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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)

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Indomethacin
Zithromax Oral Product
Sponsored by
Perseverance Research Center, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Perseverance Research CenterRecruiting
  • Covidcraz 19, LlcRecruiting

Outcomes

Primary Outcome Measures

Improvement of clinical status
measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free

Secondary Outcome Measures

Time of clinical recovery of fever
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)
Time of clinical recovery of cough
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
Safety as determined by changes in QTC intervals measured by ECG
to determine the safety of these therapies in combination
Safety as determined by presence of side effects
to assess the presence or absence of side effects and whether they are tolerable
Time to improvement
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

Full Information

First Posted
April 8, 2020
Last Updated
June 29, 2020
Sponsor
Perseverance Research Center, LLC
Collaborators
Athena Medical Group
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1. Study Identification

Unique Protocol Identification Number
NCT04344457
Brief Title
Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects With Mild Symptoms of COVID-19
Acronym
COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
June 20, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Perseverance Research Center, LLC
Collaborators
Athena Medical Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open label, single arm study
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
200 mg PO BID 7 days
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Intervention Description
50 mg PO TID 14 Days
Intervention Type
Drug
Intervention Name(s)
Zithromax Oral Product
Intervention Description
500 mg PO QD 3 Days
Primary Outcome Measure Information:
Title
Improvement of clinical status
Description
measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
Time of clinical recovery of fever
Description
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)
Time Frame
up to 15 days
Title
Time of clinical recovery of cough
Description
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
Time Frame
up to 28 days
Title
Safety as determined by changes in QTC intervals measured by ECG
Description
to determine the safety of these therapies in combination
Time Frame
up to 15 days
Title
Safety as determined by presence of side effects
Description
to assess the presence or absence of side effects and whether they are tolerable
Time Frame
up to 15 days
Title
Time to improvement
Description
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
Time Frame
up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 18 years of age Willing and able to provide written informed consent prior to performing study procedures Confirmed Sars-CoV2 infection by PCR Have mild symptoms of Sars-CoV2 Must show documentation of Sars-CoV2 to screening visit Must have had recent hematology and chemistry results Must be able to take heart rate daily Must agree to Skype/Facetime daily Must agree to take temperature daily Must agree not to enroll in another study of an investigational agent prior to completion of Day 14 of treatment. Exclusion Criteria: Known to be allergic to research drugs or drug excipients Incapable of providing informed consent Participation in any other clinical trial of an experimental treatment for Sars-CoV2 infection Pregnancy, possible pregnancy or breast feeding Prolonged QT interval (>450) Moderate to severe symptoms of Sars-CoV2 Renal failure Hepatic failure NSAID use
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole C Hank, PhD,MCR,MHSM
Phone
4804716132
Ext
4804716132
Email
nhank@prcresearcheducation.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Gaither, NP
Organizational Affiliation
Athena Medical Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicole C. Hank, PhD, MCR, MHSM
Organizational Affiliation
Perseverance Research Center
Official's Role
Study Director
Facility Information:
Facility Name
Perseverance Research Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandon McCravey
Phone
480-471-6132
Email
info@prcresearchaz.com
First Name & Middle Initial & Last Name & Degree
Laura Chrisitans
Phone
4804716132
Email
lchristians@prcresearcheducation.com
Facility Name
Covidcraz 19, Llc
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly G Burkenstock, MD
Phone
985-778-9116
Email
kgbmd@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.prcresearchaz.com
Description
Related Info

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

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