COVID-19Phase 2NCT04458948
Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients
A Phase 2 study testing Hydroxychloroquine and Azithromycin in people with COVID-19, run by University of New Mexico at 1 site in United States.
Trial summary
This research is designed as an open-label,non-comparative prospective trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Hydroxychloroquine and Azithromycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2020to 28 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
About this study
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
This research is designed as an open-label,non-comparative prospective trial.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine, Azithromycin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
AzithromycinDrug
Azithromycin 500 mg, IV or po for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine and Azithromycin | Experimental | All subjects receive Hydroxychloroquine and Azithromycin. Receives: Drug: Hydroxychloroquine; Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start24 Mar 2020
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458948
- Sponsor's protocol ID
- 20-156
- Status last verified
- Aug 2023
- First submitted
- 9 Jun 2020
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04458948
- Acronym / sponsor ID
- 20-156
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine and Azithromycin | Experimental | Drug: Hydroxychloroquine, Drug: AzithromycinAll subjects receive Hydroxychloroquine and Azithromycin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineHydroxychloroquine 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. | Drug | Hydroxychloroquine and Azithromycin |
| AzithromycinAzithromycin 500 mg, IV or po for 5 days | Drug | Hydroxychloroquine and Azithromycin |
Primary outcome
Number of Participants That Had Viral Shedding as Determined by RT-PCR.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine and Azithromycin in people with COVID-19, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Had Viral Shedding as Determined by RT-PCR. (time frame: 14 to 28 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.