Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting

• Status: Completed
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Francis Hospital, New York
• Treatments: Azithromycin; Doxycycline; Hydroxychloroquine; Zinc Sulfate

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

• 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.