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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.
Layout table for study informationStudy 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 |
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 |
:
Patients will be assessed on day 5 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)
Patients will be assessed on day 14 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)
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 related to COVID-19 complications
If hospitalized, number of participants admitted to the ICU, and number of days in the ICU
If placed on ventilator, number of days on a ventilator
:
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)
Number of participants with adverse events due to drug regimen
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:
Age 30-59 years with one or more of the following:
Exclusion Criteria:
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
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
Layout table for investigator informationPrincipal Investigator: | Avni Thakore, MD | Saint Francis Memorial Hospital |
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 |
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:
Layout table for MeSH terms
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 |