- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04363866
Assessing Hydroxychloroquine in Patients With SARS-CoV-2 (COVID-19)
A Randomized-Control Pilot Study to Assess Hydroxychloroquine in Patients Infected With SARS-CoV-2 (COVID-19)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A total of 40 participants are planned for enrollment. Those enrolled into this study will be randomized 1:1 to receive either hydroxychloroquine or placebo control.
Participants will receive their study intervention for 5 days, after which they will be considered off protocol- directed therapy and receive medical management of their disease according to institutional standards. Participants may be followed for up to 180 days from initiating protocol therapy for clinical outcome, after which they will discontinue study participation.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ability to understand and the willingness to sign a written informed consent document.
- Individuals aged ≥ 18 years of all races and ethnic groups.
- Must have documented positive test result for SARS-CoV-2 (COVID19), or high clinical suspicion for SARS-CoV-2 based on presence of typical clinical findings (e.g., fever, respiratory symptoms, pulmonary abnormalities on chest X-ray or CT scan), lack of alternative diagnosis, and history of exposure to a known case of SARS-CoV- 2 infection within the past 14 days
- Not receiving institutional therapy for treatment of SARS-CoV-2, including (but not limited to) remdesivir, chloroquine, hydroxychloroquine, or any other investigational agent(s).
Must meet at least one of the following clinical stratifications:
- Have at least 1 minor criterion per ATS criteria (refer to Appendix A), or
- Have fever, respiratory symptoms, with pneumonia visible on chest imaging (e.g., X-ray or computed tomography [CT]), or
- High risk for poor outcome, as defined by any one of the following:
i. Age ≥ 60 years old ii. Underlying medical comorbidities, defined as:
- Serious cardiovascular disease
- Poorly controlled diabetes (i.e., A1c levels >7%)
- Chronic kidney disease requiring dialysis
- Significant liver disease (Pugh-Child B or C)
- Severe obesity (body mass index [BMI] ≥ 40)
- Chronic respiratory disease (e.g., COPD)
- Hypertension, defined as blood pressure ≥ 140 / 90 mmHg iii. Solid organ or stem cell transplant recipient iv. Diagnosis of solid or hematologic malignancy being treated with systemic chemotherapy v. Receipt of biologic agent or prednisone > 0.5 mg/kg/day (or equivalent)
- Patient must be within 5 days of symptom onset, as determined by clinical team.
- Participants with preexisting auditory damage are allowed.
- Participants with a history of epilepsy are allowed.
- Female participants of childbearing potential (FOCBP) must have a negative serum or urine pregnancy test (per institutional standards) prior to the start of study drug.
- FOCBP must agree to use highly-effective method(s) of contraception (Appendix B) during the study and for 1 months after the last dose of study drug. FOCBP are those who have not been surgically sterilized or have not been free from menses for >1 year without an alternative medical cause.
- Male participants must agree to use an adequate method of contraception (Appendix B) starting with the first dose of study therapy through at least 1 months after the last dose of study drug.
- Participant must agree to not breastfeed during the study or for 30 days after the last dose of study treatment.
Exclusion Criteria:
- The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Psychiatric illness/social situations, or any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results, or substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
- Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or participants with congenital long QT syndrome
- Patients with Myesthenia Gravis or other neuromuscular disorders
Patients with history of psoriasis.
a. May be waived at the discretion of the PI
Patients with history of porphyria
a. May be waived at the discretion of the PI
- Concomitant use of other antiviral agents for the study's duration, but may be waived at discretion of the Principal Investigator
- Hypersensitivity to the study agent, or any of its excipients.
- Females who are pregnant or lactating.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hydroxychloroquine
400 mg bid (PO) Day 1, followed by 200 mg bid (PO) Day 2 through Day 5
|
Hydroxychloroquine is more polar, less lipophilic, and has more difficulty diffusing across cell membranes than the parent compound, chloroquine.
These characteristics result in hydroxychloroquine having a longer half-life, comparatively lower toxicity to chloroquine, as well as fewer concerns pertaining to drug-drug interactions
|
Placebo Comparator: Placebo
Placebo pill bid (PO) Day 1 through Day 5 of the treatment period
|
A placebo is a pill that looks like the study drug but has no real medicine in it.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Status at Day 5 Assessed by a 6-Point Ordinal Scale
Time Frame: Day 5
|
A 6-point ordinal scale ranging from "Death" to "Not hospitalized with full resumption of normal activities" is used to evaluate differences in the clinical status between participants that receive placebo vs hydroxychloroquine
|
Day 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Detectable SARS-CoV-2 Virus from Day 0 to Day 28 and at Day 5
Time Frame: Day 0 to Day 28 and at Day 5
|
Assess differences in SARS-CoV-2 viral shedding between participants that receive placebo vs hydroxychloroquine
|
Day 0 to Day 28 and at Day 5
|
Toxicity of Study Drug Assessed by Incidence of Adverse Events
Time Frame: Day 0 to Day 28
|
Assess by incidence of Grade 3, Grade 4, and Serious Adverse Events (AEs)
|
Day 0 to Day 28
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Initial Hospitalization
Time Frame: Day 0 to Day 28
|
Assess length of hospitalization
|
Day 0 to Day 28
|
Mortality During Follow-Up
Time Frame: Day 0 to Day 28
|
Assess number of deaths during study follow-up
|
Day 0 to Day 28
|
Mortality During Initial Hospitalization
Time Frame: Day 0 to Day 28
|
Assess number of deaths in the hospital during initial hospitalization
|
Day 0 to Day 28
|
Incidence of New Hospital Resource Utilization
Time Frame: Day 0 to Day 28
|
Assessing utilization of hospital resources
|
Day 0 to Day 28
|
Duration of Hospital Resource Utilization
Time Frame: Day 0 to Day 28
|
Assessing duration of hospital resource utilization
|
Day 0 to Day 28
|
Changes in Cytokine Profile
Time Frame: Day 0 to Day 28
|
Provide preliminary characterization of differences in inflammatory response between participants that receive placebo vs hydroxychloroquine
|
Day 0 to Day 28
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marcel Curlin, MD, Oregon Health and Science University
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
- STUDY00021303
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
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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
-
Peng Wang, MD PhDCompleted
-
University of MichiganCures Within ReachRecruitingRetinitis PigmentosaUnited States
-
University Hospital, MontpellierTerminatedCoronavirus Infection | Pneumonia, ViralFrance
-
Assistance Publique - Hôpitaux de ParisCompletedSARS-CoV-2 InfectionFrance
-
Hospital do CoracaoHospital Israelita Albert Einstein; Hospital Sirio-Libanes; Brazilian Research... and other collaboratorsCompletedCoronavirus InfectionsBrazil
-
Ravi Amaravadi, MDTerminatedCOVID-19United States
-
Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)CompletedLymphangioleiomyomatosisUnited States