Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04590274

Enrollment

Registered

2020-10-19

Start date

2020-11-30

Completion date

2021-12-31

Last updated

2021-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, SARS (Severe Acute Respiratory Syndrome)

Brief summary

Coronavirus Disease 2019 (COVID-19) (previously called 2019-nCOV acute respiratory disease) is caused by SARS-CoV-2, a positive-sense single-stranded RNA virus of the coronavirus family. The coronaviruses are largely responsible for the common cold, the 2002 SARS outbreak in Guangdong, China, the 2012 MERS outbreak in Saudi Arabia, and the present COVID-19 outbreak that originated in Wuhan, China. Much has been reported by way of systemic injury caused by COVID-19 affecting the cardiovascular, hepatic, nervous systems. These conditions are likely the result of the virus overwhelming the immune system. For these reasons, the investigators wish to conduct this study using existing medications off-label, and over-the-counter supplements to support the immune response, prevent lasting injury, and hasten the recovery from COVID-19.

Interventions

DRUGHydroxychloroquine

Hydroxychloroquine

DIETARY_SUPPLEMENTVitamins and Minerals

elemental Zinc Vitamin C Vitamin D3 N-acetylcysteine Elderberry Quercetin

DRUGAzithromycin

Azithromycin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

1\) Patients must have one or more of the following: 1. confirmed diagnosis of active SARS-CoV-2 infection, diagnosed with PCR 2. continued close contact with an individual with suspected SARS-CoV-2 infection 3. at risk for SARS-CoV-2 infection in the opinion of the treating physician or Principal Investigator.

Exclusion criteria

1\) Patients must not have any uncontrolled disease such as: 1. cardiovascular disease 2. hepatic disease 3. renal disease 4. metabolic disease 5. other diseases or insufficiencies

Design outcomes

Primary

Measure	Time frame	Description
Percentage of individuals who develop COVID-19 symptoms	6 months from study start	The investigators will compare what percentage of participants in this study go on to develop COVID-19 symptoms, as compared to individuals not on the medicational regimen in this study.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026