Official Title
Randomized Study to Evaluate the Safety and Antiviral Efficacy of Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care Treatment
Brief Summary

This study will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with COVID-19

Detailed Description

Hydroxychloroquine has primarily been raised as a potential treatment of SARS-Cov-2 based on in vitro antiviral activity. A draft paper was released recently in March by Didier Raoult from Aix-Marseille University in France on a preliminary trial of 36 COVID-19 patients. In this trial, 6 patients were asymptomatic, 22 had upper respiratory symptoms, and 8 had lower respiratory symptoms. Between early and mid-March, they treated 20 of these patients with 600 mg of hydroxychloroquine daily in a hospital setting. Some patient also received the antibiotic azithromycin. 16 patients served as the controls. They observed a significant reduction in viral load in patients with hydroxychloroquine. After 6 days, 70% of the treated patients were considered cured (no virus detected in their samples) compared to 12.5% of controls. All 6 patients who received both hydroxychloroquine and azithromycin were negative for the virus after 6 days. This was an unblinded, non-randomized trial.

Vitamin C has multiple in-vivo effects on immune modulation that may, in sum, limit the development of the cytokine excess associated with critical illness. It is currently being studied in a clinical trial as a treatment for severe SARS-CoV-2 pneumonia in China and recommended as a supplement in standard treatment of COVID-19.

There are no medications currently approved for treatment of COVID-19. Hydroxychloroquine is a known drug with low toxicity that may reduce progression of respiratory symptoms and resulting hospitalizations. This randomized control study will assess its potential as an off-label treatment in reducing the rates of hospitalization and subsequent mechanical ventilation from COVID-19 infection compared to standard of care treatment with Vitamin C. A randomized control trial with placebo is impractical due to the increasing availability of this medication to the public.

Enrolling by invitation
COVID-19
Corona Virus Infection
SARS-CoV-2
2019-nCoV
2019 Novel Coronavirus

Drug: Hydroxychloroquine
Treatment arm medication will be administered on an outpatient basis. Due to the emergent health crisis, study drug will be delivered to patients by institution staff or contract courier using a non-contact protocol.
Treatment Arm

Dietary Supplement: Vitamin C
Control arm supplement will be administered on an outpatient basis. Due to the emergent health crisis, study supplies will be delivered to patients by institution staff or contract courier using a non-contact protocol.
Control Arm
Other Name: ascorbic acid

Eligibility Criteria

Inclusion Criteria:

- Must have positive nasopharyngeal swab for SARS-CoV-2 diagnosed via outpatient testing within the previous 48 hours

- Age ≥ 45 years

- Not hospitalized at the time of enrollment

- Established care with Providence provider

- Ability to understand a written or electronic informed consent document

- Reliable access to a computer or smartphone that can facilitate study communications via remote messaging or telephone and willingness to provide daily verbal check ins

Exclusion Criteria:

- Hypersensitivity to chloroquine or hydroxychloroquine

- History of retinal disease (macular degeneration, diabetic retinopathy, retinal rear/detachment, retinitis pigmentosa)

- History of seizure disorder

- History of ventricular tachycardia/fibrillation, history of long-QT syndrome, or ICD

- Current creatinine clearance

Eligibility Gender
All
Eligibility Age
Minimum: 45 Years
Countries
United States
Locations

Portland Providence Medical Center
Portland, Oregon, 97213

Brian Kendal, MD
Principal Investigator
Providence Medical Group Infectious Disease

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Trista Johnson, PhD, MPH
Study Director
Providence Ambulatory Quality and Clinical Services

Providence Health & Services
Center for Outcomes Research and Education
Providence Cancer Center, Earle A. Chiles Research Institute
NCT Number
MeSH Terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Ascorbic Acid
Hydroxychloroquine