Coronavirus InfectionPhase 3WU352NCT04341727
Hydroxychloroquine,Hydroxychloroquine,Azithromycin in the Treatment of SARS CoV-2 Infection
A Phase 3 study testing Hydroxychloroquine Sulfate, Azithromycin and Chloroquine Sulfate in people with Coronavirus Infection, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring intensive care unit (ICU) admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- Hydroxychloroquine Sulfate, Azithromycin and Chloroquine Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Apr 2020to 1 Apr 2021
- Phase
- Phase 3
- 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
- Hospitalization for management of SARS CoV-2 infection
- Positive SARS CoV-2 test
- Age >=18 years
- Provision of informed consent
- Electrocardiogram (ECG) ≤48 hours prior to enrollment
- Complete blood count, glucose-6 phosphate-dehydrogenase (G6PD), comprehensive metabolic panel and magnesium ≤48 hours prior to enrollment from standard of care.
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- If participating in sexual activity that could lead to pregnancy, individuals of reproductive potential who can become pregnant must agree to use contraception throughout the study. At least one of the following must be used throughout the study:
- Condom (male or female) with or without spermicide
- Diaphragm or cervical cap with spermicide
- Intrauterine device (IUD)
- Hormone-based contraceptive
Who cannot join
- Contraindication or allergy to chloroquine, hydroxychloroquine or azithromycin
- Current use hydroxychloroquine, chloroquine or azithromycin
- Concurrent use of another investigational agent
- Invasive mechanical ventilation
- Participants who have any severe and/or uncontrolled medical conditions such as:
- unstable angina pectoris,
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- symptomatic congestive heart failure,
- myocardial infarction,
- cardiac arrhythmias or know prolonged QTc >470 males, >480 female on ECG
- pulmonary insufficiency,
- epilepsy (interaction with chloroquine),
- Prior retinal eye disease
- Concurrent malignancy requiring chemotherapy
- Known Chronic Kidney disease, eGFR<10 or dialysis
- G-6-PD deficiency, if unknown requires G6PD testing prior to enrollment
- Known Porphyria
- Known myasthenia gravis
- Currently pregnant or planning on getting pregnant while on study
- Breast feeding
- AST/ALT >five times the upper limit of normal ULN*
- Bilirubin >five times the ULN*
- Magnesium <1.4 mEq/L*
- Calcium <8.4mg/dL >10.6mg/dL*
- Potassium <3.3 >5.5 mEg/L*
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Washington University School of Medicine Infectious Disease Clinical Research Unit
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Open-label, Randomized Controlled Trial of Hydroxychloroquine, Hydroxychloroquine Plus Azithromycin, Chloroquine Alone, Chloroquine Plus Azithromycin in the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) Infection
This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring intensive care unit (ICU) admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.
Read the detailed description
This Phase III trial will utilize four treatment strategies in non-critically ill hospitalized participants (not requiring mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin. Investigators are primarily interested in the time to recovery. In addition to study medications there will be daily symptom surveys for 14 days, then weekly thereafter for 4 weeks resulting in a total duration of follow up of 42 days. During hospitalization, daily symptom surveys will be completed in conjunction with the study coordinators. On discharge participants will have the option to complete electronic symptom surveys or complete symptom surveys via telephone with study coordinator. In the event that the participant opts for electronic symptom surveys on discharge participants will in addition receive a follow up call from a study coordination every 7 days during the initial 14 day period. In addition, failure to submit a symptom survey will prompt a study follow up call. Data from standard of care SOC will be collected from medical records.
- Conditions
- Coronavirus Infection
- Being tested
- Hydroxychloroquine Sulfate, Azithromycin, Chloroquine Sulfate
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine SulfateDrug
Also called HYDROXYCHLOROQUINE Plaquenil
anti-rheumatic drug (DMARD)
AzithromycinDrug
Also called COMMON BRAND(S): Zithromax GENERIC NAME(S): Azithromycin
Antibiotic
Chloroquine SulfateDrug
Also called Aralen GENERIC NAME(S): Chloroquine Phosphate
Antimalarial
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine alone | Active comparator | Arm 1: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets. Receives: Drug: Hydroxychloroquine Sulfate |
| Hydroxychloroquine plus azithromycin | Active comparator | Arm 2: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for four consecutive days (five days total). The drug will be supplied in 250mg tablets. Receives: Drug: Hydroxychloroquine Sulfate; Drug: Azithromycin |
| Chloroquine alone | Active comparator | Arm 3: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets. Receives: Drug: Chloroquine Sulfate |
| Chloroquine plus azithromycin | Active comparator | Arm 4: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets.
AND Azithromycin 500mg orally once, followed by 250mg daily for 4 consecutive days (5 days total).The drug will be supplied in 250mg tablets. Receives: Drug: Azithromycin; Drug: Chloroquine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hours to Recovery
Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death in each Arm/Group,respectively.
Measured: 42 days
Secondary outcomes (1)
Time to Fever Resolution
Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications in each Arm/Group,respectively.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start4 Apr 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Why it stopped: DSMB recommended study suspension slow accrual
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 Coronavirus InfectionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane O'Halloran, Washington University School of Medicine
- Investigators
- Jane O'Halloran, MD PhD, Principal investigator, Washington University School of Medicine (ID-CRU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341727
- Sponsor's protocol ID
- 202003188
- Acronym
- WU352
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2020
- Last updated
- 25 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized Controlled Trial of Hydroxychloroquine, Hydroxychloroquine Plus Azithromycin, Chloroquine Alone, Chloroquine Plus Azithromycin in the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) Infection
- ClinicalTrials.gov ID
- NCT04341727
- Acronym / sponsor ID
- WU352 / 202003188
- Conditions
- Coronavirus Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB recommended study suspension slow accrual
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 4 Apr 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 10 Apr 2020 (actual)
- Results
- Posted 25 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring intensive care unit (ICU) admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.
Detailed description
This Phase III trial will utilize four treatment strategies in non-critically ill hospitalized participants (not requiring mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin. Investigators are primarily interested in the time to recovery. In addition to study medications there will be daily symptom surveys for 14 days, then weekly thereafter for 4 weeks resulting in a total duration of follow up of 42 days. During hospitalization, daily symptom surveys will be completed in conjunction with the study coordinators. On discharge participants will have the option to complete electronic symptom surveys or complete symptom surveys via telephone with study coordinator. In the event that the participant opts for electronic symptom surveys on discharge participants will in addition receive a follow up call from a study coordination every 7 days during the initial 14 day period. In addition, failure to submit a symptom survey will prompt a study follow up call. Data from standard of care SOC will be collected from medical records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine alone | Active comparator | Drug: Hydroxychloroquine SulfateArm 1: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets. |
| Hydroxychloroquine plus azithromycin | Active comparator | Drug: Hydroxychloroquine Sulfate, Drug: AzithromycinArm 2: Hydroxychloroquine 400mg orally twice a day for one day, followed by 200mg twice a day for four consecutive days (Five days in total). The drug will be supplied in 200mg tablets. AND Azithromycin 500mg orally once, followed by 250mg daily for four consecutive days (five days total). The drug will be supplied in 250mg tablets. |
| Chloroquine alone | Active comparator | Drug: Chloroquine SulfateArm 3: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets. |
| Chloroquine plus azithromycin | Active comparator | Drug: Azithromycin, Drug: Chloroquine SulfateArm 4: Chloroquine phosphate 1000mg orally once, followed in 12 hours by 500mg, then 500mg orally twice daily for 4 days (Five days in total). The drug will be supplied in 500mg tablets. AND Azithromycin 500mg orally once, followed by 250mg daily for 4 consecutive days (5 days total).The drug will be supplied in 250mg tablets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Hospitalization for management of SARS CoV-2 infection
- Positive SARS CoV-2 test
- Age >=18 years
- Provision of informed consent
- Electrocardiogram (ECG) ≤48 hours prior to enrollment
Key exclusion criteria (24 listed)
- Contraindication or allergy to chloroquine, hydroxychloroquine or azithromycin
- Current use hydroxychloroquine, chloroquine or azithromycin
- Concurrent use of another investigational agent
- Invasive mechanical ventilation
- Participants who have any severe and/or uncontrolled medical conditions such as:
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 SulfateAlso: HYDROXYCHLOROQUINE Plaquenilanti-rheumatic drug (DMARD) | Drug | Hydroxychloroquine alone, Hydroxychloroquine plus azithromycin |
| AzithromycinAlso: COMMON BRAND(S): Zithromax GENERIC NAME(S): AzithromycinAntibiotic | Drug | Chloroquine plus azithromycin, Hydroxychloroquine plus azithromycin |
| Chloroquine SulfateAlso: Aralen GENERIC NAME(S): Chloroquine PhosphateAntimalarial | Drug | Chloroquine alone, Chloroquine plus azithromycin |
Primary outcome
Hours to Recovery
Time frame: 42 days
Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death in each Arm/Group,respectively.
1 secondary outcome
Time to Fever Resolution
Time frame: 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jane O'Halloran, MD PhD principal investigator
Washington University School of Medicine (ID-CRU)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine Sulfate, Azithromycin and Chloroquine Sulfate in people with Coronavirus Infection, run by Washington University School of Medicine at 2 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 24 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 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 25 Apr 2024). 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?
Hours to Recovery (time frame: 42 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 25 Apr 2024.