Back to resultsNon-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients
Primary Purpose
COVID-19
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Azithromycin
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Adults aged >18 years of age with lower respiratory infection with SARSCo2 documented by a positive RT-PCR in nasopharyngeal sample admitted to the University of New Mexico Hospital, with an oxygen saturation of less than 94%, on room air, or a respiratory rate >24 per minute, or HR>125 per minute of a PaO2/FIO2<150.
- Patient with life expectancy >48 hours.
- Pregnant women may be included if deemed necessary. There is insufficient information regarding the safety of hydroxychloroquine and azithromycin during pregnancy. Consequently, these medications are not recommended when pregnant or planning to become pregnant. However, investigators may prescribe hydroxychloroquine and azithromycin if deemed necessary.
- Azithromycin is excreted in human milk, therefore participants should not breast-feed whilst taking Azithromycin, because it may cause side effects including diarrhoea and infection to a baby. It is recommended to discard the milk during treatment and up until 2 days after discontinuation of treatment. Additionally, hydroxychloroquine should not be taken whilst breast-feeding. However, investigators may prescribe hydroxychloroquine and azithromycin if deemed necessary. Page 6 of 23 Version Date: 04.16.2020
- Adults unable to consent will be included with the consent of their Legally Authorized Representative (LAR). Assent will be pursued from cognitively impaired participants if they are able to provide assent. Note that this does not preclude the enrollment of cognitively impaired participants that cannot provide assent, but would allow those that can the opportunity to do so.
Exclusion Criteria:
- Prisoners
Pre-/co-existing medical conditions, including any of the following:
Known allergy to study drugs. Contraindication to treatment with study drugs, including retinopathy, and QTc prolongation defined by QTc>450 in males and >470 in females. Unless, it is the opinion of the treating physician(s) that the benefits to treat with medications outweigh the risks. Known chronic kidney disease, stage 4 or 5 or receiving dialysis. Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Weight <40 kg.
- Current use of: hydrocholoroquine or cardiac medicines of: flecainade, Tambocor; amiodarone Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan,Procanbid, propafenone, Rythmal.
Sites / Locations
- University of New Mexico Health Sciences Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hydroxychloroquine and Azithromycin
Arm Description
All subjects receive Hydroxychloroquine and Azithromycin.
Outcomes
Primary Outcome Measures
Number of Participants That Had Viral Shedding as Determined by RT-PCR.
To measure the duration of viral shedding in respiratory secretions of patients with moderate to severe COVID-19 infection treated with the combination of Hydroxychloroquine and azithromycin.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04458948
Brief Title
Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients
Official Title
Open Label Non-comparative Trial of the Combination of Hydroxychloroquine and Azithromycin in the Treatment of Hospitalized Patients With Moderate or Severe COVID-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
The World Health Organization (WHO) paused Hydrochloroquinone from its Solidarity Trial in order to conduct a safety data review by the Data Safety Monitoring Board of the WHO to evaluate HCQ in its clinical trials.
Study Start Date
March 24, 2020 (Actual)
Primary Completion Date
August 28, 2020 (Actual)
Study Completion Date
August 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico
4. Oversight
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
5. Study Description
Brief Summary
This research is designed as an open-label,non-comparative prospective trial.
Detailed Description
The objects of this research are as follows:
(1) To measure the duration of viral shedding in respiratory secretions of patients with moderate or severe COVID-19 infection treated with the combination of Hydroxychloroquine and azithromycin. (2) Evaluate the case fatality rate, the clinical response and length of stay in hospitalized patients with moderate and severe COVID-19 infection. (3) To report the safety of the drug combination in hospitalized patients with moderate and severe COVID-19 infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydroxychloroquine and Azithromycin
Arm Type
Experimental
Arm Description
All subjects receive Hydroxychloroquine and Azithromycin.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Hydroxychloroquine 400 mg BID, on day 1 and then 200 mg BID day 2 through 7 IV or po for 5 days. If the condition of the patient does not allow for oral therapy, HCQ can be given via a feeding or NG tube. Azithromycin can be given intravenously.
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Azithromycin 500 mg, IV or po for 5 days
Primary Outcome Measure Information:
Title
Number of Participants That Had Viral Shedding as Determined by RT-PCR.
Description
To measure the duration of viral shedding in respiratory secretions of patients with moderate to severe COVID-19 infection treated with the combination of Hydroxychloroquine and azithromycin.
Time Frame
14 to 28 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults aged >18 years of age with lower respiratory infection with SARSCo2 documented by a positive RT-PCR in nasopharyngeal sample admitted to the University of New Mexico Hospital, with an oxygen saturation of less than 94%, on room air, or a respiratory rate >24 per minute, or HR>125 per minute of a PaO2/FIO2<150.
Patient with life expectancy >48 hours.
Pregnant women may be included if deemed necessary. There is insufficient information regarding the safety of hydroxychloroquine and azithromycin during pregnancy. Consequently, these medications are not recommended when pregnant or planning to become pregnant. However, investigators may prescribe hydroxychloroquine and azithromycin if deemed necessary.
Azithromycin is excreted in human milk, therefore participants should not breast-feed whilst taking Azithromycin, because it may cause side effects including diarrhoea and infection to a baby. It is recommended to discard the milk during treatment and up until 2 days after discontinuation of treatment. Additionally, hydroxychloroquine should not be taken whilst breast-feeding. However, investigators may prescribe hydroxychloroquine and azithromycin if deemed necessary. Page 6 of 23 Version Date: 04.16.2020
Adults unable to consent will be included with the consent of their Legally Authorized Representative (LAR). Assent will be pursued from cognitively impaired participants if they are able to provide assent. Note that this does not preclude the enrollment of cognitively impaired participants that cannot provide assent, but would allow those that can the opportunity to do so.
Exclusion Criteria:
Prisoners
Pre-/co-existing medical conditions, including any of the following:
Known allergy to study drugs. Contraindication to treatment with study drugs, including retinopathy, and QTc prolongation defined by QTc>450 in males and >470 in females. Unless, it is the opinion of the treating physician(s) that the benefits to treat with medications outweigh the risks. Known chronic kidney disease, stage 4 or 5 or receiving dialysis. Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Weight <40 kg.
Current use of: hydrocholoroquine or cardiac medicines of: flecainade, Tambocor; amiodarone Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan,Procanbid, propafenone, Rythmal.
Facility Information:
Facility Name
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients
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