COVID-19
Conditions
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.
Interventions
DRUGHydroxychloroquine
200 mg PO BID 7 days
DRUGIndomethacin
50 mg PO TID 14 Days
DRUGZithromax Oral Product
500 mg PO QD 3 Days
Sponsors
Athena Medical Group
Perseverance Research Center, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Intervention model description
Open label, single arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of clinical status | up to 28 days | measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of clinical recovery of fever | up to 15 days | the time of normalization of fever as measured by daily temperature ( - ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic) |
| Time of clinical recovery of cough | up to 28 days | the time of alleviation of cough as measured by self reported visual analog scale (VAS) cough scale. 1=no cough, 2-3=cough sometimes, 4-6=have a cough but can still do things, 7-8=persistent cough, prevents from doing things, 9-10=cough presents a great deal of discomfort |
| Safety as determined by changes in QTC intervals measured by ECG | up to 15 days | to determine the safety of these therapies in combination |
| Safety as determined by presence of side effects | up to 15 days | to assess the presence or absence of side effects and whether they are tolerable |
| Time to improvement | up to 28 days | improvement in Wisconsin Upper Respiratory Symptom Survey (WURSS-44) 0 to 7 scale, with 0 = Do not have, 1 = Very mild, 3 = Mild, 5 = Moderate, 7 = Severe |
Countries
United States
Contacts
Primary ContactNicole C Hank, PhD,MCR,MHSM
Outcome results
None listed