Metabolic Cofactor Supplementation and Hydroxychloroquine Combination in Covid-19 Patients

February 5, 2025 updated by: ScandiBio Therapeutics AB

A Multi Centre, Randomised, Controlled, Open-Label Phase 2/3 Study to Evaluate the Efficacy, Tolerability and Safety of Metabolic Cofactor Supplementation and Hydroxychloroquine Combination in Covid-19 Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Coronaviruses are a large family of ribonucleic acid viruses that cause mild to moderate upper respiratory diseases in humans. There is an urgent need for COVID-19 therapeutics due to the S-shaped curve expansion of the infections, widespread pandemic status, and global burden. Given the similarities between SARS-CoV-2 and other coronaviruses, and its relative ease of sample acquisition and study, it has been widely accepted that drug repositioning is a promising approach to make available an effective, safety-assured treatment in a timely manner.

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 investigational drug products, the mixture of the four co-factors will be administered as a powder with strawberry aroma to be dissolved in 200 ml of preferably cold still drinking water and be consumed within 5 minutes.

This study is planned as a Phase II / III clinical drug research to be conducted in patients diagnosed with COVID-19. Patients will be ambulatory and after the diagnosis/confirmation of diagnosis, will be sent home with their treatment. However, patients may be hospitalised during this initial examination period due to deterioration in their physical health or due to any medical condition which was not present at admission.

The primary objective is to assess the clinical efficacy of the combination of metabolic cofactors supplementation and hydroxychloroquine in COVID-19 patients. For the primary purpose, the proportion of patients who were hospitalised during the course of disease until 14 days after the initial diagnosis of Covid-19 disease will be compared. Patients who were hospitalised during the 14-day period, but at any time point after consenting will be evaluated as an end-point occurrence.

The secondary aim in this study is to evaluate the safety and tolerability of metabolic cofactors supplementation and hydroxychloroquine combination.

The initial part of the Phase II/III study is planned as a Phase II study which will enrol 100 patients and after an interim analysis it will conclude as a Phase III study (300 patients). Totally 400 COVID-19 disease patients will be randomized on a 3:1 basis to the combination metabolic cofactors supplementation and hydroxychloroquine or hydroxychloroquine+ placebo in eight clinical sites in Turkey.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Assoc. Prof. Levent DOĞANAY, MD
  • Phone Number: +90 505 525 04 91
  • Email: ldoganay@hotmail.com

Study Locations

  • Turkey
      • Istanbul, Turkey
        • University of Health Sciences Istanbul Ümraniye Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Arm
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
Treatment arm will include dietary supplement consisting of serine, L-carnitine tartrate, N-acetylcysteine and nicotinamide riboside + standard therapy (hydroxychloroquine).
Placebo Comparator: Placebo Arm
Subjects will take hydroxychloroquine (standard therapy) + dietary supplement placebo.
Drug: Hydroxychloroquine + Sorbitol
Placebo comparator will include sorbitol as placebo + standard therapy (hydroxychloroquine).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The evaluation of clinical efficacy of the combination of metabolic cofactor supplementation and hydroxychloroquine
Time Frame: 14 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in alanine aminotransferase (ALT) levels from baseline
Time Frame: 14 days
Clinical evaluation of ALT levels from baseline until the end of study.
14 days
Changes in aspartate aminotransferase (AST) levels from baseline
Time Frame: 14 days
Clinical evaluation of AST levels from baseline until the end of study.
14 days
Changes in C-reactive protein (CRP) levels from baseline
Time Frame: 14 days
Clinical evaluation of CRP levels from baseline until the end of study.
14 days
Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment
Time Frame: 14 days
Number/characteristics of Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment due to study drug from baseline until the end of study.
14 days
Chest Tomography
Time Frame: 1 day
Chest imaging will be documented at baseline visit.
1 day
ECG Measurement
Time Frame: 1 day
Change in heart rate will be measured at baseline visit.
1 day
Change of complete blood count from baseline
Time Frame: 14 days
Complete blood count includes number of blood cells and concentration of hemoglobin. Complete blood count will be performed to measure possible toxic effects of the metabolic cofactors supplementation and hydroxychloroquine combination on hematological system.
14 days
Changes in creatinine levels from baseline
Time Frame: 14 days
Clinical evaluation of creatinine levels from baseline until the end of study.
14 days
Changes in D-dimer levels from baseline
Time Frame: 14 days
Clinical evaluation of D-dimer levels from baseline until the end of study.
14 days
Changes in ferritin levels from baseline
Time Frame: 14 days
Clinical evaluation of ferritin levels from baseline until the end of study.
14 days
Changes in triglycerides levels from baseline
Time Frame: 14 days
Clinical evaluation of triglycerides levels from baseline until the end of study.
14 days
Changes in LDH levels from baseline
Time Frame: 14 days
Clinical evaluation of LDH levels from baseline until the end of study.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ScandiBio Therapeutics AB

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Kanuni Sultan Suleyman Training and Research Hospital
Bagcilar Training and Research Hospital
Istanbul Medipol University Hospital
Monitor CRO
Istanbul Umraniye Training and Research Hospital
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Alanya Alaaddin Keykubat University Alanya Training and Research Hospital
Canakkale 18 Mart University Health Research and Application Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Assoc. Prof. Levent DOĞANAY, MD, University of Health Sciences Istanbul Ümraniye Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COVID-19-MCS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Rare Diseases

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Dietary Supplements

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