Clinical Trial Results:
Treatment of Coronavirus SARS-Cov2 Respiratory Infections with Hydroxychloroquine
Summary
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EudraCT number |
2020-000890-25 |
Trial protocol |
FR |
Global end of trial date |
25 Mar 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Nov 2022
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First version publication date |
01 Nov 2022
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
202002102
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Fondation Méditerranée Infection
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Sponsor organisation address |
19-21 boulevard jean moulin, marseille, France, 13005
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Public contact |
IHU Méditerranée Infection, Fondation Méditerranée Infection (FMI) - IHU Méditerranée Infection, 0033 4 13 73 23 47, direction.ihu@mediterranee-infection.com
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Scientific contact |
IHU Méditerranée Infection, Fondation Méditerranée Infection (FMI) - IHU Méditerranée Infection, 0613637651 4 13 73 23 47, direction.ihu@mediterranee-infection.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
05 May 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
25 Mar 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
25 Mar 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To shorten the period of virus sheding and thus contagion
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Protection of trial subjects |
Monitoring will be as usual for short-term Plaquenil prescriptions, essentially three times a week monitoring of blood sugar and potassium levels. Drugs which may prolong the QT should only be prescribed if absolutely necessary.
In addition, serum hydroxychloroquine levels should be monitored twice a week in order to control residual levels and to adapt the dosage (target 1 to 2 µg/L).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
06 Mar 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 24
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Worldwide total number of subjects |
24
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EEA total number of subjects |
24
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
19
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From 65 to 84 years |
5
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients hospitalised in the APHM, for whom a diagnosis of SARS-CoV2 respiratory infection will be made on a pharyngeal swab or a deep respiratory sample by the IHU laboratory, will be contacted and offered to participate in the protocol, after having been expressly informed of the risks and expected benefits of Hydroxychloroquine treatment | ||||||||||||
Pre-assignment
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Screening details |
Patients with coronavirus disease COVID-19 Adults (18-64 years) Elderly (>= 65 years) | ||||||||||||
Period 1
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Period 1 title |
5th march 2020 (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||
Arms
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Arm title
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Experimental group | ||||||||||||
Arm description |
Patients treated by hydroxychloroquine | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Plaquenil 200 mg, comprimé pelliculé
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
600 mg per day
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Baseline characteristics reporting groups
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Reporting group title |
5th march 2020
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Experimental group
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Reporting group description |
Patients treated by hydroxychloroquine |
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End point title |
Results of SARS-COV2 virus detection at day 1 [1] | ||||||
End point description |
21 patients analysed for the primary endpoint "virus detection". These were the 21 patients who took the experimental treatment in accordance with the conditions set out in the clinical trial (dosage, duration, hospitalisation at the IHU, etc.).
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End point type |
Primary
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End point timeframe |
Day 1 after treatment
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: It is a descriptif study with 1 arm, there is no inference statistics results. |
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No statistical analyses for this end point |
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End point title |
Results of SARS-COV2 virus detection at day 4 [2] | ||||||
End point description |
21 patients analysed for the primary endpoint "virus detection". These were the 21 patients who took the experimental treatment in accordance with the conditions set out in the clinical trial (dosage, duration, hospitalisation at the IHU, etc.).
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End point type |
Primary
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End point timeframe |
Day 4 after treatment
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: It is a descriptif study with 1 arm, there is no inference statistics results. |
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No statistical analyses for this end point |
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End point title |
Results of SARS-COV2 virus detection at day 7 [3] | ||||||
End point description |
21 patients analysed for the primary endpoint "virus detection". These were the 21 patients who took the experimental treatment in accordance with the conditions set out in the clinical trial (dosage, duration, hospitalisation at the IHU, etc.).
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End point type |
Primary
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End point timeframe |
Day 7 after treatment
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: It is a descriptif study with 1 arm, there is no inference statistics results. |
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No statistical analyses for this end point |
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End point title |
Results of SARS-COV2 virus detection at day 14 [4] | ||||||
End point description |
21 patients analysed for the primary endpoint "virus detection". These were the 21 patients who took the experimental treatment in accordance with the conditions set out in the clinical trial (dosage, duration, hospitalisation at the IHU, etc.).
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End point type |
Primary
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End point timeframe |
Day 14 after treament
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Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: It is a descriptif study with 1 arm, there is no inference statistics results. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
- one nausea
- 2 patients were transferred to the intensive care unit on day 1 for complications of the disease (adaptation or discontinuation of the experimental treatment).
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Assessment type |
Systematic | ||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||
Dictionary version |
23
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Reporting groups
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Reporting group title |
Experimental group
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Reporting group description |
- | ||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |