COVID-19Phase 2/3NCT04573153
Metabolic Cofactor Supplementation and Hydroxychloroquine Combination in Covid-19 Patients
A Phase 2/3 study testing Hydroxychloroquine + Metabolic cofactor supplementation and Hydroxychloroquine + Sorbitol in people with COVID-19, run by ScandiBio Therapeutics AB at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Hydroxychloroquine + Metabolic cofactor supplementation and Hydroxychloroquine + Sorbitol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Sep 2020to 5 May 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Istanbul Ümraniye Training and Research Hospital
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine + Metabolic cofactor supplementation, Hydroxychloroquine + Sorbitol
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine + Metabolic cofactor supplementationDrug
Treatment arm will include dietary supplement consisting of serine, L-carnitine tartrate, N-acetylcysteine and nicotinamide riboside + standard therapy (hydroxychloroquine).
Hydroxychloroquine + SorbitolDrug
Placebo comparator will include sorbitol as placebo + standard therapy (hydroxychloroquine).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Hydroxychloroquine + Metabolic cofactor supplementation |
| Placebo Arm | Placebo comparator | Subjects will take hydroxychloroquine (standard therapy) + dietary supplement placebo. Receives: Drug: Hydroxychloroquine + Sorbitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (12)
Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment
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.
Measured: 14 days
Chest Tomography
Chest imaging will be documented at baseline visit.
Measured: 1 day
ECG Measurement
Change in heart rate will be measured at baseline visit.
Measured: 1 day
Change of complete blood count from baseline
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.
Measured: 14 days
Changes in alanine aminotransferase (ALT) levels from baseline
Clinical evaluation of ALT levels from baseline until the end of study.
Measured: 14 days
Changes in aspartate aminotransferase (AST) levels from baseline
Clinical evaluation of AST levels from baseline until the end of study.
Measured: 14 days
Changes in C-reactive protein (CRP) levels from baseline
Clinical evaluation of CRP levels from baseline until the end of study.
Measured: 14 days
Changes in creatinine levels from baseline
Clinical evaluation of creatinine levels from baseline until the end of study.
Measured: 14 days
Changes in D-dimer levels from baseline
Clinical evaluation of D-dimer levels from baseline until the end of study.
Measured: 14 days
Changes in ferritin levels from baseline
Clinical evaluation of ferritin levels from baseline until the end of study.
Measured: 14 days
Changes in triglycerides levels from baseline
Clinical evaluation of triglycerides levels from baseline until the end of study.
Measured: 14 days
Changes in LDH levels from baseline
Clinical evaluation of LDH levels from baseline until the end of study.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start21 Sep 2020
- Primary completion5 May 2022
- Study completion5 May 2022
Why it stopped: Planned enrollment was not fulfilled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ScandiBio Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Istanbul Medipol University Hospital, Umraniye Education and Research Hospital, Bakirkoy Dr. Sadi Konuk Research and Training Hospital, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Bagcilar Training and Research Hospital, Kanuni Sultan Suleyman Training and Research Hospital, Alanya Alaaddin Keykubat University Alanya Training and Research Hospital, Canakkale 18 Mart University Health Research and Application Hospital, Monitor CRO
- Responsible party
- Sponsor
- Investigators
- Assoc. Prof. Levent DOĞANAY, MD, Principal investigator, University of Health Sciences Istanbul Ümraniye Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573153
- Sponsor's protocol ID
- COVID-19-MCS
- Status last verified
- Sep 2020
- First submitted
- 30 Sep 2020
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04573153
- Acronym / sponsor ID
- COVID-19-MCS
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Planned enrollment was not fulfilled.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ScandiBio Therapeutics ABIndustry (pharma, biotech, devices)
- Collaborators
- Istanbul Medipol University Hospital, Umraniye Education and Research Hospital, Bakirkoy Dr. Sadi Konuk Research and Training Hospital, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Bagcilar Training and Research Hospital, Kanuni Sultan Suleyman Training and Research Hospital, Alanya Alaaddin Keykubat University Alanya Training and Research Hospital, Canakkale 18 Mart University Health Research and Application Hospital, Monitor CRO
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Hydroxychloroquine + Metabolic cofactor supplementationSubjects in ambulatory-at home-treatment will receive hydroxychloroquine (standard therapy) + dietary supplement consisting of serine, L-carnitine tartrate, N-acetylcysteine and nicotinamide riboside. |
| Placebo Arm | Placebo comparator | Drug: Hydroxychloroquine + SorbitolSubjects will take hydroxychloroquine (standard therapy) + dietary supplement placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine + Metabolic cofactor supplementationTreatment arm will include dietary supplement consisting of serine, L-carnitine tartrate, N-acetylcysteine and nicotinamide riboside + standard therapy (hydroxychloroquine). | Drug | Treatment Arm |
| Hydroxychloroquine + SorbitolPlacebo comparator will include sorbitol as placebo + standard therapy (hydroxychloroquine). | Drug | Placebo Arm |
Primary outcome
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.
12 secondary outcomes
Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment
Time frame: 14 days
Chest Tomography
Time frame: 1 day
ECG Measurement
Time frame: 1 day
Change of complete blood count from baseline
Time frame: 14 days
Changes in alanine aminotransferase (ALT) levels from baseline
Time frame: 14 days
Changes in aspartate aminotransferase (AST) levels from baseline
Time frame: 14 days
Changes in C-reactive protein (CRP) levels from baseline
Time frame: 14 days
Changes in creatinine levels from baseline
Time frame: 14 days
Changes in D-dimer levels from baseline
Time frame: 14 days
Changes in ferritin levels from baseline
Time frame: 14 days
Changes in triglycerides levels from baseline
Time frame: 14 days
Changes in LDH levels from baseline
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Planned enrollment was not fulfilled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assoc. Prof. Levent DOĞANAY, MD principal investigator
University of Health Sciences Istanbul Ümraniye Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hydroxychloroquine + Metabolic cofactor supplementation and Hydroxychloroquine + Sorbitol in people with COVID-19, run by ScandiBio Therapeutics AB at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Planned enrollment was not fulfilled.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evaluation of clinical efficacy of the combination of metabolic cofactor supplementation and hydroxychloroquine (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.