Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects With Mild Symptoms of COVID-19
COVID-19
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
1 other identifier
interventional
80
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 covid19
Started Apr 2020
Shorter than P25 for phase_1 covid19
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2020
CompletedFirst Posted
Study publicly available on registry
April 14, 2020
CompletedStudy Start
First participant enrolled
April 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedJuly 1, 2020
June 1, 2020
2 months
April 8, 2020
June 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement of clinical status
measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free
up to 28 days
Secondary Outcomes (5)
Time of clinical recovery of fever
up to 15 days
Time of clinical recovery of cough
up to 28 days
Safety as determined by changes in QTC intervals measured by ECG
up to 15 days
Safety as determined by presence of side effects
up to 15 days
Time to improvement
up to 28 days
Interventions
Eligibility Criteria
You may qualify if:
- \> 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Perseverance Research Center, LLClead
- Athena Medical Groupcollaborator
Study Sites (2)
Perseverance Research Center
Scottsdale, Arizona, 85254, United States
Covidcraz 19, Llc
New Orleans, Louisiana, 70124, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Teresa Gaither, NP
Athena Medical Group
- STUDY DIRECTOR
Nicole C. Hank, PhD, MCR, MHSM
Perseverance Research Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open Label
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2020
First Posted
April 14, 2020
Study Start
April 16, 2020
Primary Completion
June 20, 2020
Study Completion
September 30, 2020
Last Updated
July 1, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share