Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects With Mild Symptoms of COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-16

Study Completion Date

2020-09-30

Brief Summary

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Currently there are no US Food and Drug Administration (FDA)-approved drugs specifically for the treatment of patients with COVID-19. At present, clinical management includes infection prevention and control measures, as well as supportive care, including supplementary oxygen and mechanical ventilatory support when indicated. An array of drugs approved for other indications as well as several investigational drugs are being studied in several hundred clinical trials that are underway across the globe; however, currently there are no clinical trials available to patients in Arizona.

This study will determine if a specific drug cocktail can improve clinical outcomes in patients with confirmed Mild SARS-CoV-2

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Detailed Description

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COVID-19 has become a massive threat to public health worldwide. Current estimates suggest that the novel coronavirus (SARS-CoV-2) is both highly contagious (estimated reproductive rate, 2-3) and five to fifty-fold more lethal than seasonal influenza (estimated mortality rate, 0.5-5%); therefore, interventions to decrease the incidence and severity of COVID-19 are emergently needed. In Maricopa County there has yet to be a clinical trial to evaluate people who are SARS-CoV-2 positive with mild symptoms. This study will measure the improvement of COVID-19 disease status as measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free on 14 days of a cocktail therapy of Hydroxychloroquine, Indomethacin and Zithromax.

Conditions

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COVID-19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label, single arm study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open Label

Interventions

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Hydroxychloroquine

200 mg PO BID 7 days

Intervention Type DRUG

Indomethacin

50 mg PO TID 14 Days

Intervention Type DRUG

Zithromax Oral Product

500 mg PO QD 3 Days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. \> 18 years of age
2. Willing and able to provide written informed consent prior to performing study procedures
3. Confirmed Sars-CoV2 infection by PCR
4. Have mild symptoms of Sars-CoV2
5. Must show documentation of Sars-CoV2 to screening visit
6. Must have had recent hematology and chemistry results
7. Must be able to take heart rate daily
8. Must agree to Skype/Facetime daily
9. Must agree to take temperature daily
10. Must agree not to enroll in another study of an investigational agent prior to completion of Day 14 of treatment.

Exclusion Criteria

1. Known to be allergic to research drugs or drug excipients
2. Incapable of providing informed consent
3. Participation in any other clinical trial of an experimental treatment for Sars-CoV2 infection
4. Pregnancy, possible pregnancy or breast feeding
5. Prolonged QT interval (\>450)
6. Moderate to severe symptoms of Sars-CoV2
7. Renal failure
8. Hepatic failure
9. NSAID use

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No