Coronavirus InfectionPhase 1NCT04333654
Hydroxychloroquine in Outpatient Adults With COVID-19
A Phase 1 study testing Hydroxychloroquine SAR321068 in people with Coronavirus Infection, run by Sanofi at 7 sites in 4 countries.
Trial summary
Primary Objective: To assess the effect of hydroxychloroquine versus placebo on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19 Secondary Objectives: To assess the effect of hydroxychloroquine versus placebo on clinical signs and symptoms and progression of disease in outpatient adults with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- Hydroxychloroquine SAR321068
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 12 Apr 2020to 26 May 2020
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with diagnosis of COVID-19 via an approved or authorized molecular test
- Presence of symptoms compatible with COVID-19 at the time of screening
- Time between onset of symptoms and first dose of hydroxychloroquine or placebo is 96 hours or less
- Female participants must use an acceptable birth control method, as specified by each site and country
Who cannot join
- COVID-19 disease requiring the use of supplemental oxygen
- Electrocardiogram (ECG) tracing with QTc interval > 450 ms for men, > 470 ms for women (Fridericia algorithm recommended)
- Bradycardia (< 50 beats/min)
- History of cardiac disease (eg. congestive heart failure, myocardial infarction)
- History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Women who are pregnant or breastfeeding
Show all 14Show fewer
- Concurrent antimicrobial therapy
- Known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds
- Hydroxychloroquine use within 2 months before enrollment
- History of severe skin reactions such as Sevens-Johnson syndrome and toxic epidermal necrolysis
- History of retinopathy
- History of arrythmia, concurrent use of anti-arrhythmic drugs, or family history of sudden cardiac death
- History of severe renal disease (treatment with dialysis or phosphate binders) or hepatic impairment
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Belgium2 sites
Investigational Site Number 0561001
Brussels, BE-1200
Investigational Site Number 0561002
Lodelinsart, 6042
France2 sites
Investigational Site Number 2501001
Bordeaux, 33076
Investigational Site Number 2501002
Paris, 75005
Netherlands2 sites
Investigational Site Number 5281001
Groningen, 9728 NZ
Investigational Site Number 5281002
Harderwijk, 3844 DG
United States1 site
Investigational Site Number 8400001
Boston, Massachusetts, 02115
About this study
Official title: A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19
Primary Objective:
To assess the effect of hydroxychloroquine versus placebo on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19
Secondary Objectives:
- To assess the effect of hydroxychloroquine versus placebo on clinical signs and symptoms and progression of disease in outpatient adults with COVID-19
- To assess the safety and tolerability of hydroxychloroquine in outpatient adults with COVID-19
Read the detailed description
The duration of the study per participant will be around 18 days (1 or 2 days of screening followed by a 10-day treatment period and a 4 to 6 days follow-up period)
- Conditions
- Coronavirus Infection
- Being tested
- Hydroxychloroquine SAR321068, Placebo
- 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 SAR321068Drug
Also called Plaquenil
Pharmaceutical form:Tablet Route of administration: Oral
PlaceboDrug
Pharmaceutical form:Tablet Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | Hydroxychloroquine, loading dose on day 1 followed by a daily maintenance dose during 9 days Receives: Drug: Hydroxychloroquine SAR321068 |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Day 3 in nasopharyngeal SARS-CoV-2 viral load (if quantitative PCR is available)
Viral load assessed by PCR from a nasopharyngeal swab
Measured: Baseline to Day 3
Number of participants by PCR result status (positive or negative) (if quantitative PCR is not available)
Viral load assessed by PCR from a nasopharyngeal swab - 2. Viral load assessed by PCR from a nasopharyngeal swab
Measured: Baseline to Day 3
Secondary outcomes (8)
Change from baseline to Day 5 in nasopharyngeal SARS-CoV-2 viral load
Viral load assessed by PCR from a nasopharyngeal swab
Measured: Baseline to Day 5
Number of participants by PCR result status (positive or negative)
Viral load assessed by PCR from a nasopharyngeal swab
Measured: Baseline to end of study (Day14)
Number of participants with COVID-19 symptoms by severity
COVID-19 symptoms (feverishness, sore throat, cough, shortness of breath, myalgias) will be scored by the participant on a 4-point scale ( 0 =none; 1 = mild; 2 = moderate; 3 = severe)
Measured: Baseline to end of study (Day14)
Time to resolution of COVID-19 Symptoms
COVID-19 symptoms (feverishness, sore throat, cough, shortness of breath, myalgias) will be scored by the participant on a 4-point scale ( 0 =none; 1 = mild; 2 = moderate; 3 = severe). Resolution of a symptom is defined as when a symptom previously scored ≥ 1 on the scale is scored as 0
Measured: Baseline to end of study (Day14)
Time to resolution of fever
Resolution of fever defined as the first day of 2 consecutive daily temperatures < 37.7 C
Measured: Baseline to end of study (Day14)
Percentage of participants with resolution of fever
Resolution of fever defined as the first day of 2 consecutive daily temperatures < 37.7 C
Measured: Baseline to end of study (Day14)
Percentage of participants hospitalized
Measured: Baseline to end of study (Day14)
Number of participants with Adverse Events
Measured: Baseline to end of study (Day14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start12 Apr 2020
- Primary completion26 May 2020
- Study completion26 May 2020
Why it stopped: Rate of enrollment too slow to allow completion in a reasonable timeframe
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 SanofiThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333654
- Sponsor's protocol ID
- EFC16855
- Other IDs
- 2020-001269-35, U1111-1249-6168
- Status last verified
- Sep 2025
- First submitted
- 1 Apr 2020
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19
- ClinicalTrials.gov ID
- NCT04333654
- Acronym / sponsor ID
- EFC16855
- Conditions
- Coronavirus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Rate of enrollment too slow to allow completion in a reasonable timeframe
- Enrolment
- 8 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2020 (actual)
- Primary completion
- 26 May 2020 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 3 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.
Primary Objective:
To assess the effect of hydroxychloroquine versus placebo on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19
Secondary Objectives:
- To assess the effect of hydroxychloroquine versus placebo on clinical signs and symptoms and progression of disease in outpatient adults with COVID-19
- To assess the safety and tolerability of hydroxychloroquine in outpatient adults with COVID-19
Detailed description
The duration of the study per participant will be around 18 days (1 or 2 days of screening followed by a 10-day treatment period and a 4 to 6 days follow-up period)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: Hydroxychloroquine SAR321068Hydroxychloroquine, loading dose on day 1 followed by a daily maintenance dose during 9 days |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with diagnosis of COVID-19 via an approved or authorized molecular test
- Presence of symptoms compatible with COVID-19 at the time of screening
- Time between onset of symptoms and first dose of hydroxychloroquine or placebo is 96 hours or less
- Female participants must use an acceptable birth control method, as specified by each site and country
Key exclusion criteria (14 listed)
- COVID-19 disease requiring the use of supplemental oxygen
- Electrocardiogram (ECG) tracing with QTc interval > 450 ms for men, > 470 ms for women (Fridericia algorithm recommended)
- Bradycardia (< 50 beats/min)
- History of cardiac disease (eg. congestive heart failure, myocardial infarction)
- History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
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 SAR321068Also: PlaquenilPharmaceutical form:Tablet Route of administration: Oral | Drug | Hydroxychloroquine |
| PlaceboPharmaceutical form:Tablet Route of administration: Oral | Drug | Placebo |
Primary outcome
Change from baseline to Day 3 in nasopharyngeal SARS-CoV-2 viral load (if quantitative PCR is available)
Time frame: Baseline to Day 3
Viral load assessed by PCR from a nasopharyngeal swab
Number of participants by PCR result status (positive or negative) (if quantitative PCR is not available)
Time frame: Baseline to Day 3
Viral load assessed by PCR from a nasopharyngeal swab - 2. Viral load assessed by PCR from a nasopharyngeal swab
8 secondary outcomes
Change from baseline to Day 5 in nasopharyngeal SARS-CoV-2 viral load
Time frame: Baseline to Day 5
Number of participants by PCR result status (positive or negative)
Time frame: Baseline to end of study (Day14)
Number of participants with COVID-19 symptoms by severity
Time frame: Baseline to end of study (Day14)
Time to resolution of COVID-19 Symptoms
Time frame: Baseline to end of study (Day14)
Time to resolution of fever
Time frame: Baseline to end of study (Day14)
Percentage of participants with resolution of fever
Time frame: Baseline to end of study (Day14)
Percentage of participants hospitalized
Time frame: Baseline to end of study (Day14)
Number of participants with Adverse Events
Time frame: Baseline to end of study (Day14)
Results and safety
The study was stopped early (reason given: Rate of enrollment too slow to allow completion in a reasonable timeframe). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- EFC16855 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydroxychloroquine SAR321068 in people with Coronavirus Infection, run by Sanofi at 7 sites in 4 countries.
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 4 inclusion and 14 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 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, France, Netherlands, 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Rate of enrollment too slow to allow completion in a reasonable timeframe). 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?
Change from baseline to Day 3 in nasopharyngeal SARS-CoV-2 viral load (if quantitative PCR is available) (time frame: Baseline to Day 3). The study lists 2 primary outcomes in all. 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 23 Sep 2025.