Assessing Hydroxychloroquine in Patients With SARS-CoV-2 (COVID-19)

NCT04363866 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00021303
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, double-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.

Conditions

COVID-19; SARS-CoV-2

Keywords

SARS-CoV-2; COVID-19; Hydroxychloroquine; Coronavirus

Outcome Measures

Primary Outcomes (1)

• Clinical Status at Day 5 Assessed by a 6-Point Ordinal Scale

  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 Outcomes (2)

• Number of Participants with Detectable SARS-CoV-2 Virus from Day 0 to Day 28 and at Day 5

  Day 0 to Day 28 and at Day 5

• Toxicity of Study Drug Assessed by Incidence of Adverse Events

  Day 0 to Day 28

Other Outcomes (6)

• Duration of Initial Hospitalization

  Day 0 to Day 28

• Mortality During Follow-Up

  Day 0 to Day 28

• Mortality During Initial Hospitalization

  Day 0 to Day 28

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

400 mg bid (PO) Day 1, followed by 200 mg bid (PO) Day 2 through Day 5

Drug: Hydroxychloroquine

Placebo

PLACEBO COMPARATOR

Placebo pill bid (PO) Day 1 through Day 5 of the treatment period

Drug: Placebo

Interventions

Hydroxychloroquine DRUG

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

Hydroxychloroquine

Placebo DRUG

A placebo is a pill that looks like the study drug but has no real medicine in it.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• OHSU Knight Cancer Institute: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Marcel Curlin, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded Study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 27, 2020
• Study Start: August 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 29, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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

Locations

US (1)