Coronavirus InfectionPhase 2/3COVIDOCNCT04345861
Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for COVID-19 Pneumonia (COVIDOC Trial)
A Phase 2/3 study testing hydroxychloroquine + azithromycin in people with Coronavirus Infection and Pneumonia, Viral, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Double blinded randomized clinical trial designed to evaluate the efficacy and safety of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with confirmed COVID-19 pneumonia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronavirus Infection, Pneumonia, Viral
- What is being tested?
- hydroxychloroquine + azithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2020to 9 Apr 2021
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old SARS CoV-2 Infection confirmed by positive virologic test realised in the 96 h before randomization
- Beginning of COVID-19 symptoms < 10 days at the time of randomization
- Presence of symptom(s) of COVID-19 : fever (température > or = 37,5°C) or respiratory sign(s) (cough, breathing discomfort) or recent anosmia
- Presence of TDM/radiographic signs or pneumonia
- Hospitalization out of ICU for COVID with: moderate clinical form (no oxygenotherapy) or non critical severe form (oxygenotherapy)
Who cannot join
- Absence of signed informed consent
- SpO2 < 90 % ambient air or < 94 % with oxygenotherapy > or = 3l/min
- Need of oxygenotherapy > 6 l/min or mechanical ventilation
- Need of hospitalization in ICU
- ALAT/ASAT > 5 LSN
- Renal failure (eGFR < 40 ml/min ) or dialysis
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- Pregnancy or breastfeeding
- Retinopathy
- Known deficit in G6PD
- Cardiac rythm / lengthening QT disorders
- QT space lengthening on ECG with QTc > 450 ms
- Concomitant treatment :citalopram, escitalopram, hydroxyzine, domperidone, pipéraquine, anti-arhythmic class IA \& III, antidepressive drugs,..
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Assessing Efficacy and Safety of Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for Hospitalized Adults With COVID-19 Pneumonia
Double blinded randomized clinical trial designed to evaluate the efficacy and safety of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with confirmed COVID-19 pneumonia.
Read the detailed description
The multi-centre COVIDOC study will evaluate the efficacy and safety of the use of hydroxychloroquine (10 days) combined with azithromycin (5 days) compared to hydroxychloroquine (10 days) in the the clinical evolution by the ordinal scale of 7 points in adults hospitalized outside Intensive care unit with pneumonia caused by infection by the SARS-CoV2 virus in France.
- Conditions
- Coronavirus Infection, Pneumonia, Viral
- Being tested
- Hydroxychloroquine + placebo, hydroxychloroquine + azithromycin
- Keywords
- SARS-CoV2 virus, COVID-19, pneumonia, hydroxychloroquine, azithromycin
- Medical subject headings
- Coronavirus Infections, Pneumonia, Viral, COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine + placeboDrug
hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11)
hydroxychloroquine + azithromycinDrug
Combination hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11) Azithromycin 500mg (day 1) then 250 mg (Day 2 to Day 5)
| Study group | Role | What they receive |
|---|---|---|
| monotherapy hydroxychloroquine | Active comparator | Hydroxychloroquine 800mg (Day 1), 600mg (from Day 2 to Day 10) + placebo from Day 1 to Day 5 Receives: Drug: Hydroxychloroquine + placebo |
| combination hydroxychloroquine + azithromycin | Experimental | Hydroxychloroquine 800mg (Day 1), 600mg (from Day 2 to Day 10) and azithromycin 500mg (Day 1 ), 250 mg (from day 2 to Day 5) Receives: Drug: hydroxychloroquine + azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical improvement of at least 1 level on the ordinal scale between Day 1 (day of the first administration of study drug) to Day 11 (day after last day of treatment).
Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points (score range from 1 to 7 , with 7 being the worst score)
Measured: up to Day 11
Secondary outcomes (8)
Clinical status assessed by ordinal scale
Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points at day 15 and day 29
Measured: up to Day 29
transfer to ICU
Necessity for transfer to Intensive care unit
Measured: up to Day 29
Length of hospital day
days from admission to hospital discharge
Measured: up to Day 29
Hospital Mortality
incidence of all-cause mortality
Measured: Day 29
Need to Mechanical Ventilation
Need to mechanical ventilation
Measured: up to Day 29
Occurence of grade 3-4 adverse event
adverse reactions
Measured: up to Day 29
QTc Lengthening
ECG
Measured: up to Day 11
Evolution of pulmonary CT scan images
Thoracic CT scan : number and size of ground-glass opacifications on day 1 and day 11 Two independent pulmonary imagery experts will assess abnormalities according to a standardized framework
Measured: up to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start11 Apr 2020
- Primary completion9 Feb 2021
- Study completion9 Apr 2021
Why it stopped: halted prematurely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques REYNES, MD,PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345861
- Sponsor's protocol ID
- RECHMPL20_168
- Acronym
- COVIDOC
- Status last verified
- Dec 2021
- First submitted
- 5 Apr 2020
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Assessing Efficacy and Safety of Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for Hospitalized Adults With COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04345861
- Acronym / sponsor ID
- COVIDOC / RECHMPL20_168
- Conditions
- Coronavirus Infection, Pneumonia, Viral
- Keywords
- SARS-CoV2 virus, COVID-19, pneumonia, hydroxychloroquine, azithromycin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: halted prematurely.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 11 Apr 2020 (actual)
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 15 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.
Double blinded randomized clinical trial designed to evaluate the efficacy and safety of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with confirmed COVID-19 pneumonia.
Detailed description
The multi-centre COVIDOC study will evaluate the efficacy and safety of the use of hydroxychloroquine (10 days) combined with azithromycin (5 days) compared to hydroxychloroquine (10 days) in the the clinical evolution by the ordinal scale of 7 points in adults hospitalized outside Intensive care unit with pneumonia caused by infection by the SARS-CoV2 virus in France.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monotherapy hydroxychloroquine | Active comparator | Drug: Hydroxychloroquine + placeboHydroxychloroquine 800mg (Day 1), 600mg (from Day 2 to Day 10) + placebo from Day 1 to Day 5 |
| combination hydroxychloroquine + azithromycin | Experimental | Drug: hydroxychloroquine + azithromycinHydroxychloroquine 800mg (Day 1), 600mg (from Day 2 to Day 10) and azithromycin 500mg (Day 1 ), 250 mg (from day 2 to Day 5) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-75 years old SARS CoV-2 Infection confirmed by positive virologic test realised in the 96 h before randomization
- Beginning of COVID-19 symptoms < 10 days at the time of randomization
- Presence of symptom(s) of COVID-19 : fever (température > or = 37,5°C) or respiratory sign(s) (cough, breathing discomfort) or recent anosmia
- Presence of TDM/radiographic signs or pneumonia
- Hospitalization out of ICU for COVID with: moderate clinical form (no oxygenotherapy) or non critical severe form (oxygenotherapy)
Key exclusion criteria (12 listed)
- Absence of signed informed consent
- SpO2 < 90 % ambient air or < 94 % with oxygenotherapy > or = 3l/min
- Need of oxygenotherapy > 6 l/min or mechanical ventilation
- Need of hospitalization in ICU
- ALAT/ASAT > 5 LSN
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 + placebohydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11) | Drug | monotherapy hydroxychloroquine |
| hydroxychloroquine + azithromycinCombination hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11) Azithromycin 500mg (day 1) then 250 mg (Day 2 to Day 5) | Drug | combination hydroxychloroquine + azithromycin |
Primary outcome
Time to clinical improvement of at least 1 level on the ordinal scale between Day 1 (day of the first administration of study drug) to Day 11 (day after last day of treatment).
Time frame: up to Day 11
Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points (score range from 1 to 7 , with 7 being the worst score)
8 secondary outcomes
Clinical status assessed by ordinal scale
Time frame: up to Day 29
transfer to ICU
Time frame: up to Day 29
Length of hospital day
Time frame: up to Day 29
Hospital Mortality
Time frame: Day 29
Need to Mechanical Ventilation
Time frame: up to Day 29
Occurence of grade 3-4 adverse event
Time frame: up to Day 29
QTc Lengthening
Time frame: up to Day 11
Evolution of pulmonary CT scan images
Time frame: up to Day 11
Results and safety
The study was stopped early (reason given: halted prematurely.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- 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.
Jacques REYNES, MD,PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing hydroxychloroquine + azithromycin in people with Coronavirus Infection and Pneumonia, Viral, run by University Hospital, Montpellier at 1 site in France.
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 12 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 15 Dec 2021. 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 France. 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 combined 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.
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: halted prematurely.). 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?
Time to clinical improvement of at least 1 level on the ordinal scale between Day 1 (day of the first administration of study drug) to Day 11 (day after last day of treatment). (time frame: up to Day 11). 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 15 Dec 2021.