Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients

Study Overview
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Brief Summary
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This research is designed as an open-label,non-comparative prospective trial.

Detailed Description
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxychloroquine and Azithromycin<br>All subjects receive Hydroxychloroquine and Azithromycin. | Drug: Hydroxychloroquine<br>* 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.<br>Drug: Azithromycin<br>* Azithromycin 500 mg, IV or po for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 to 28 days. |