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Metabolic Cofactor Supplementation and Hydroxychloroquine Combination in Covid-19 Patients

NCT04573153 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-02-10

No results posted yet for this study

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

Interventions

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).

DRUG

Hydroxychloroquine + Sorbitol

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

Sponsors & Collaborators

  • Istanbul Medipol University Hospital

    collaborator OTHER

  • Istanbul Umraniye Training and Research Hospital

    collaborator UNKNOWN

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    collaborator OTHER_GOV

  • Dr. Lutfi Kirdar Kartal Training and Research Hospital

    collaborator OTHER_GOV

  • Bagcilar Training and Research Hospital

    collaborator OTHER_GOV

  • Kanuni Sultan Suleyman Training and Research Hospital

    collaborator OTHER

  • Alanya Alaaddin Keykubat University Alanya Training and Research Hospital

    collaborator UNKNOWN

  • Canakkale 18 Mart University Health Research and Application Hospital

    collaborator UNKNOWN

  • Monitor CRO

    collaborator INDUSTRY

  • ScandiBio Therapeutics AB

    lead INDUSTRY

Principal Investigators

  • Assoc. Prof. Levent DOĞANAY, MD · University of Health Sciences Istanbul Ümraniye Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2022-05-05
Completion
2022-05-05

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04573153 on ClinicalTrials.gov