---
title: Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care
nct_id: NCT04334967
overall_status: SUSPENDED
phase: PHASE4
sponsor: Providence Health & Services
study_type: INTERVENTIONAL
primary_condition: COVID-19
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04334967.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04334967"
ct_last_update_post_date: 2020-09-16
last_seen_at: "2026-05-12T07:19:13.114Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care

**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

**NCT ID:** [NCT04334967](https://clinicaltrials.gov/study/NCT04334967)

## Key Facts

- **Status:** SUSPENDED
- **Why Stopped:** suspected unfavorable risk/benefit assessment
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 13
- **Lead Sponsor:** Providence Health & Services
- **Collaborators:** Center for Outcomes Research and Education, Providence Cancer Center, Earle A. Chiles Research Institute
- **Conditions:** COVID-19, Corona Virus Infection, SARS-CoV-2, 2019-nCoV, 2019 Novel Coronavirus
- **Start Date:** 2020-03-30
- **Completion Date:** 2022-05-27
- **CT.gov Last Update:** 2020-09-16

## 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.

## Eligibility

- **Minimum age:** 45 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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 \<10 ml/min or on hemodialysis (as evidenced in EMR)
* Known G6PD deficiency
* Current use of the following medications: digoxin, amiodarone, flecainide, procainamide, oral dapsone. If other meds of concern, route to pharmacist to evaluate
* Concomitant use of the following only at Pharmacist/Investigator discretion: Abiraterone acetate, agalsidase, conivaptan, dabrafenib, dacomitinib, dapsone (systemic), digoxin, enzalutamide, fexinidazole, flecainide, fusidic acid (systemic), idelalisib, mifepristone, mitotane, pimozide, amiodarone, digoxin, procainamide, propafenone, stiripentol
* Currently on hospice
* Women of childbearing potential must not be pregnant, and must avoid becoming pregnant while on treatment and for 30 days following treatment discontinuation. Men must avoid fathering a child while on treatment and for 30 days following treatment discontinuation
* Any clinical factors such as bleeding, active infection, or psychiatric factors that in the judgment of the investigator would preclude safe participation and compliance with study procedures.
```

## Arms

- **Treatment Arm** (EXPERIMENTAL) — Patients in the treatment arm will receive 200 mg oral hydroxychloroquine. Day 1: 400 mg doses twice (800 mg total). Days 2-5: 200 mg dose twice (400 mg total daily).
- **Control Arm** (ACTIVE_COMPARATOR) — Patients in the control arm will receive 500 mg oral Vitamin C. Day 1: 1000 mg dose twice (2000 mg total) Days 2-5: 500 mg dose twice (1000 mg total daily).

## Interventions

- **Hydroxychloroquine** (DRUG) — 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.
- **Vitamin C** (DIETARY_SUPPLEMENT) — 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.

## Primary Outcomes

- **Total Hospitalization** _(time frame: 14 days)_ — This outcome will be assessed by comparing the percentages of enrolled patients that are hospitalized in the treatment and control arms.
- **Total Mechanical Ventilation** _(time frame: 14 days)_ — This outcome will be assessed by comparing the percentages of enrolled patients that have received mechanical ventilation in the treatment and control arms.

## Secondary Outcomes

- **Fever intensity measure** _(time frame: 2 days)_
- **Fever intensity measure** _(time frame: 5 days)_
- **Fever intensity measure** _(time frame: 10 days)_
- **Fever intensity measure** _(time frame: 14 days)_
- **Shortness of breath measure** _(time frame: 2 days)_
- **Shortness of breath measure** _(time frame: 5 days)_
- **Shortness of breath measure** _(time frame: 10 days)_
- **Shortness of breath measure** _(time frame: 14 days)_
- **Changes in daytime cough measure** _(time frame: 2 days)_
- **Changes in daytime cough measure** _(time frame: 5 days)_
- **Changes in daytime cough measure** _(time frame: 10 days)_
- **Changes in daytime cough measure** _(time frame: 14 days)_
- **Changes in nighttime cough measure** _(time frame: 2 days)_
- **Changes in nighttime cough measure** _(time frame: 5 days)_
- **Changes in nighttime cough measure** _(time frame: 10 days)_
- **Changes in nighttime cough measure** _(time frame: 14 days)_
- **Total mortality** _(time frame: 28 days)_

## Locations (1)

- Portland Providence Medical Center, Portland, Oregon, United States

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.portland providence medical center|portland|oregon|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04334967.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04334967*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*