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https://clinicaltrials.gov/ct2/show/NCT04308668
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6park.comHomeSearch ResultsStudy Record Detail 6park.com Save this study 6park.comPost-exposure Prophylaxis for SARS-Coronavirus-2 6park.comThe safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. 6park.com 6park.comClinicalTrials.gov Identifier: NCT04308668
Recruitment Status : Recruiting
First Posted : March 16, 2020 6park.comLast Update Posted : March 19, 2020 6park.comSee Contacts and Locations 6park.com 6park.comSponsor: 6park.comUniversity of Minnesota 6park.comInformation provided by (Responsible Party): 6park.comUniversity of Minnesota 6park.comStudy DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record 6park.comStudy Description 6park.comGo to6park.comBrief Summary: 6park.comStudy Objective: To test if post-exposure prophylaxis with hydroxychloroquine can prevent progression development of symptomatic COVID19 disease after known exposure to the SARS-CoV2 virus. 6park.comCondition or disease Intervention/treatment Phase Corona Virus InfectionAcute Respiratory Distress SyndromeSARS-CoV InfectionDrug: HydroxychloroquineOther: PlaceboPhase 2Phase 3
6park.comDetailed Description: 6park.comSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging viral infection causing COVID19. The current strategy uses a public health model of identifying infected cases, isolation, and quarantine to stop transmission. Once exposed, observation is standard-of-care.
No effective therapy currently exists for treatment. The lack of effective therapy diminishes persons presenting post-exposure for self-quarantine. Having an effective post-exposure prophylaxis, even if only partially effective, may additionally create synergy for the public health strategy of case identification and isolation - if a safe prophylaxis is available. People who develop COVID-19 disease generally develop signs and symptoms, including mild respiratory symptoms and fever, after an average of 5-6 days after exposure (i.e. mean incubation period). The range of the incubation period is between 1 to 14 days.
Most people infected with the COVID-19 virus have mild disease and recover. Approximately 80% of laboratory-confirmed patients have had mild to moderate disease, which includes non-pneumonia and pneumonia cases, 14% have severe disease, and 6% are critically ill with respiratory failure, shock, and/or multiple organ dysfunction.
Chloroquine or Hydroxychloroquine may have antiviral effects against SARS-COV2 which may prevent COVID19 disease or early preemptive therapy may ameliorate disease severity. This trial will use a modification of standard malaria dosing of hydroxychloroquine to provide post-exposure prophylaxis / preemptive therapy.
The trial is open to enrollment of healthcare workers or household contacts from across the United States. For information on how to participate in the research trial, please email covid19@umn.edu for instructions. 6park.com
Study Design 6park.comGo to6park.com
Study Type :Interventional (Clinical Trial)Estimated Enrollment :1500 participantsAllocation:RandomizedIntervention Model:Parallel AssignmentMasking:Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose:TreatmentOfficial Title:Post-exposure Prophylaxis for SARS-Coronavirus-2: A Pragmatic Randomized Clinical TrialEstimated Study Start Date :March 17, 2020Estimated Primary Completion Date :May 2021Estimated Study Completion Date :May 20216park.com
Resource links provided by the National Library of Medicine
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MedlinePlus related topics: Coronavirus Infections 6park.comDrug Information available for: Hydroxychloroquine 6park.comGenetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress SyndromeSevere Acute Respiratory Syndrome 6park.comU.S. FDA Resources 6park.comArms and Interventions 6park.comGo to6park.com Placebo Comparator: Placebo
Arm Intervention/treatment Experimental: Treatment
Participants in this arm will receive the study drug.
Drug: Hydroxychloroquine
200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 6 consecutive days 6park.com
Participants in this arm will receive a placebo treatment.
Other: Placebo
4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 6 consecutive days 6park.com 6park.comOutcome Measures 6park.comGo to6park.comPrimary Outcome Measures :Incidence of COVID19 Disease [ Time Frame: 14 days ]
Number of participants at 14 days post enrollment with active COVID19 disease. 6park.comOrdinal Scale of COVID19 Disease Severity [ Time Frame: 14 days ]
Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm. 6park.com 6park.comSecondary Outcome Measures :Incidence of Hospitalization [ Time Frame: 14 days ]
Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease. 6park.comIncidence of Death [ Time Frame: 90 days ]
Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease. 6park.comIncidence of Confirmed SARS-CoV-2 Detection [ Time Frame: 14 days ]
Outcome reported as the number of participants in each arm who have confirmed SARS-CoV-2 infection. 6park.comIncidence of Symptoms Compatible with COVID19 (possible disease) [ Time Frame: 90 days ]
Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID19 infection. 6park.comIncidence of All-Cause Study Medicine Discontinuation or Withdrawal [ Time Frame: 14 days ]
Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason. 6park.com 6park.comEligibility Criteria 6park.comGo to6park.com 6park.com
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. 6park.com
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)Sexes Eligible for Study: AllAccepts Healthy Volunteers: Yes
Criteria 6park.comInclusion Criteria:
Exposure to a COVID19 case within 3 days as either a healthcare worker or household contactProvision of informed consentExclusion Criteria:
6park.comContacts and Locations 6park.comGo to
Symptomatic COVID19 diseaseCurrent Symptoms of: Fever, Cough, or Shortness of BreathContraindication or allergy to hydroxychloroquineRetinal eye diseaseKnown glucose-6 phosphate dehydrogenase (G-6-PD) deficiencyKnown chronic kidney disease, stage 4 or 5 or receiving dialysisWeight < 40 kgCurrent use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor; amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, propafenone, Rythmal) 6park.com6park.comInformation from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308668 6park.com
Contacts 6park.comContact: David Boulware, MD, MPH612-625-4652covid19@umn.edu 6park.com
Locations 6park.comUnited States, MinnesotaUniversity of MinnesotaRecruitingMinneapolis, Minnesota, United States, 55455Contact: David Boulware, MD, MPH covid19@umn.edu 6park.comSponsors and Collaborators 6park.comUniversity of Minnesota 6park.comInvestigators 6park.comPrincipal Investigator:David Boulware, MD, MPHUniversity of Minnesota 6park.comMore Information 6park.comGo to6park.comResponsible Party:University of MinnesotaClinicalTrials.gov Identifier:NCT04308668 History of ChangesOther Study ID Numbers:STUDY00009267
First Posted:March 16, 2020 Key Record DatesLast Update Posted:March 19, 2020Last Verified:March 2020Individual Participant Data (IPD) Sharing Statement:Plan to Share IPD:No
Studies a U.S. FDA-regulated Drug Product:YesStudies a U.S. FDA-regulated Device Product:No
Keywords provided by University of Minnesota: 6park.comCOVID-19
Corona Virus
SARS-COV-2
6park.comAdditional relevant MeSH terms: 6park.comInfection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Virus Diseases
Lung Injury
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents 6park.com
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