Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting - Full Text View - ClinicalTrials.gov

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ClinicalTrials.gov Identifier: NCT04370782
Recruitment Status

: Not yet recruiting

First Posted : May 1, 2020

Last Update Posted : May 1, 2020

Sponsor:

Information provided by (Responsible Party):

Avni Thakore MD, St. Francis Hospital, New York

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.


COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin Drug: Zinc Sulfate Drug: Doxycycline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : April 28, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020
Resource links provided by the National Library of Medicine
Experimental: Experimental Arm 1

Hydroxychloroquine

Azithromycin

Zinc sulfate

Drug: Hydroxychloroquine

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


Drug: Azithromycin

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


Drug: Zinc Sulfate

Zinc sulfate 220mg once daily for 5 days


Experimental: Experimental Arm 2

Hydroxychloroquine

Doxycycline

Zinc sulfate

Drug: Hydroxychloroquine

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


Drug: Zinc Sulfate

Zinc sulfate 220mg once daily for 5 days


Drug: Doxycycline

Doxycycline 200 mg once daily for 5 days





Primary Outcome Measures

:

  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 Outcome Measures

:

  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




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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370782



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St Francis Hospital
Roslyn, New York, United States, 11576
Contact: Elizabeth Haag, RN    516-622-4512    elizabeth.haag@chsli.org   

St. Francis Hospital, New York

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Principal Investigator: Avni Thakore, MD Saint Francis Memorial Hospital

Yao X, Ye F, Zhang M, Cui C, Huang B, Niu P, Liu X, Zhao L, Dong E, Song C, Zhan S, Lu R, Li H, Tan W, Liu D. In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2020 Mar 9. pii: ciaa237. doi: 10.1093/cid/ciaa237. [Epub ahead of print] Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Dupont HT, Honoré S, Colson P, Chabrière E, La Scola B, Rolain JM, Brouqui P, Raoult D. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Mar 20:105949. doi: 10.1016/j.ijantimicag.2020.105949. [Epub ahead of print] Kim AHJ, Sparks JA, Liew JW, Putman MS, Berenbaum F, Duarte-García A, Graef ER, Korsten P, Sattui SE, Sirotich E, Ugarte-Gil MF, Webb K, Grainger R; COVID-19 Global Rheumatology Alliance†. A Rush to Judgment? Rapid Reporting and Dissemination of Results and Its Consequences Regarding the Use of Hydroxychloroquine for COVID-19. Ann Intern Med. 2020 Mar 30. doi: 10.7326/M20-1223. [Epub ahead of print] Wu C, Liu Y, Yang Y, Zhang P, Zhong W, Wang Y, Wang Q, Xu Y, Li M, Li X, Zheng M, Chen L, Li H. Analysis of therapeutic targets for SARS-CoV-2 and discovery of potential drugs by computational methods. Acta Pharm Sin B. 2020 Feb 27. doi: 10.1016/j.apsb.2020.02.008. [Epub ahead of print]
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Responsible Party: Avni Thakore MD, Principal Investigator, St. Francis Hospital, New York
ClinicalTrials.gov Identifier: NCT04370782    
Other Study ID Numbers: 20-21
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Avni Thakore MD, St. Francis Hospital, New York:

coronavirus
hydroxychloroquine
zinc sulfate

Additional relevant MeSH terms:

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Azithromycin
Doxycycline
Hydroxychloroquine
Zinc Sulfate
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Astringents
Physiological Effects of Drugs
Dermatologic Agents


https://clinicaltrials.gov/ct2/show/NCT04370782