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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

Tracking Information
First Submitted Date  ICMJE April 8, 2020
First Posted Date  ICMJE April 14, 2020
Last Update Posted Date July 1, 2020
Actual Study Start Date  ICMJE April 16, 2020
Estimated Primary Completion Date June 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
  • 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)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects With Mild Symptoms of COVID-19
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE COVID-19
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date June 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nicole C Hank, PhD,MCR,MHSM 4804716132 ext 4804716132 nhank@prcresearcheducation.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04344457
Other Study ID Numbers  ICMJE HIZ-PRC-COVID-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Perseverance Research Center, LLC
Study Sponsor  ICMJE Perseverance Research Center, LLC
Collaborators  ICMJE Athena Medical Group
Investigators  ICMJE
Principal Investigator: Teresa Gaither, NP Athena Medical Group
Study Director: Nicole C. Hank, PhD, MCR, MHSM Perseverance Research Center
PRS Account Perseverance Research Center, LLC
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP