Status:
COMPLETED
Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting
Lead Sponsor:
St. Francis Hospital, New York
Conditions:
COVID-19
Eligibility:
All Genders
30+ years
Phase:
PHASE4
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 outpa...
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 im...
Eligibility Criteria
Inclusion
- 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
- 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
- History of retinopathy
- History of current cardiac diseases (heart failure, ventricular arrhythmias, Left bundle branch block and/or Right bundle branch block, QTc prolongation \>480ms), or family history of sudden cardiac death
- Ongoing use of drugs that prolong the QTc interval (antipsychotics, antidepressants, class I and III antiarrhythmics, triptans)
- Severe renal disease: glomerular filtration rate (GFR) \<30ml/min
- Severe hepatic impairment (elevated total bilirubin \>2 mg/dL, decreased albumin \<2.8 g/dL, signs of jaundice and ascites.)
- Active alcohol abuse (\>5 drinks per day or \>20 drinks per week.)
- Seizure disorder, currently on medications
- Known hypersensitivity to any tetracyclines.
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04370782
Start Date
April 28 2020
End Date
September 30 2020
Last Update
December 9 2020
Active Locations (1)
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1
St Francis Hospital
Roslyn, New York, United States, 11576