Metabolic Cofactor Supplementation and Hydroxychloroquine Combination in Covid-19 Patients

NCT04573153 | Terminated Phase 2

• 1 other identifier: COVID-19-MCS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• The evaluation of clinical efficacy of the combination of metabolic cofactor supplementation and hydroxychloroquine

  The clinical efficacy will be evaluated by comparing the proportion of patients who were hospitalised during the course of disease until 14 days after the initial diagnosis of Covid-19.

  14 days

Secondary Outcomes (12)

• Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment

  14 days

• Chest Tomography

  1 day

• ECG Measurement

  1 day

• Change of complete blood count from baseline

  14 days

• Changes in alanine aminotransferase (ALT) levels from baseline

  14 days

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Subjects in ambulatory-at home-treatment will receive hydroxychloroquine (standard therapy) + dietary supplement consisting of serine, L-carnitine tartrate, N-acetylcysteine and nicotinamide riboside.

Drug: Hydroxychloroquine + Metabolic cofactor supplementation

Placebo Arm

PLACEBO COMPARATOR

Subjects will take hydroxychloroquine (standard therapy) + dietary supplement placebo.

Drug: Hydroxychloroquine + Sorbitol

Interventions

Hydroxychloroquine + Metabolic cofactor supplementation DRUG

Treatment arm will include dietary supplement consisting of serine, L-carnitine tartrate, N-acetylcysteine and nicotinamide riboside + standard therapy (hydroxychloroquine).

Treatment Arm

Hydroxychloroquine + Sorbitol DRUG

Placebo comparator will include sorbitol as placebo + standard therapy (hydroxychloroquine).

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ScandiBio Therapeutics AB: lead
• Istanbul Medipol University Hospital: collaborator
• Istanbul Umraniye Training and Research Hospital: collaborator
• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: collaborator
• Dr. Lutfi Kirdar Kartal Training and Research Hospital: collaborator
• Bagcilar Training and Research Hospital: collaborator
• Kanuni Sultan Suleyman Training and Research Hospital: collaborator
• Alanya Alaaddin Keykubat University Alanya Training and Research Hospital: collaborator
• Canakkale 18 Mart University Health Research and Application Hospital: collaborator
• Monitor CRO: collaborator

Study Sites (1)

University of Health Sciences Istanbul Ümraniye Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Sorbitol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Assoc. Prof. Levent DOĞANAY, MD

  University of Health Sciences Istanbul Ümraniye Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study was planned as a parallel group, randomized and open label study. The subjects will be randomized on a 3:1 basis to the cofactor supplementation combination plus hydroxychloroquine treatment or hydroxychloroquine +placebo treatment.

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 5, 2020
• Study Start: September 21, 2020
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: February 10, 2025

Record last verified: 2020-09

Locations

TU (1)