Phase 2
Completed N=368
University of Utah COVID-19 Hydrochloroquine Trial
coronavirus infection · Coronavirus · Infectious Diseases
Source: ClinicalTrials.gov NCT04342169 ↗
Enrolled (actual)
368
Serious AEs
4.1%
Results posted
Feb 2023
Primary outcomePrimary: Duration of Viral Shedding — 9.532447; 10.39556 Days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Viral Shedding |
9.532447; 10.39556 | — |
| SECONDARY Duration of COVID-19-attributable Symptoms |
6; 6 | — |
| SECONDARY Hospitalization |
7; 4 | — |
| SECONDARY Number of Participants With Viral Shedding on Day 28 |
30; 30 | — |
| SECONDARY Adult Household Contact Viral Acquisition |
16; 19 | — |
Eligibility Criteria
Inclusion Criteria
- Patient age ≥18 years, competent to provide consent
- Within 48 hours of positive nucleic acid test for SARS-CoV-2
Exclusion Criteria
- 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 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
- Patient or another member of patient's household has been already enrolled in this study.
Data sourced from ClinicalTrials.gov (NCT04342169). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.