COVID-19Phase 2NCT04358068
Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19
A Phase 2 study testing Hydroxychloroquine (HCQ) and Azithromycin (Azithro) in people with COVID-19 and SARS-CoV 2, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in United States.
Trial summary
The purpose of this study was to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV 2
- What is being tested?
- Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 11 sitesUnited States
- Study dates
- 13 May 2020to 8 Jul 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
- Documentation of confirmed active severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection from any respiratory specimen collected ≤7 days from when the first dose of study treatment was expected to be taken.
- Experienced at least one of the following SARS-CoV-2 infection symptoms within 24 hours of screening (symptom(s) must be new or worse compared to pre-COVID-19 health status):
- Fever (can be subjective) or feeling feverish
- Cough
- Shortness of breath or difficulty breathing at rest or with exertion
- Sore throat
Show all 11Show fewer
- Body pain or muscle pain
- Fatigue
- Headache
- Agreed to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period up until reaching hospitalization or 20 days, whichever is earliest.
- Agreed to not obtain study medications outside of the A5395 study.
Who cannot join
- Need for hospitalization or immediate medical attention in the clinical opinion of the study investigator.
- History of or current hospitalization for COVID-19.
- History of ventricular arrhythmia or use of antiarrhythmics within 30 days prior to entry.
- Personal or family history of Long QT syndrome.
- History of kidney disease.
- History of ischemic or structural heart disease.
Show all 27Show fewer
- History of hypokalemia or hypomagnesemia or taking potassium supplementation or magnesium supplementation
- Personal medical history of porphyria, retinopathy, severe hepatic impairment, or glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Used drugs with possible anti-SARS-CoV-2 activity within 30 days prior to study entry, e.g., remdesivir, lopinavir/ritonavir fixed dose combination, ribavirin, chloroquine, hydroxychloroquine, and azithromycin, or participation in a clinical trial involving any of these drugs whether for treatment or prophylaxis.
- Requirement or expected requirement for a medication that significantly prolongs QT intervals or increases risk for QT prolongation.
- Loop diuretics are exceptions to above exclusion criterion but these cannot be used within 30 days prior to study entry.
- Participated in a study where co-enrollment was not allowed.
- Receipt of a SARS-CoV-2 vaccination prior to study entry.
- Known allergy/sensitivity or any hypersensitivity to components of HCQ, azithromycin, or their formulation.
- More than 10 days of any of the following symptoms attributed to the SARS-CoV-2 infection at study entry:
- Fever (can be subjective) or feeling feverish
- Cough
- Shortness of breath or difficulty breathing at rest or with exertion
- Sore throat
- Body pain or muscle pain
- Fatigue
- Headache
- Chills
- Nasal obstruction or congestion
- Loss of taste or smell
- Nausea or vomiting
- Diarrhea
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Alabama CRS
Birmingham, Alabama, 35294
Northwestern University CRS
Chicago, Illinois, 60611
Rush University CRS
Chicago, Illinois, 60612
Cincinnati Clinical Research Site
Cincinnati, Ohio, 45219
Trinity Health and Wellness Center CRS
Dallas, Texas, 75208
Greensboro CRS
Greensboro, North Carolina, 27401
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, 15213
UCSD Antiviral Research Center CRS
San Diego, California, 92103
University of Washington AIDS CRS
Seattle, Washington, 98104-9929
Harbor-UCLA CRS
Torrance, California, 90502
Whitman-Walker Health CRS
Washington D.C., District of Columbia, 20009
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19
The purpose of this study was to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 infection.
Read the detailed description
This Phase IIB study was designed to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 infection.
Participants were randomized 1:1 to receive active or placebo study treatment. The target sample size was 2000 participants, with approximately 1000 in each arm. Stratification was by "high" versus "low" risk of progression to severe COVID-19, where "high risk" was defined as a person age ≥60 years or having at least one of several specified comorbidities.
Participants were prescribed study treatment for 7 days and were to be followed for an additional 24 weeks. Assessments on a subset of participants were planned to include blood collection, self-collected nasal swabs, and nasopharyngeal swabs.
On June 23, 2020, sites were informed that the study was closing to follow-up due to slow enrollment and lack of community enthusiasm. Follow-up through week 24 was not completed for any participant. Participants were asked to complete the Day 20 visit and then were discontinued from the study. Due to the early termination, enrollment into the specimen collection subset did not occur, and results associated with those specimens are not available. Due to the small number of participants enrolled, some statistical tests were not able to be performed and only descriptive results are provided.
- Conditions
- COVID-19, SARS-CoV 2
- Being tested
- Hydroxychloroquine (HCQ), Azithromycin (Azithro), Placebo for Hydroxychloroquine, Placebo for 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 (HCQ)Drug
Administered orally
Azithromycin (Azithro)Drug
Administered orally
Placebo for HydroxychloroquineDrug
Administered orally
Placebo for AzithromycinDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro) | Experimental | Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days). Receives: Drug: Hydroxychloroquine (HCQ); Drug: Azithromycin (Azithro) |
| Arm B: Placebo for Hydroxychloroquine and Azithromycin | Placebo comparator | Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS:
Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days). Receives: Drug: Placebo for Hydroxychloroquine; Drug: Placebo for Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Died From Any Cause or Were Hospitalized
Hospitalization was defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care was not considered a hospitalization. Formal statistical testing was not conducted due to the small number of participants and events.
Measured: The 20-day period from and including the day of the first dose of study treatment
Secondary outcomes (12)
Number of Participants Who Died From Any Cause
Deaths reported due to any cause (COVID-related or not)
Measured: The 20-day period from and including the day of the first dose of study treatment
Number of Participants Who Died From Any Cause, or Were Hospitalized, or Had an Urgent Visit to Emergency Room or Clinic
Hospitalization was defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care was not considered a hospitalization, but was included for this outcome measure.
Measured: The 20-day period from and including the day of the first dose of study treatment
Number of Participants Who Died From Any Cause or Were Hospitalized Through the End of Follow-up
Hospitalization was defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care was not considered a hospitalization. Due to the early termination of the study, participant followup was discontinued at Day 20. Refer to the primary outcome above for results based on the time frame out to Day 20.
Measured: From day of the first dose of study treatment to Week 24
Number of Participants Who Prematurely Discontinue Study Treatment Due to an Adverse Event
Premature discontinuation of study treatment is defined as a permanent discontinuation of either study treatment (HCQ/Placebo and/or Azithro/Placebo)
Measured: From start of study treatment through Day 7
Number of Participants Who Had Any Cardiac Adverse Events
Cardiac adverse events included in the analysis were chosen a priori by the study chairs
Measured: From start of study treatment through Day 20
Duration of Fever
Defined as the time from study treatment initiation to the last day in the participant's daily diary card on which a temperature greater than 100.4°F was recorded or a potentially antipyretic drug, such as acetaminophen or ibuprofen, was taken. Participants with at least one temperature who never reported fever or use of anti-pyretic medications were assigned a duration of zero days
Measured: Day 0 to Day 20, 21 days total
Duration of Symptoms Associated With COVID-19 Disease
Defined as the time from start of study treatment to the last day in the participant's daily diary card on which a moderate or worse targeted symptom was recorded. The set of target symptoms were cough, shortness of breath, feeling feverish, fatigue, muscle aches, diarrhea, vomiting, nausea, headache, sore throat, nasal obstruction (stuffy nose), nasal discharge (runny nose), loss of smell, and loss of taste. Participants who had missing diary records due to hospitalization were assumed to have moderate symptoms during the period of hospitalization in the analysis. Missing diary card records not due to hospitalization were assumed to have absent symptoms.
Measured: Day 0 to Day 20, 21 days total
Participant-specific Area Under the Curve (AUC) of the Symptom Score Associated With COVID-19 Disease Over Time
Defined as the sum of scores for the targeted symptoms (defined in the protocol) in the participant's daily diary record (each symptom was scored from 0-best to 3-worst). Participant-specific areas under the curve (AUC) over time were calculated using the trapezoidal rule and defined as the area below the line formed by joining total symptom scores on each daily diary card from the pre-treatment score on Day 0 through to Day 20. AUCs were rescaled by time by dividing by 21 (corresponding to the number of daily diary cards during follow-up between pre-treatment Day 0 and Day 20), in order to provide results on a symptom scale from 0-best to 42-worst (for non-hospitalized participants). Participants who were hospitalized were assigned a value equal to the sum of the maximum possible scaled AUC (42) and the duration of hospitalization, and thus values >42 were possible. Missing scores between pre-treatment and Day 20 were linearly interpolated. Higher AUCs indicate worse outcomes.
Measured: Day 0 to Day 20, 21 days total
Time to Self-reported Return to Usual (Pre-COVID) Health.
Time to self-reported return to (pre-COVID) usual health was defined as the time from the start of study treatment to the first day in the participant's daily diary card on which they responded 'Yes' with no subsequent reports of 'No' to the question "Have you returned to your usual (pre-COVID) health today?" Participants who never reported a 'Yes' response were assigned a duration of 22 days.
Measured: Day 0 to Day 20, 21 days total
SARS-CoV-2 RNA Detection Status From Self-collected Nasal and Site-collected NP Swabs Among Subset
The virology substudy did not open to enrollment and thus no data on virologic outcomes are available to report
Measured: Measured at entry, Day 6, and Day 20
SARS-CoV-2 RNA Level (Continuous) From Self-collected Nasal and Site-collected NP Swabs Among Subset
The virology substudy did not open to enrollment and thus no data on virologic outcomes are available to report
Measured: Measured at entry, Day 6, and Day 20
Number of Participants With an Occurrence of Fainting
Fainting was self-reported on the study diary card as absent (score 0), mild (1), moderate (2), or severe (3); scores of > 0 are defined as an occurrence of fainting
Measured: From start of study treatment through Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start13 May 2020
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
Why it stopped: Slow enrollment and lack of community enthusiasm
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.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Teva Pharmaceutical Industries, Ltd.
- Responsible party
- Sponsor
- Investigators
- Davey Smith, MD, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358068
- Sponsor's protocol ID
- ACTG A5395
- Other IDs
- 38720
- Status last verified
- Oct 2021
- First submitted
- 20 Apr 2020
- Last updated
- 16 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19
- ClinicalTrials.gov ID
- NCT04358068
- Acronym / sponsor ID
- ACTG A5395
- Conditions
- COVID-19, SARS-CoV 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment and lack of community enthusiasm
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Teva Pharmaceutical Industries, Ltd.
- Study start
- 13 May 2020 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Posted 1 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 infection.
Detailed description
This Phase IIB study was designed to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 infection.
Participants were randomized 1:1 to receive active or placebo study treatment. The target sample size was 2000 participants, with approximately 1000 in each arm. Stratification was by "high" versus "low" risk of progression to severe COVID-19, where "high risk" was defined as a person age ≥60 years or having at least one of several specified comorbidities.
Participants were prescribed study treatment for 7 days and were to be followed for an additional 24 weeks. Assessments on a subset of participants were planned to include blood collection, self-collected nasal swabs, and nasopharyngeal swabs.
On June 23, 2020, sites were informed that the study was closing to follow-up due to slow enrollment and lack of community enthusiasm. Follow-up through week 24 was not completed for any participant. Participants were asked to complete the Day 20 visit and then were discontinued from the study. Due to the early termination, enrollment into the specimen collection subset did not occur, and results associated with those specimens are not available. Due to the small number of participants enrolled, some statistical tests were not able to be performed and only descriptive results are provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro) | Experimental | Drug: Hydroxychloroquine (HCQ), Drug: Azithromycin (Azithro)Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS: Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days). |
| Arm B: Placebo for Hydroxychloroquine and Azithromycin | Placebo comparator | Drug: Placebo for Hydroxychloroquine, Drug: Placebo for AzithromycinPlacebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS: Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Documentation of confirmed active severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection from any respiratory specimen collected ≤7 days from when the first dose of study treatment was expected to be taken.
- Experienced at least one of the following SARS-CoV-2 infection symptoms within 24 hours of screening (symptom(s) must be new or worse compared to pre-COVID-19 health status):
- Agreed to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period up until reaching hospitalization or 20 days, whichever is earliest.
- Agreed to not obtain study medications outside of the A5395 study.
Key exclusion criteria (27 listed)
- Need for hospitalization or immediate medical attention in the clinical opinion of the study investigator.
- History of or current hospitalization for COVID-19.
- History of ventricular arrhythmia or use of antiarrhythmics within 30 days prior to entry.
- Personal or family history of Long QT syndrome.
- History of kidney disease.
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 |
|---|---|---|
| Hydroxychloroquine (HCQ)Administered orally | Drug | Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro) |
| Azithromycin (Azithro)Administered orally | Drug | Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro) |
| Placebo for HydroxychloroquineAdministered orally | Drug | Arm B: Placebo for Hydroxychloroquine and Azithromycin |
| Placebo for AzithromycinAdministered orally | Drug | Arm B: Placebo for Hydroxychloroquine and Azithromycin |
Primary outcome
Number of Participants Who Died From Any Cause or Were Hospitalized
Time frame: The 20-day period from and including the day of the first dose of study treatment
Hospitalization was defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care was not considered a hospitalization. Formal statistical testing was not conducted due to the small number of participants and events.
12 secondary outcomes
Number of Participants Who Died From Any Cause
Time frame: The 20-day period from and including the day of the first dose of study treatment
Number of Participants Who Died From Any Cause, or Were Hospitalized, or Had an Urgent Visit to Emergency Room or Clinic
Time frame: The 20-day period from and including the day of the first dose of study treatment
Number of Participants Who Died From Any Cause or Were Hospitalized Through the End of Follow-up
Time frame: From day of the first dose of study treatment to Week 24
Number of Participants Who Prematurely Discontinue Study Treatment Due to an Adverse Event
Time frame: From start of study treatment through Day 7
Number of Participants Who Had Any Cardiac Adverse Events
Time frame: From start of study treatment through Day 20
Duration of Fever
Time frame: Day 0 to Day 20, 21 days total
Duration of Symptoms Associated With COVID-19 Disease
Time frame: Day 0 to Day 20, 21 days total
Participant-specific Area Under the Curve (AUC) of the Symptom Score Associated With COVID-19 Disease Over Time
Time frame: Day 0 to Day 20, 21 days total
Time to Self-reported Return to Usual (Pre-COVID) Health.
Time frame: Day 0 to Day 20, 21 days total
SARS-CoV-2 RNA Detection Status From Self-collected Nasal and Site-collected NP Swabs Among Subset
Time frame: Measured at entry, Day 6, and Day 20
SARS-CoV-2 RNA Level (Continuous) From Self-collected Nasal and Site-collected NP Swabs Among Subset
Time frame: Measured at entry, Day 6, and Day 20
Number of Participants With an Occurrence of Fainting
Time frame: From start of study treatment through Day 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017)Link provided by the sponsor.
- Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.
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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.
Davey Smith, MD study chair
University of California, San Diego
11 sites 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 (HCQ) and Azithromycin (Azithro) in people with COVID-19 and SARS-CoV 2, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites 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 11 inclusion and 27 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 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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. Some participants in this study may receive a placebo. 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 1 Apr 2021). 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 Who Died From Any Cause or Were Hospitalized (time frame: The 20-day period from and including the day of the first dose of study treatment). 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 16 Nov 2021.