Overview

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

Status:
Recruiting

Trial end date:
2020-09-30

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Perseverance Research Center, LLC

Collaborator:

Athena Medical Group

Treatments:

Azithromycin
Hydroxychloroquine
Indomethacin

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