COVID-19Phase 3RCTNCT04344444
Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease
A Phase 3 study testing Hydroxychloroquine and Azithromycin in people with COVID-19, run by LCMC Health at 1 site in United States.
Trial summary
This study proposes to evaluate clinical outcomes and viral load in COVID-19 infected patients with early moderate and severe disease admitted to the hospital and randomized to one of three arms. Patients will be randomized to supportive care, OR hydroxychloroquine alone, OR hydroxychloroquine and azithromycin. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Hydroxychloroquine and Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2020to 5 Jan 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Positive SARS-CoV-2 testing or consistent clinical syndrome (based on clinical picture e.g. characteristic infiltrates on chest x-ray, laboratory findings, and with agreement by two physicians) in patients under investigation (PUIs).
- Onset of symptoms < 7 days from date of enrollment
- Oxygen saturation of >94% on room air with defined risk factors (Table 1) consistent with moderate disease OR oxygen saturation of < 94% on room air consistent with severe disease
- Ability and willingness to comply with study procedures
Who cannot join
- QTc greater than 450 milliseconds on screening EKG
- Pregnant or lactating women
- Inability to take oral pills or inability to use a feeding tube
- Inability to obtain informed consent either from the patient or from the next of kin if patient is incapacitated. For the purpose of this study obtaining a verbal consent from a family member on the phone with a witness will be considered acceptable since there is a 'no visitor' policy in force at hospitals.
- Patients requiring ICU level care
- use of azithromycin or hydroxychloroquine within 30 days prior to admission
Trial locations and contacts
1 site in 1 country.
United States1 site
University Medical Center New Orleans
New Orleans, Louisiana, 70112
About this study
Official title: Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease: A Randomized Clinical Trial
This study proposes to evaluate clinical outcomes and viral load in COVID-19 infected patients with early moderate and severe disease admitted to the hospital and randomized to one of three arms. Patients will be randomized to supportive care, OR hydroxychloroquine alone, OR hydroxychloroquine and azithromycin.
Read the detailed description
This is a phase 3 study.
Primary Objective:
- To evaluate clinical outcomes in patients with suspected or confirmed COVID-19 with early moderate to severe disease in a randomized controlled trial.
Secondary Objectives:
- To evaluate quantitative viral load over time
- To evaluate length of hospital stay and days in ICU
- To evaluate toxicity of the treatment options
- To evaluate rate of readmission after hospital discharge
- To evaluate duration of clinical symptoms
Arm A:
Control Arm - Supportive Care Only
Arm B:
Hydroxychloroquine 400 mg po bid on Day 1 Hydroxychloroquine 200 mg po bid Days 2 through 5
Arm C:
Hydroxychloroquine as in Arm B AND Azithromycin 500 mg po on Day 1 Azithromycin 250 mg po days 2 through 5
- 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.
tablets provided as described in Arm B
AzithromycinDrug
tablets provided as described in Arm C
| Study group | Role | What they receive |
|---|---|---|
| Arm A | No intervention | Supportive Care only |
| Arm B | Experimental | Hydroxychloroquine 400 mg po bid on Day 1 Hydroxychloroquine 200 mg po bid Days 2 through 5 Receives: Drug: Hydroxychloroquine |
| Arm C | Experimental | Hydroxychloroquine as in Arm B AND Azithromycin 500 mg po on Day 1 Azithromycin 250 mg po days 2 through 5 Receives: Drug: Hydroxychloroquine; Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Most severe outcome
ordinal outcome of most severe a patient experienced after inpatient admission
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start13 Apr 2020
- Primary completion10 Apr 2021
- Study completion5 Jan 2022
Why it stopped: Lack of efficacy data from other studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- LCMC Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meredith Clement, MD, Principal investigator, LSUHSC/UMCNO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344444
- Sponsor's protocol ID
- COVID 2020-001
- Acronym
- RCT
- Status last verified
- Aug 2020
- First submitted
- 10 Apr 2020
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04344444
- Acronym / sponsor ID
- RCT / COVID 2020-001
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy data from other studies
- Enrolment
- 22 participants (actual)
- Lead sponsor
- LCMC HealthUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes to evaluate clinical outcomes and viral load in COVID-19 infected patients with early moderate and severe disease admitted to the hospital and randomized to one of three arms. Patients will be randomized to supportive care, OR hydroxychloroquine alone, OR hydroxychloroquine and azithromycin.
Detailed description
This is a phase 3 study.
Primary Objective:
- To evaluate clinical outcomes in patients with suspected or confirmed COVID-19 with early moderate to severe disease in a randomized controlled trial.
Secondary Objectives:
- To evaluate quantitative viral load over time
- To evaluate length of hospital stay and days in ICU
- To evaluate toxicity of the treatment options
- To evaluate rate of readmission after hospital discharge
- To evaluate duration of clinical symptoms
Arm A:
Control Arm - Supportive Care Only
Arm B:
Hydroxychloroquine 400 mg po bid on Day 1 Hydroxychloroquine 200 mg po bid Days 2 through 5
Arm C:
Hydroxychloroquine as in Arm B AND Azithromycin 500 mg po on Day 1 Azithromycin 250 mg po days 2 through 5
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | No intervention | –Supportive Care only |
| Arm B | Experimental | Drug: HydroxychloroquineHydroxychloroquine 400 mg po bid on Day 1 Hydroxychloroquine 200 mg po bid Days 2 through 5 |
| Arm C | Experimental | Drug: Hydroxychloroquine, Drug: AzithromycinHydroxychloroquine as in Arm B AND Azithromycin 500 mg po on Day 1 Azithromycin 250 mg po days 2 through 5 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than 18 years
- Positive SARS-CoV-2 testing or consistent clinical syndrome (based on clinical picture e.g. characteristic infiltrates on chest x-ray, laboratory findings, and with agreement by two physicians) in patients under investigation (PUIs).
- Onset of symptoms < 7 days from date of enrollment
- Oxygen saturation of >94% on room air with defined risk factors (Table 1) consistent with moderate disease OR oxygen saturation of < 94% on room air consistent with severe disease
- Ability and willingness to comply with study procedures
Key exclusion criteria (6 listed)
- QTc greater than 450 milliseconds on screening EKG
- Pregnant or lactating women
- Inability to take oral pills or inability to use a feeding tube
- Inability to obtain informed consent either from the patient or from the next of kin if patient is incapacitated. For the purpose of this study obtaining a verbal consent from a family member on the phone with a witness will be considered acceptable since there is a 'no visitor' policy in force at hospitals.
- Patients requiring ICU level care
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 |
|---|---|---|
| Hydroxychloroquinetablets provided as described in Arm B | Drug | Arm B, Arm C |
| Azithromycintablets provided as described in Arm C | Drug | Arm C |
Primary outcome
Most severe outcome
Time frame: 5 days
ordinal outcome of most severe a patient experienced after inpatient admission
Results and safety
The study was stopped early (reason given: Lack of efficacy data from other studies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Meredith Clement, MD principal investigator
LSUHSC/UMCNO
1 site 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 and Azithromycin in people with COVID-19, run by LCMC Health 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 6 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 21 Jan 2022. 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 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?
The study was stopped early (reason given: Lack of efficacy data from other studies). Results are not available in the source record.
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?
Most severe outcome (time frame: 5 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 21 Jan 2022.