A Phase 1/2 interventional study of Hydroxychloroquine and Indomethacin in COVID-19, sponsored by Perseverance Research Center, LLC. Status unknown at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-01.
Sponsored by Perseverance Research Center, LLC · Phase 1/2, Interventional, and Treatment
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
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Perseverance Research Center, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
200 mg PO BID 7 days
50 mg PO TID 14 Days
500 mg PO QD 3 Days
Improvement of clinical status
measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free
Time frame: up to 28 days
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)
Time frame: up to 15 days
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
Time frame: up to 28 days
Safety as determined by changes in QTC intervals measured by ECG
to determine the safety of these therapies in combination
Time frame: up to 15 days
Safety as determined by presence of side effects
to assess the presence or absence of side effects and whether they are tolerable
Time frame: up to 15 days
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
Time frame: up to 28 days
Plan to share: No
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Perseverance Research Center, LLC