A Study to Compare the Efficacy of GNS561 Versus Standard of Care in Patients With SARS-CoV-2 (COVID-19) Infection (CureCovid-2019)
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|ClinicalTrials.gov Identifier: NCT04637828|
Recruitment Status : Unknown
Verified November 2020 by Genoscience Pharma.
Recruitment status was: Recruiting
First Posted : November 20, 2020
Last Update Posted : July 28, 2021
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: GNS561||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||178 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||open-label, controlled, randomized phase 2 study|
|Masking:||None (Open Label)|
|Official Title:||Cure COVID: A Prospective, Controlled, Randomized Study to Compare the Efficacy of GNS561 Versus Standard of Care in Patients With SARS-CoV-2 (COVID-19) Infection|
|Actual Study Start Date :||November 18, 2020|
|Estimated Primary Completion Date :||July 30, 2021|
|Estimated Study Completion Date :||December 30, 2021|
Experimental: GNS561 plus standard of care
All patients in this Arm will be treated with 200mg oral capsule of GNS561, once a day, for 10 days and with any necessary measures based on the patient's condition and at the investigator's discretion and routine practices.
No Intervention: standard of care
All patients in this Arm will be treated with any necessary measures based on the patient's condition and at the investigator's discretion and routine practices.
- number and proportion of participants, per randomized group, with a loss of one or two grades of National Early Warning Score (NEWS2) score at day-7 compared to baseline [ Time Frame: 7 days ]severe stage at baseline to medium or low stage at day-7 or medium stage at baseline to low stage at day-7
- the 28-day survival rate [ Time Frame: 28 days ]the crude proportion of patients still alive 28 days after randomization
- the rate of intensive care unit admission [ Time Frame: 14 days ]to 14 days from randomization
- the rate of nasopharyngeal swab negativation at D7, D14 and D28 [ Time Frame: 7 days, 14 days and 28 days ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||age 18 or older at the time of enrolment for women and age 60 or older at the time of enrolment for men.|
|Accepts Healthy Volunteers:||No|
- Documented diagnosis of COVID-19 (diagnostic test performed in a certified laboratory).
- Clinical status: Hospitalized for moderate COVID-19 with News2 score between 5 and 6
- Patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (quinine, tafenoquine, hydroxychloroquine, mefloquine).
- History of QT prolongation (QTc ≥ 500 ms) or QTc ≥ 500msec at screening or bradycardia < 50/mn
- Current use of loop diuretics and potassium supplementation or documented history of hypokalemia or hypokalemia < 3.5mmol/l at screening
- Prior allogeneic bone marrow transplantation or solid organ transplant in the past.
- Pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04637828
|Marseille, France, 13006|
|Contact: Christelle Ansaldi, MD +33(4) 91 26 99 50 email@example.com|
|Responsible Party:||Genoscience Pharma|
|Other Study ID Numbers:||
|First Posted:||November 20, 2020 Key Record Dates|
|Last Update Posted:||July 28, 2021|
|Last Verified:||November 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases