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Completed

NCT Number: NCT04370782

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

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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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St Francis Hospital

Roslyn, New York, 11576, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydroxychloroquine

Drug

Hydroxychloroquine 400mg twice a day (BID) on day 1, followed by 200mg BID for days 2-5

Azithromycin

Drug

Azithromycin 500mg on day 1, followed by 250mg once daily for days 2-5

zinc sulfate

Drug

Zinc sulfate 220mg once daily for 5 days

Doxycycline

Drug

Doxycycline 200 mg once daily for 5 days

Primary outcomes

  1. Time to Resolution of Symptoms relative to baseline (day 1 of trial)

    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)

  2. Time to Resolution of Symptoms relative 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)

  3. 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)

  4. 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

  5. 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

  6. Ventilator

    Time frame: Until extubated up to 30 days

    If placed on ventilator, number of days on a ventilator

Secondary outcomes

  1. Severity of symptoms

    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)

  2. Number of participants with adverse events due to drug regimen

    Time frame: 21 days

    Number of participants with adverse events due to drug regimen

  3. Number of participants with QTc prolongation >500ms

    Time frame: Days 1 thru 5, Day 10, Day 21

    Assess all patients to evaluate for QTc prolongation >500ms

Sponsors and collaborators

Lead sponsor

St. Francis Hospital, New York

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 1, 2020
Registry last updated
Dec 9, 2020

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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