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
Overview
- Phase
- Phase 4
- Intervention
- Doxycycline
- Conditions
- COVID-19
- Sponsor
- St. Francis Hospital, New York
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Time to Resolution of Symptoms relative to baseline (day 1 of trial)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Avni Thakore MD
Principal Investigator
St. Francis Hospital, New York
Eligibility Criteria
Inclusion Criteria
- •Able to read and understand informed consent.
- •High initial clinical suspicion by physician based on signs and symptoms (fever, cough, myalgias, fatigue, shortness of breath) followed by RT-PCR for confirmation of COVID-19 diagnosis
- •Any gender
- •Age 60 years and older
- •Age 30-59 years with one or more of the following:
- •abnormal lung exam
- •abnormal oxygen staturation \<95%
- •abnormal chest x-ray or chest CT
- •persistent fever \>100.4 degrees Fahrenheit upon arrival to Emergency department (ED)
- •one of the following co-morbidities: hypertension, diabetes mellitus, history of coronary artery disease, chronic kidney disease (CKD), asthma, chronic obstructive pulmonary disease, current or former smoker, or morbid obesity (Body Mass Index ≥35)
Exclusion Criteria
- •Pregnant or breastfeeding female
- •Severe COVID-19 requiring admission for inpatient treatment
- •Need for any oxygen supplementation
- •Need for mechanical ventilatory support
- •History of oxygen supplementation dependency
- •History of cancer with ongoing chemotherapy or radiation therapy
- •Concurrent antimicrobial therapy
- •Known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds
- •Already taking hydroxychloroquine or chloroquine within 1 month
- •Known G6-PD deficiency
Arms & Interventions
Experimental Arm 2
Hydroxychloroquine Doxycycline Zinc sulfate
Intervention: Doxycycline
Experimental Arm 1
Hydroxychloroquine Azithromycin Zinc sulfate
Intervention: Hydroxychloroquine
Experimental Arm 1
Hydroxychloroquine Azithromycin Zinc sulfate
Intervention: Azithromycin
Experimental Arm 1
Hydroxychloroquine Azithromycin Zinc sulfate
Intervention: Zinc Sulfate
Experimental Arm 2
Hydroxychloroquine Doxycycline Zinc sulfate
Intervention: Hydroxychloroquine
Experimental Arm 2
Hydroxychloroquine Doxycycline Zinc sulfate
Intervention: Zinc Sulfate
Outcomes
Primary Outcomes
Time to Resolution of Symptoms relative 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)
Number of participants hospitalized and/or requiring repeat ER visits
Time Frame: 21 days
Number of participants hospitalized and/or requiring repeat ER visits related to COVID-19 complications
ICU Length of Stay
Time Frame: Until Discharged up to 30 days
If hospitalized, number of participants admitted to the ICU, and number of days in the ICU
Ventilator
Time Frame: Until extubated up to 30 days
If placed on ventilator, number of days on a ventilator
Secondary Outcomes
- Severity of symptoms(Day 5, Day 14, and Day 21)
- Number of participants with adverse events due to drug regimen(21 days)
- Number of participants with QTc prolongation >500ms(Days 1 thru 5, Day 10, Day 21)