al Ansari, FRCPath
- Phone Number: 33554409
- Email: nalansari2@hamad.qa
Study Contact Backup
- Name: Rajvir Singh, Ph.D.
- Phone Number: 55897044
- Email: rsingh@hamad.qa
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years or older, all healthcare workers in direct contact with COVID-19 patients (ex: physicians, nurses, pharmacists, etc.), the ability to swallow Oral medications, without any GI abnormalities that may affect absorption. Who agree to participate in the trial.
Exclusion Criteria:
- Allergy to HCQ.
- Pregnancy or breastfeeding.
- Known history of Retinal disease not related to Macular degeneration, or preexisting eye retinopathy.
- Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia.
- Having a prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
- Having dermatitis, psoriasis, or porphyria.
- History of lung disease or Pneumonia not related to COVID-19.
- Taking CYP450 enzyme-inducing medications within 4 weeks of the start of taking HCQ (Ex: Phenytoin, Carbamazepine, Phenobarbital, Primidone or Oxcarbazepine.
- Currently taking QT-prolonging medications, which may include Antiarrhythmics, Quinolones, Macrolides, select Antipsychotics and Antidepressants.
- Team members planning to have major abdominal, thoracic, spine or CNS surgery during the protocol period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hydroxychloroquine
400mg twice a day on day 1 followed by 400 mg weekly for 7 weeks.
|
The treatment group that will receive Hydroxychloroquine (HCQ) 400mg twice a day on day 1 followed by 400 mg weekly for 7 weeks
Other Names:
|
Placebo Comparator: Placebo
2 tablets (Placebo White tablets) twice daily on day 1 followed by 2 tablets weekly for 7 weeks
|
The treatment group that will receive Hydroxychloroquine (HCQ) 400mg twice a day on day 1 followed by 400 mg weekly for 7 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevention of SARS-CoV-2 infection
Time Frame: 7 Months
|
Prevention of SARS-CoV-2 infection as determined by negative RT-PCR of the participants in the treatment group through swabbing that will be conducted on a weekly basis (Swabbing will be conducted at baseline and weekly through the end of the treatment period
|
7 Months
|
Presence of any adverse effects related to HCQ
Time Frame: 7 months
|
To find out the adverse effects related to HCQ such as : skin rashes, especially those made worse by sunlight, feeling sick (nausea) or indigestion, diarrhea, headaches, bleaching of the hair or mild hair loss, tinnitus (ringing in the ears) visual problem
|
7 months
|
Incidence of COVID-19 related symptoms
Time Frame: 7 weeks
|
Incidence of COVID-19 related symptoms, that may include: Temperature over 37.8 degrees Celsius, Shortness of Breath, Cough.
|
7 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nasser Al Ansari, FRCPath, Hamad Medical Corporation (HMC)
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Hydroxychloroquine
Other Study ID Numbers
- MRC-02-20-442
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Study Data/Documents
-
Clinical Study Report
Information comments: https://www.worldometers.info/coronavirus/
-
Clinical Study Report
Information comments: https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on COVID 19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
Clinical Trials on Hydroxychloroquine
-
Cambridge University Hospitals NHS Foundation TrustUnknown
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)WithdrawnMyelodysplastic Syndromes | Progressive DiseaseUnited States
-
Health Institutes of TurkeyCompleted
-
University of MichiganCures Within ReachRecruitingRetinitis PigmentosaUnited States
-
University Hospital, MontpellierTerminatedCoronavirus Infection | Pneumonia, ViralFrance
-
Assistance Publique - Hôpitaux de ParisCompletedSARS-CoV-2 InfectionFrance
-
Peng Wang, MD PhDCompleted
-
Ravi Amaravadi, MDTerminatedCOVID-19United States
-
Hospital do CoracaoHospital Israelita Albert Einstein; Hospital Sirio-Libanes; Brazilian Research... and other collaboratorsCompletedCoronavirus InfectionsBrazil
-
Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)CompletedLymphangioleiomyomatosisUnited States