Metabolic Cofactor Supplementation and Hydroxychloroquine Combination in Covid-19 Patients

• Status: Recruiting
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This open label, randomized, controlled, investigator-initiated, multi-centre trial aims to establish metabolic improvements in COVID-19 subjects by dietary supplementation with cofactors N-acetylcysteine, L-carnitine tartrate, nicotinamide riboside and serine plus standard therapy. The primary objective is to assess the clinical efficacy of the combination of metabolic cofactors supplementation and hydroxychloroquine in COVID-19 patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ScandiBio Therapeutics AB
• Collaborators: Alanya Alaaddin Keykubat University Alanya Training and Research Hospital; Bagcilar Training and Research Hospital; Bakirkoy Dr. Sadi Konuk Research and Training Hospital; Canakkale 18 Mart University Health Research and Application Hospital; Dr. Lutfi Kirdar Kartal Training and Research Hospital; Istanbul Medipol University Hospital; Istanbul Umraniye Training and Research Hospital; Kanuni Sultan Suleyman Training and Research Hospital; Monitor CRO
• Treatments: Hydroxychloroquine; Sorbitol

Criteria

Inclusion Criteria:

• Patients of both genders (females and males) over 18 years of age

• Written informed consent obtained from the subjects prior to any procedures related to the study

• Understand all procedures to be applied within the scope of the study protocol

• Ambulatory patients with symptoms diagnosed with COVID-19 with Chest tomography (CT) result positivity in the last 72 hours

• Patients with stable clinical course and who could be treated on an ambulatory basis.

Exclusion Criteria:

• Patients who has partial oxygen saturation below 93% and require immediate hospitalisation after diagnosis

• Patients, upon initial examination, decided to be hospitalised at the intensive care-unit

• Inability or unwillingness to give written informed consent

• At physicians decision, the trial involvement will not be in patients' best interest, or any condition that does not allow the protocol to be followed safely

• Patients considered as inappropriate for this study for any reason

• Active participation in another clinical study

• Uncontrolled Type 1 or type 2 diabetes

• Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit)

• Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis

• Significant cardiovascular co-morbidity (i.e. heart failure)

• Patients with phenylketonuria (contraindicated for NAC)

• Known allergy for substances used in the study

• Pregnant or breastfeeding patients, or patients with positive pregnancy test in a pre-dose examination

• Receipt of any experimental treatment for COVID-19 within the 30 days prior to the time of the screening evaluation.