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A Pilot Study to Assess Hydroxychloroquine in Patients With SARS-CoV-2 (COVID-19)

The 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.
 
ClinicalTrials.gov Identifier: NCT04363866
Recruitment Status : Not yet recruiting
First Posted : April 27, 2020
Last Update Posted : April 27, 2020
Sponsor:
Collaborator:
OHSU Knight Cancer Institute
Information provided by (Responsible Party):
Marcel Curlin, Oregon Health and Science University

Brief Summary:
This is a prospective, randomized, participant-blinded, placebo-controlled, pilot study to assess the preliminary efficacy and safety of hydroxychloroquine for the treatment of patients with lower respiratory tract SARS-CoV-2 infection.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Drug: Hydroxychloroquine Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: While participants will be blinded to the study intervention, study staff will be aware of treatment assignment.
Primary Purpose: Treatment
Official Title: A Randomized-Control Pilot Study to Assess Hydroxychloroquine in Patients Infected With SARS-CoV-2 (COVID-19)
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydroxychloroquine
400 mg bid (PO) Day 1, followed by 200 mg bid (PO) Day 2 through Day 5
Drug: Hydroxychloroquine
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
Drug: Placebo
A placebo is a pill that looks like the study drug but has no real medicine in it.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)


Other Outcome Measures:
  1. Duration of Initial Hospitalization [ Time Frame: Day 0 to Day 28 ]
    Assess length of hospitalization

  2. Mortality During Follow-Up [ Time Frame: Day 0 to Day 28 ]
    Assess number of deaths during study follow-up

  3. Mortality During Initial Hospitalization [ Time Frame: Day 0 to Day 28 ]
    Assess number of deaths in the hospital during initial hospitalization

  4. Incidence of New Hospital Resource Utilization [ Time Frame: Day 0 to Day 28 ]
    Assessing utilization of hospital resources

  5. Duration of Hospital Resource Utilization [ Time Frame: Day 0 to Day 28 ]
    Assessing duration of hospital resource utilization

  6. 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



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to understand and the willingness to sign a written informed consent document.
  2. Individuals aged ≥ 18 years of all races and ethnic groups.
  3. 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
  4. Not receiving institutional therapy for treatment of SARS-CoV-2, including (but not limited to) remdesivir, chloroquine, hydroxychloroquine, or any other investigational agent(s).
  5. Must meet at least one of the following clinical stratifications:

    1. Have at least 1 minor criterion per ATS criteria (refer to Appendix A), or
    2. Have fever, respiratory symptoms, with pneumonia visible on chest imaging (e.g., X-ray or computed tomography [CT]), or
    3. High risk for poor outcome, as defined by any one of the following:

    i. Age ≥ 60 years old

    ii. Underlying medical comorbidities, defined as:

    • Cardiovascular disease
    • Diabetes
    • 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)

  6. Participants with preexisting auditory damage are allowed.
  7. Participants with a history of epilepsy are allowed.
  8. 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.
  9. FOCBP must agree to use highly-effective method(s) of contraception 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.
  10. Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through at least 1 months after the last dose of study drug.
  11. Participant must agree to not breastfeed during the study or for 30 days after the last dose of study treatment.

Exclusion Criteria:

  1. The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
  2. 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.
  3. 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.
  4. 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
  5. Patients with Myesthenia Gravis or other neuromuscular disorders
  6. Patients with history of psoriasis.

    a. May be waived at the discretion of the PI

  7. Patients with history of porphyria

    a. May be waived at the discretion of the PI

  8. Concomitant use of other antiviral agents for the study's duration, but may be waived at discretion of the Principal Investigator
  9. Hypersensitivity to the study agent, or any of its excipients.
  10. Females who are pregnant or lactating.

Information 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): NCT04363866


Contacts
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Contact: Brett Rodgers 503-494-0076 rodgerbr@ohsu.edu

Locations
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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Contact: Brett Rodgers    503-494-0076    rodgerbr@ohsu.edu   
Principal Investigator: Marcel Curlin, MD         
Sponsors and Collaborators
Oregon Health and Science University
OHSU Knight Cancer Institute
Investigators
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Principal Investigator: Marcel Curlin, MD Oregon Health and Science University
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Responsible Party: Marcel Curlin, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT04363866    
Other Study ID Numbers: STUDY00021303
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after the identification
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months and ending 5 years following article publication
Access Criteria: Anyone who wishes to access the data for any purpose. Data may be obtained by contacting the corresponding author of the relevant publication

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Marcel Curlin, Oregon Health and Science University:
SARS-CoV-2
COVID-19
Hydroxychloroquine
Coronavirus
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents