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.

Genoscience Pharma0 sites120 target enrollmentAugust 18, 2021

ConditionsCOVID-19 infection MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: COVID-19 infection
Sponsor: Genoscience Pharma
Enrollment: 120
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 18, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Genoscience Pharma

Eligibility Criteria

Inclusion Criteria

•1\. Age 18 or older at the time of enrolment.
•2\. Documented diagnosis of COVID\-19 (diagnostic test performed in a certified laboratory) which is preferable. However if limited access to the test, symptoms of COVID\-19 associated with lung imaging findings” on chest CT scan: unilateral or bilateral ground\-glass opacities and/or consolidation.
•3\. Clinical status: News2 score from 5 to 6\.
•4\. Adequate bone marrow and end\-organ function defined by the following laboratory results:
•Bone marrow:
•\- Hemoglobin \= 7\.0 g/dL,
•\- Absolute Neutrophils Count (ANC) \= 1\.0 Gi/L,
•\- Platelets \= 100 Gi/L;
•Hepatic function:
•\- Total serum bilirubin \= 1\.5 x ULN (except patients with Gilbert’s syndrome who must have total serum bilirubin \= 3\.0 x ULN),

Exclusion Criteria

•1\. Patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (quinine, chloroquine, tafenoquine, hydroxychloroquine, mefloquine).
•2\. Patient requires the use of one of the following forbidden treatment during the study treatment period:
•Major surgery.
•Live vaccines. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (Flu\-Mist®) are live attenuated vaccines, and are not allowed.
•3\. Any clinically significant cardiovascular condition as judged by the Investigator, like uncontrolled blood pressure, unstable angina, history of myocardial infraction within 6 months, clinically significant peripheral vascular disease
•4\. Known hepatitis B, treated or not, with viral load \< 20 UI/mL or Human Immunodeficiency Virus (HIV) infection, with negative viral load and CD4 \> 250/mm3, in last 3 months.
•5\. Prior allogeneic bone marrow transplantation or solid organ transplant in the past.
•6\. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
•7\. 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.