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.

Unknown status

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

Eligibility Criteria

Inclusion Criteria:

1. > 18 years of age

2. Willing and able to provide written informed consent prior to performing study

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

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

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
United States

Perseverance Research Center
Scottsdale, Arizona, United States

Covidcraz 19, Llc
New Orleans, Louisiana, United States


Nicole C Hank, PhD,MCR,MHSM
4804716132 - 4804716132

Athena Medical Group
NCT Number
MeSH Terms