St Francis Hospital
Roslyn, New York, 11576, United States
NCT Number: NCT04370782
This is a randomized, open-label trial to assess the safety and efficacy of hydroxychloroquine, and zinc in combination with either azithromycin or doxycycline in a higher risk COVID-19 positive outpatient population.
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Notify Me30 year and older
All sexes
Interventional
Phase 4
Roslyn, New York, 11576, United States
COVID-19 is an aggressive and contagious virus, found to have high mortality especially in persons with comorbidities (Age>60, hypertension [HTN], diabetes mellitus [DM], Cancer, and otherwise immunocompromised). Zinc is a supplement with possible antiviral properties, having been shown to have effect in the common cold, many of which are due to coronavirus. In addition, elderly patients and patients with co-morbidities have high incidence of zinc deficiency. We are repleting zinc in all patients and studying its direct effect in combination with hydroxychloroquine, and an antibiotic, either azithromycin or doxycycline to see if there is enhanced treatment efficacy in early COVID-19 infection and assess the safety of these two regimen.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hydroxychloroquine 400mg twice a day (BID) on day 1, followed by 200mg BID for days 2-5
Azithromycin 500mg on day 1, followed by 250mg once daily for days 2-5
Zinc sulfate 220mg once daily for 5 days
Doxycycline 200 mg once daily for 5 days
Time frame: Day 5
Patients will be assessed on day 5 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)
Time frame: Day 14
Patients will be assessed on day 14 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)
Time frame: Day 21
Patients will be assessed on day 21 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)
Time frame: 21 days
Number of participants hospitalized and/or requiring repeat ER visits related to COVID-19 complications
Time frame: Until Discharged up to 30 days
If hospitalized, number of participants admitted to the ICU, and number of days in the ICU
Time frame: Until extubated up to 30 days
If placed on ventilator, number of days on a ventilator
Time frame: Day 5, Day 14, and Day 21
Severity of symptoms evaluated at day 5, day 14, and day 21 scored by the participant for feverishness, sore throat, cough, shortness of breath, myalgias. (0 =none; 1 = mild; 2 = moderate; 3 = severe)
Time frame: 21 days
Number of participants with adverse events due to drug regimen
Time frame: Days 1 thru 5, Day 10, Day 21
Assess all patients to evaluate for QTc prolongation >500ms
St. Francis Hospital, New York
Other
A Randomized Study Evaluating the Safety and Efficacy of Hydroxychloroquine and Zinc in Combination With Either Azithromycin or Doxycycline for the Treatment of COVID-19 in the Outpatient Setting
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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