Trial Outcomes & Findings for Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients (NCT NCT04458948)
NCT ID: NCT04458948
Last Updated: 2023-09-13
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
14 to 28 days.
Results posted on
2023-09-13
Participant Flow
Participant milestones
| Measure |
Hydroxychloroquine and Azithromycin
All subjects receive Hydroxychloroquine and Azithromycin.
Hydroxychloroquine: 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.
Azithromycin: Azithromycin 500 mg, IV or po for 5 days
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ICU Patients in Our Quarterary Care
n=28 Participants
28 individuals admitted with severe COVID-19 pneumonia.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=28 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=28 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=28 Participants
|
|
Age, Continuous
|
70 years
n=28 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=28 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: 14 to 28 days.Population: 28 patients all had COVID -19 pneumonia.
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.
Outcome measures
| Measure |
Hydroxychloroquine and Azithromycin
n=28 Participants
All subjects receive Hydroxychloroquine and Azithromycin.
Hydroxychloroquine: 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.
Azithromycin: Azithromycin 500 mg, IV or po for 5 days
|
|---|---|
|
Number of Participants That Had Viral Shedding as Determined by RT-PCR.
|
6 Participants
|
Adverse Events
Hydroxychloroquine and Azithromycin
Serious events: 9 serious events
Other events: 0 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Hydroxychloroquine and Azithromycin
n=28 participants at risk
All subjects receive Hydroxychloroquine and Azithromycin.
Hydroxychloroquine: 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.
Azithromycin: Azithromycin 500 mg, IV or po for 5 days
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Clotting to vital organs (lungs, heart, kidney and brain)
|
32.1%
9/28 • Number of events 9 • Days 1-5 of admission.
Adverse events were not related to drug intervention.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place