Clinical trial NCT04344457: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: COVID-19
Lead sponsor: Perseverance Research Center, LLC
Sponsor class: OTHER
Collaborators: name: Athena Medical Group
First posted: 2020-04-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, single arm study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement of clinical status
timeFrame: up to 28 days
Secondary outcomes:
measure: Time of clinical recovery of fever
timeFrame: up to 15 days
measure: Time of clinical recovery of cough
timeFrame: up to 28 days
measure: Safety as determined by changes in QTC intervals measured by ECG
timeFrame: up to 15 days
measure: Safety as determined by presence of side effects
timeFrame: up to 15 days
measure: Time to improvement
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Perseverance Research Center
state: Arizona
city: New Orleans
country: United States
facility: Covidcraz 19, Llc
state: Louisiana
Study officials:
affiliation: Athena Medical Group
name: Teresa Gaither, NP
role: PRINCIPAL_INVESTIGATOR
affiliation: Perseverance Research Center
name: Nicole C. Hank, PhD, MCR, MHSM
role: STUDY_DIRECTOR
References: