University of Utah COVID-19 Hydrochloroquine Trial

NCT04342169 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB_00131893
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

Brief Summary

A novel coronavirus, SARS-CoV-2, is responsible for a rapidly spreading pandemic that has reached 160 countries, infecting over 500,000 individuals and killing more than 24,000 people. SARS-CoV-2 causes an acute and potentially lethal respiratory illness, known as COVID-19, that is threatening to overwhelm health care systems due to a dramatic surge in hospitalized and critically ill patients. Patients hospitalized with COVID-19 typically have been symptomatic for 5-7 days prior to admission, indicating that there is a window during which an effective intervention could significantly alter the course of illness, lessen disease spread, and alleviate the stress on hospital resources. There is no known treatment for COVID-19, though in vitro and one poorly controlled study have identified a potential antiviral activity for HCQ. The rationale for this clinical trial is to measure the efficacy and safety of hydroxychloroquine for reducing viral load and shedding in adult outpatients with confirmed COVID-19.

Conditions

Coronavirus Infection; Coronavirus; Infectious Disease

Keywords

coronavirus; COVID-19; hydrochloroquine; placebo

Outcome Measures

Primary Outcomes (1)

• Duration of Viral Shedding

  Duration of viral shedding, as defined by time from randomization to the first of two consecutive negative swabs, measured on days 1 - 14.

  Days

Secondary Outcomes (4)

• Duration of COVID-19-attributable Symptoms

  Days 1-15

• Hospitalization

  within 14 days of enrollment

• Number of Participants With Viral Shedding on Day 28

  Day 28

• Adult Household Contact Viral Acquisition

  Days 1-14

Study Arms (2)

HCQ

EXPERIMENTAL

Participants randomized to the HCQ arm will receive HCQ 400mg po BID x 1 day, then 200mg po BID x 4 days. The drug dose (2.4 gm over 5 days) falls at the lower end of doses proposed in various international trials, but it has proven in vitro efficacy, with a ratio of lung tissue trough concentrations to the EC50 (effective concentration to suppress 50% of viral activity) of \>20.

Drug: Hydroxychloroquine

Placebo

PLACEBO COMPARATOR

Those randomized to placebo will receive a placebo to be taken on the same schedule.

Drug: Placebo oral tablet

Interventions

Hydroxychloroquine DRUG

HCQ 400mg po BID x 1 day, then 200mg po BID x 4 days

HCQ

Placebo oral tablet DRUG

Placebo to be taken on the same schedule as HCQ.

Placebo

Eligibility Criteria

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

You may qualify if:

• Patient age ≥18 years, competent to provide consent
• Within 48 hours of positive nucleic acid test for SARS-CoV-2

You may not qualify if:

• Patient already prescribed chloroquine or hydroxychloroquine
• Allergy to hydroxychloroquine
• History of bone marrow or solid organ transplant
• Known G6PD deficiency
• Chronic hemodialysis, peritoneal dialysis, continuous renal replacement therapy or Glomerular Filtration Rate \< 20ml/min/1.73m2
• Known liver disease (e.g. Child Pugh score ≥ B or AST\>2 times upper limit)
• Psoriasis
• Porphyria
• Known cardiac conduction delay (QTc \> 500mSec) or taking any prescription medications known to prolong QT interval
• Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone
• Seizure disorder
• Prisoner
• Weight \< 35kg
• Inability to follow-up - no cell phone or no address or not Spanish or English speaking
• Receipt of any experimental treatment for SARS-CoV-2 (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; Communicable Diseases; COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Adam Spivak
• Organization: University of Utah School of Medicine Division of Infectious Diseases

adam.spivak@hsc.utah.edu

8015871964

Study Officials

• Adam Spivak, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Phase 2, prospective, placebo-controlled, parallel group, randomized trial

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: April 4, 2020
• Primary Completion: October 30, 2021
• Study Completion: November 15, 2021
• Last Updated: February 15, 2023
• Results First Posted: February 15, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)