ClinicalTrials.gov

History of Changes for Study: NCT04325893
Hydroxychloroquine Versus Placebo in Patients Presenting COVID-19 Infection and at Risk of Secondary Complication: a Prospective, Multicentre, Randomised, Double-blind Study (HYCOVID)
Latest version (submitted October 2, 2020) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 March 27, 2020 None (earliest Version on record)
2 April 2, 2020 Outcome Measures, Study Status, Contacts/Locations, Eligibility, Study Description, Oversight and Study Identification
3 April 7, 2020 Recruitment Status, Contacts/Locations, Outcome Measures and Study Status
4 May 15, 2020 Study Status, Contacts/Locations, Eligibility and Arms and Interventions
5 October 2, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT04325893
Submitted Date:  March 27, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 49RC20_0071
Brief Title: Hydroxychloroquine Versus Placebo in Patients Presenting COVID-19 Infection and at Risk of Secondary Complication: a Prospective, Multicentre, Randomised, Double-blind Study (HYCOVID)
Official Title: Hydroxychloroquine Versus Placebo in Patients Presenting COVID-19 Infection and at Risk of Secondary Complication: a Prospective, Multicentre, Randomised, Double-blind Study
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2020
Overall Status: Not yet recruiting
Study Start: April 2020
Primary Completion: September 2020 [Anticipated]
Study Completion: September 2020 [Anticipated]
First Submitted: March 25, 2020
First Submitted that
Met QC Criteria:
March 27, 2020
First Posted: March 30, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
March 27, 2020
Last Update Posted: March 30, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University Hospital, Angers
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary:

A new human coronavirus that is transmitted through respiratory droplets, 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 isolated attacks on the upper respiratory tract to acute respiratory distress syndrome. It may appear serious straightaway or may develop in two stages, with a worsening condition 7 to 10 days after the initial clinical signs, potentially linked to a cytokine storm in the immune system and accompanied by a high risk of thrombosis. The global mortality rate of COVID-19 is understood to be between 3% and 4%, with the more severe forms being more frequent among older age groups. Treatment is largely symptomatic as no antiviral treatment to date has shown to be of clinical benefit to this illness. Hydroxychloroquine is a derivative of chloroquine, which is commonly used to treat some autoimmune diseases, such as systemic lupus erythematosus. It is active in vitro in cell models of infection by multiple viruses, such as HIV, hepatitis C and SARS-CoV. However, its use in viral infections among humans has not been demonstrated.

Very recently, a non-controlled preliminary study looked into the effectiveness of hydroxychloroquine on the viral excretion of subjects affected by COVID-19. Among 20 patients treated with hydroxychloroquine in doses of 600 mg per day, the percentage of viral findings of positive SARS-CoV-2 in the nasopharynx using RT-PCR went from 100% on inclusion (start of treatment) to 43% six days later. In comparison, among the 16 patients who were not treated, 90% had a positive RT-PCR six days after inclusion. Furthermore, hydroxychloroquine has immunomodulating and anti-inflammatory properties, which could theoretically prevent or limit secondary complications.

The research hypothesis is that treatment with hydroxychloroquine improves prognosis and reduces the risk of death or using an invasive artificial ventilator on patients suffering from COVID-19.

Detailed Description:
Open or close this module Conditions
Conditions: Coronavirus
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 1300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Hydroxychloroquine Drug: Hydroxychloroquine
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 the treatment will then be continued for the following eight days at a rate of 200 mg in the morning and evening.
Placebo Comparator: Placebo Drug: Placebo
The 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 the treatment will then be continued for the following eight days at a rate of 200 mg in the morning and evening.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Death, regardless of cause, or the use of intubation and invasive ventilation in the 14 days (day 14) following inclusion and the start of treatment (day 0)
[ Time Frame: Day 14 ]

Secondary Outcome Measures:
1. Death, regardless of cause, or the use of intubation and invasive ventilation at day 28.
[ Time Frame: Day 28 ]

2. Clinical development on the OSCI scale for COVID-19 by the WHO between day 0-day 14
[ Time Frame: Day 14 ]

3. Clinical development on the OSCI scale for COVID-19 by the WHO between day 0-day 28
[ Time Frame: Day 28 ]

4. All-cause mortality at day 14
[ Time Frame: Day 14 ]

5. All-cause mortality at day 28
[ Time Frame: Day 28 ]

6. Rate of RT-PCR positive for SARS-CoV-2 with nasopharynx samples at day 5
[ Time Frame: Day 5 ]

7. Rate of RT-PCR positive for SARS-CoV-2 with nasopharynx samples at day 10
[ Time Frame: Day 10 ]

8. Rate of thrombo-phlebitis or symptomatic arterial occurrences at day 28
[ Time Frame: Day 28 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Adult patient
  • Infection with COVID-19 confirmed by RT-PCR SARS-CoV-2 or, failing that, by thoracic scans suggesting viral pneumonia of peripheral predominance in a clinically significant context.
  • Diagnosed within the previous 48 hours.
  • Having at least one of the following two risk factors for complications:
  • age ≥75 years old
  • oxygen dependant with peripheral capillary oxygen saturation (SpO2) ≤ 94% in ambient air, or a partial oxygen pressure ratio (PaO2) to oxygen fraction of inspired air (FiO2) ≤ 300 mmHg.

Patients affiliated with or benefitting from a social security scheme

- Written and signed consent of the patient or a relative or, if not possible, emergency inclusion procedure

Exclusion Criteria:

  • RT-PCR SARS-CoV-2 negative
  • 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 resuscitation or high dependency unit
  • Comorbidity that is life-threatening in the short-term (life expectancy <3 months)
  • Any reason that makes follow-up at day 28 impossible
  • Current treatment with hydroxychloroquine
  • Absolute contraindication to treatment with hydroxychloroquine (known hypersensitivity, concomitant treatment with risk of torsades de pointe)
  • ECG in at-risk patients showing corrected QT prolongation greater than 440 ms in men and 460 ms in women.
  • Pregnant, lactating or parturient women
  • Individuals in detention through judicial or administrative decision
  • Individuals who are the subject of compulsory psychiatric treatment
  • Individuals who are subject to legal protection measures
Open or close this module Contacts/Locations
Central Contact Person: Vincent DUBEE
Telephone: 241353872 Ext. +33
Email: vincent.dubee@chu-angers.fr
Central Contact Backup: BĂ©atrice GABLE
Telephone: 241356825 Ext. +33
Email: begable@chu-angers.fr
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services