COVID-19 Clinical Trial
— COVID-19Official 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
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
Status | Recruiting |
Enrollment | 80 |
Est. completion date | September 30, 2020 |
Est. primary completion date | June 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Covidcraz 19, Llc | New Orleans | Louisiana |
United States | Perseverance Research Center | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Perseverance Research Center, LLC | Athena Medical Group |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Time of clinical recovery of fever | 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) | up to 15 days | |
Secondary | Time of clinical recovery of cough | 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 | up to 28 days | |
Secondary | Safety as determined by changes in QTC intervals measured by ECG | to determine the safety of these therapies in combination | up to 15 days | |
Secondary | Safety as determined by presence of side effects | to assess the presence or absence of side effects and whether they are tolerable | up to 15 days | |
Secondary | Time to improvement | 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 | up to 28 days |
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