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

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

Tracking Information

• First Submitted Date: April 8, 2020
• First Posted Date: April 14, 2020
• Last Update Posted Date: July 1, 2020
• Actual Study Start Date: April 16, 2020
• Estimated Primary Completion Date: June 20, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects With Mild Symptoms of 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

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: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

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: COVID-19

Intervention

• 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: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 10, 2020): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2020
• Estimated Primary Completion Date: June 20, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04344457
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Perseverance Research Center, LLC
• 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

• PRS Account: Perseverance Research Center, LLC
• Verification Date: June 2020