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

Sponsor

Perseverance Research Center, LLC (Other)

Overall Status

Unknown status

CT.gov ID

NCT04344457

Collaborator

Athena Medical Group (Other)

Enrollment

Locations

5.5

Anticipated Duration (Months)

Patients Per Site

7.3

Patients Per Site Per Month

Study Details

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

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

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open label, single arm studyOpen 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 :

Apr 16, 2020

Anticipated Primary Completion Date :

Jun 20, 2020

Anticipated Study Completion Date :

Sep 30, 2020

Outcome Measures

Primary Outcome Measures

Improvement of clinical status [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

Time of clinical recovery of fever [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 [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 [up to 15 days]
to determine the safety of these therapies in combination
Safety as determined by presence of side effects [up to 15 days]
to assess the presence or absence of side effects and whether they are tolerable
Time to improvement [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Perseverance Research Center	Scottsdale	Arizona	United States	85254
2	Covidcraz 19, Llc	New Orleans	Louisiana	United States	70124

Sponsors and Collaborators

Perseverance Research Center, LLC
Athena Medical Group

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Perseverance Research Center, LLC

ClinicalTrials.gov Identifier:

NCT04344457

Other Study ID Numbers:

HIZ-PRC-COVID-19

First Posted:

Apr 14, 2020

Last Update Posted:

Jul 1, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2020