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

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ClinicalTrials.gov Identifier: NCT04344457
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : July 1, 2020
Sponsor:
Collaborator:
Athena Medical Group
Information provided by (Responsible Party):
Perseverance Research Center, LLC

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Drug: Indomethacin Drug: Zithromax Oral Product Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label, single arm study
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : June 20, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: Hydroxychloroquine
    200 mg PO BID 7 days
  • Drug: Indomethacin
    50 mg PO TID 14 Days
  • Drug: Zithromax Oral Product
    500 mg PO QD 3 Days

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344457


Contacts
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Contact: Nicole C Hank, PhD,MCR,MHSM 4804716132 ext 4804716132 nhank@prcresearcheducation.com

Locations
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United States, Arizona
Perseverance Research Center Recruiting
Scottsdale, Arizona, United States, 85254
Contact: Brandon McCravey    480-471-6132    info@prcresearchaz.com   
Contact: Laura Chrisitans    4804716132    lchristians@prcresearcheducation.com   
United States, Louisiana
Covidcraz 19, Llc Recruiting
New Orleans, Louisiana, United States, 70124
Contact: Kelly G Burkenstock, MD    985-778-9116    kgbmd@hotmail.com   
Sponsors and Collaborators
Perseverance Research Center, LLC
Athena Medical Group
Investigators
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Principal Investigator: Teresa Gaither, NP Athena Medical Group
Study Director: Nicole C. Hank, PhD, MCR, MHSM Perseverance Research Center
More Information
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Additional Information:

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Responsible Party: Perseverance Research Center, LLC
ClinicalTrials.gov Identifier: NCT04344457    
Other Study ID Numbers: HIZ-PRC-COVID-19
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydroxychloroquine
Azithromycin
Indomethacin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Anti-Bacterial Agents