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

June 29, 2020 updated by: Perseverance Research Center, LLC

An Open-Label, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects Positive With SARS-CoV-2 With Mild Symptoms

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
    • Louisiana
      • New Orleans, Louisiana, United States, 70124
        • Recruiting
        • Covidcraz 19, Llc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of clinical status
Time Frame: up to 28 days
measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free
up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of clinical recovery of fever
Time Frame: up to 15 days
the time of normalization of fever as measured by daily temperature ( - ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic)
up to 15 days
Time of clinical recovery of cough
Time Frame: up to 28 days
the time of alleviation of cough as measured by self reported visual analog scale (VAS) cough scale. 1=no cough, 2-3=cough sometimes, 4-6=have a cough but can still do things, 7-8=persistent cough, prevents from doing things, 9-10=cough presents a great deal of discomfort
up to 28 days
Safety as determined by changes in QTC intervals measured by ECG
Time Frame: up to 15 days
to determine the safety of these therapies in combination
up to 15 days
Safety as determined by presence of side effects
Time Frame: up to 15 days
to assess the presence or absence of side effects and whether they are tolerable
up to 15 days
Time to improvement
Time Frame: up to 28 days
improvement in Wisconsin Upper Respiratory Symptom Survey (WURSS-44) 0 to 7 scale, with 0 = Do not have, 1 = Very mild, 3 = Mild, 5 = Moderate, 7 = Severe
up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perseverance Research Center, LLC

Collaborators

Athena Medical Group

Investigators

  • Principal Investigator: Teresa Gaither, NP, Athena Medical Group
  • Study Director: Nicole C. Hank, PhD, MCR, MHSM, Perseverance Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2020

Primary Completion (Anticipated)

June 20, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

July 1, 2020

Last Update Submitted That Met QC Criteria

June 29, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIZ-PRC-COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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