Recruiting
Phase 1
Phase 2

Hydroxychloroquine, Indomethacin, Zithromax

Sponsor:

Perseverance Research Center, LLC

Code:

NCT04344457

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hydroxychloroquine

Indomethacin

Zithromax Oral Product

Study Details

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

Conditions

COVID-19

Study ID

NCT04344457

Start date

Apr 16, 2020

Status verified date

Jun, 2020

Completion date

Sep 30, 2020

Anticipated

Primary completion date

Jun 20, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Hydroxychloroquine

200 mg PO BID 7 days

Indomethacin

50 mg PO TID 14 Days

Zithromax Oral Product

500 mg PO QD 3 Days

Primary outcome measure

  • Improvement of clinical status [ Time Frame: up to 28 days ]

Central Contacts and Locations

Central contacts

Nicole C Hank, PhD,MCR,MHSM

4804716132nhank@prcresearcheducation.com

Locations

Perseverance Research Center

Recruiting

Scottsdale, Arizona, United States, 85254

Contacts

Brandon McCravey

480-471-6132info@prcresearchaz.com

Laura Chrisitans

4804716132lchristians@prcresearcheducation.com

Covidcraz 19, Llc

Recruiting

New Orleans, Louisiana, United States, 70124

Contacts

Kelly G Burkenstock, MD

985-778-9116kgbmd@hotmail.com

More Information

Sponsor

Perseverance Research Center, LLC

Last update posted

Jul 1, 2020

Last verified

Jun, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Perseverance Research Center, LLC on 2020-07-01.