COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04637828

Christelle Ansaldi, MD

cansaldi@genosciencepharma.com

2020-11-20

Unknown

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - 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.

2

Genoscience Pharma

18

100

France

Moderate disease at enrollment

3: Moderate disease at enrollment

178

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

None

Phase 2

[{"arm_notes": "", "treatment_id": 549, "treatment_name": "Gns561", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]