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

Phase 2

Terminated

• Conditions: COVID-19
• Interventions: Drug: Hydroxychloroquine; Drug: Azithromycin

• Registration Number: NCT04458948
• Lead Sponsor: University of New Mexico

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.

Study Timeline

• Study Start: 2020-03-24
• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-07
• Primary Completion: 2020-08-28
• Study Completion: 2020-08-28
• Results First Submitted: 2023-05-16
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-23
• Last Update Submitted: 2023-08-23
• Results First Posted: 2023-09-13
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. 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.
2. Patient with life expectancy >48 hours.
3. 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.
4. 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
5. 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.

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Exclusion Criteria

1. Prisoners

2. 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.

3. Weight <40 kg.

4. Current use of: hydrocholoroquine or cardiac medicines of: flecainade, Tambocor; amiodarone Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan,Procanbid, propafenone, Rythmal.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydroxychloroquine and Azithromycin	Hydroxychloroquine	All subjects receive Hydroxychloroquine and Azithromycin.
Hydroxychloroquine and Azithromycin	Azithromycin	All subjects receive Hydroxychloroquine and Azithromycin.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Had Viral Shedding as Determined by RT-PCR.	14 to 28 days.	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.

Trial Locations

Locations (1)

University of New Mexico Health Sciences Center; 🇺🇸 Albuquerque, New Mexico, United States