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CoronavirusPhase 3HYCOVIDNCT04325893

Hydroxychloroquine Versus Placebo in COVID-19 Patients at Risk for Severe Disease

A Phase 3 study testing Hydroxychloroquine in people with Coronavirus, run by University Hospital, Angers at 47 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A new human coronavirus responsible for pneumonia, SARS-CoV-2, emerged in China in December 2019 and has spread rapidly. COVID-19, the disease caused by this virus, has a very polymorphous clinical presentation, which ranges from upper respiratory tract infections to acute respiratory distress syndrome. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus
What is being tested?
Hydroxychloroquine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
259 participants
Where
47 sitesin 2 countries
Study dates
1 Apr 2020to 18 Jun 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old
  • Symptomatic infection with COVID-19 confirmed by positive RT-PCR SARS-CoV-2 or, failing that, by thorax CT-scan suggesting viral pneumopathy of peripheral predominance in a clinically significant context.
  • Diagnosis in the previous two calendar days or, for an asymptomatic patient at the time of virological diagnosis, onset of symptoms in the previous two calendar days.
  • Patient having at least one of the following risk factors for developing complications:
  • Age ≥75 years old
  • Age between 60 and 74 years old and presence of at least one comorbidity among the following: obesity (body mass index ≥ 30 kg/m²), arterial hypertension requiring treatment, diabetes mellitus requiring treatment
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  • Need for supplemental oxygen to reach a peripheral capillary oxygen saturation of more than 94% (SpO2 > 94%), or a ratio of partial oxygen pressure to the fraction of inspired oxygen less than or equal to 300 mmHg (PaO2/FiO2 ≤ 300 mmHg).
  • Patient affiliated to a social security scheme.
  • Written and signed consent of the patient or a relative or emergency inclusion procedure.

Who cannot join

  • Last RT-PCR negative for SARS-CoV-2
  • Peripheral capillary oxygen saturation less than or equal to 94% (SpO2 ≤ 94%) despite oxygen therapy greater than or equal to 3 L/min (> 3 L/min)
  • Organ failure requiring admission to a critical or intensive care unit.
  • Comorbidity that is life threatening in the short-term (life expectancy < 3 months)
  • Any reason that makes patient follow-up throughout the study impossible
  • Current treatment with hydroxychloroquine
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  • Absolute contraindication to treatment with hydroxychloroquine (known hypersensitivity, retinopathy, concomitant treatment with risk of ventricular disorders, particularly torsades de pointe, known deficit of glucose-6-phosphate dehydrogenase, porphyria)
  • Hypokalaemia < 3.5 mmol/L
  • Corrected QT prolongation (QTc ≥ 440 ms in men and 460 ms in women).
  • Child-Pugh's class C liver cirrhosis
  • Chronic kidney failure with estimated GFR ≤ 30 ml/min, or ≤ 40 ml/min in patients with concomitant treatment with azithromycin
  • Women who are pregnant, breastfeeding, or parturient

Trial locations and contacts

47 sites in 2 countries.

47 sites in 2 countries

France46 sites

  • CH Agen

    Agen

  • CHU Amiens

    Amiens

  • CHU Angers

    Angers

  • CH Auxerre

    Auxerre

  • APHP Avicenne

    Bobigny

  • CHU Brest

    Brest

  • CHU Caen

    Caen

  • CH Chalon Sur Saône

    Chalon-sur-Saône

  • CH Cherbroug

    Cherbourg

  • CH Cholet

    Cholet

  • CH Colmar

    Colmar

  • CH Compiègne

    Compiègne

  • APHP Henri Mondor

    Créteil

  • CH Intercommunal Créteil

    Créteil

  • CHU Dijon

    Dijon

  • APHP Joffre Dupuytren

    Draveil

  • CHD Vendée

    La Roche-sur-Yon

  • CH Laval

    Laval

  • CH Le Mans

    Le Mans

  • CH Emile Roux

    Le Puy-en-Velay

  • APHP Emile ROUX

    Limeil-Brévannes

  • CHU Limoges

    Limoges

  • CH Lorient

    Lorient

  • Hôpital Européen - Marseille

    Marseille

  • Hôpital Saint-Joseph

    Marseille

  • CH Melun

    Melun

  • CHU Nantes

    Nantes

  • Hôpital Privé du Confluent

    Nantes

  • CH Niort

    Niort

  • CHR Orléans

    Orléans

  • APHP Saint-Antoine

    Paris

  • GH Croix Saint Simon

    Paris

  • La Pitié-Salpétrière

    Paris

  • CHU Poitiers

    Poitiers

  • CH Pointoise

    Pontoise

  • CH Quimper

    Quimper

  • CH Saint-Brieuc

    Saint-Brieuc

  • CHU Saint-Etienne

    Saint-Etienne

  • CH Saint-Nazaire

    Saint-Nazaire

  • CHU Toulouse

    Toulouse

  • CH Tourcoing

    Tourcoing

  • CHU Tours

    Tours

  • CH Valenciennes

    Valenciennes

  • Clinique Tessier Valenciennes

    Valenciennes

  • CH Vannes

    Vannes

  • CH Versailles

    Versailles

Other trials in France

Monaco1 site

  • CH Princesse Grace

    Monaco

Other trials in Monaco

About this study

Official title: Hydroxychloroquine Versus Placebo in Patients Presenting COVID-19 Infection and at Risk of Secondary Complication: a Prospective, Multicentre, Randomised, Double-blind Study

A new human coronavirus responsible for pneumonia, SARS-CoV-2, emerged in China in December 2019 and has spread rapidly. COVID-19, the disease caused by this virus, has a very polymorphous clinical presentation, which ranges from upper respiratory tract infections to acute respiratory distress syndrome. It may appear serious straightaway or may evolve in two stages, with a worsening 7 to 10 days after the first clinical signs, potentially linked to a cytokine storm and accompanied by a high risk of thrombosis. The global mortality rate of COVID-19 is between 3% and 4%, with severe forms being more frequent among older patients. Management is symptomatic as no antiviral treatment has demonstrated any clinical benefit in this condition. Hydroxychloroquine is a derivative of chloroquine commonly used in some autoimmune diseases, such as systemic lupus erythematosus. It is active in vitro in cellular models of infection by many viruses such as HIV, hepatitis C or SARS-CoV. However, its interest in viral infections in humans has not been demonstrated.

Very recently, a preliminary uncontrolled study evaluated the effect of hydroxychloroquine on viral shedding in subjects with COVID-19. Among 20 patients treated with hydroxychloroquine at a dose of 600 mg per day, the percentage of patients with detectable SARS-CoV-2 RNA in the nasopharynx decreased from 100% at inclusion (start of treatment) to 43% six days later. In comparison, 15 of 16 untreated patients had a positive RT-PCR six days after inclusion. Furthermore, hydroxychloroquine has immunomodulating and anti-inflammatory properties, which could theoretically prevent or limit secondary worsening.

The research hypothesis is that treatment with hydroxychloroquine improves prognosis and reduces the risk of death or use for invasive ventilation in patients with COVID-19.

Conditions
Coronavirus
Being tested
Hydroxychloroquine, 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.

  • HydroxychloroquineDrug

    First dose of 400 mg will be taken immediately after inclusion at day 0, the second dose of 400 mg will be taken on the same evening and at least 4 hours after the first dose. The treatment will then be continued for the following eight days at a rate of 200 mg in the morning and evening.

  • PlaceboDrug

    TFirst dose of 400 mg will be taken immediately after inclusion at day 0, the second dose of 400 mg will be taken on the same evening and at least 4 hours after the first dose. The treatment will then be continued for the following eight days at a rate of 200 mg in the morning and evening.

Study groups in NCT04325893
Study groupRoleWhat they receive
HydroxychloroquineActive comparatorNot described
Receives: Drug: Hydroxychloroquine
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of death from any cause, or the need for intubation and mechanical ventilation during the 14 days following inclusion and start of treatment.

    Measured: Day 14

Secondary outcomes (12)

  1. Number of death from any cause, or the need for intubation and mechanical ventilation during the 28 days following inclusion and start of treatment.

    Measured: Day 28

  2. Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 14

    WHO Ordinal Scale for Clinical Improvement ranges from 0 to 8, higher score meaning poorer outcome

    Measured: Day 14

  3. Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 28.

    WHO Ordinal Scale for Clinical Improvement ranges from 0 to 8, higher score meaning poorer outcome

    Measured: Day 28

  4. Number of all-cause mortality at day 14

    Measured: Day 14

  5. Number of all-cause mortality at day 28

    Measured: Day 28

  6. Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples at day 5

    Measured: Day 5

  7. Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples at day 10

    Measured: Day 10

  8. The rate of venous thromboembolic events at day 28, documented and confirmed by an adjudication committee.

    Measured: Day 28

  9. Number of all-cause mortality at day 28 in patients aged 75 and older

    Measured: day 28

  10. Clinical evolution on the WHO OSCI scale for COVID-19 between day 0 and day 28 for patients aged 75 or older

    Measured: day 28

  11. Rate of severe adverse events at day 28

    Measured: day 28

  12. Number of all-cause mortality at day 14 in patients aged 75 and older

    Measured: day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2020
  2. Study start1 Apr 2020
  3. Primary completion18 Jun 2020
  4. Study completion18 Jun 2020

Why it stopped: decrease in number of eligible patients

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
259 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04325893
Sponsor's protocol ID
49RC20_0071
Acronym
HYCOVID
Status last verified
Apr 2020
First submitted
25 Mar 2020
Last updated
6 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dubee V, Roy PM, Vielle B, Parot-Schinkel E, Blanchet O, Darsonval A, Lefeuvre C, Abbara C, Boucher S, Devaud E, Robineau O, Rispal P, Guimard T, d'Anglejean E, Diamantis S, Custaud MA, Pellier I, Mercat A; HYCOVID study group; HYCOVID investigators; Angers University Hospital; Cholet Hospital; Laval Hospital; Le Mans Hospital; Tours University Hospital; Quimper Hospital; La Roche sur Yon Hospital; Tourcoing Hospital; Orleans Hospital; Nantes University Hospital; Niort Hospital; Lorient Hospital; Brest University Hospital; Cherbourg Hospital; Saint-Brieuc Hospital; Creteil - APHP University Hospital; Saint-Antoine - APHP University Hospital; Saint-Etienne University Hospital; Toulouse University Hospital; Melun Hospital; Dijon University Hospital; Princesse Grace - Monaco Hospital; Versailles Hospital; Colmar Hospital; Agen-Nerac Hospital; Caen University Hospital; Saint-Nazaire Hospital; Nantes - Confluent Hospital; Limoges University Hospital; Poitiers University Hospital; Amiens University Hospital; Bobigny - APHP University Hospital; Cergy-Pontoise Hospital; Valencienne Hospital; Valencienne - Clinique Tessier Hospital; Henri-Mondor - APHP University Hospital; Chalon-sur-Saone Hospital; Marseille European Hospital; Auxerre Hospital; Diaconnesses Croix-Saint-Simon Hospital; Marseille - Saint Joseph Hospital; HYCOVID management team: Steering committee (authors); HYCOVID management team: Independant data safety and monitoring board; HYCOVID management team: Independent adjudication of clinical events committee; Study management: Coordination; Study management: Data management. Hydroxychloroquine in mild-to-moderate coronavirus disease 2019: a placebo-controlled double blind trial. Clin Microbiol Infect. 2021 Aug;27(8):1124-1130. doi: 10.1016/j.cmi.2021.03.005. Epub 2021 Apr 1.

    PubMed 33813110

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hydroxychloroquine in people with Coronavirus, run by University Hospital, Angers at 47 sites in 2 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 9 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 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in France, Monaco. 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 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: decrease in number of eligible patients). 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?

Number of death from any cause, or the need for intubation and mechanical ventilation during the 14 days following inclusion and start of treatment. (time frame: Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04325893, which also lists 1 linked publication.

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 6 Oct 2020.

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