Trial | NCT04334512  Report issue

Title

A Study of Quintuple Therapy to Treat COVID-19 Infection
A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    600
This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).
In this study patients will be treated with a combination therapy to determine if this combination can effectively treat COVID-19. Treatment will last ten days. The study will last 24 weeks.
Study Started
Jun 22
2020
Primary Completion
Jun 30
2023
Anticipated
Study Completion
Sep 30
2024
Anticipated
Last Update
Sep 05
2021

Drug Hydroxychloroquine

Treatment with hydroxychloroquine

  • Other names: Plaquenil

Drug Azithromycin

Treatment with azithromycin

  • Other names: Zithromax

Dietary Supplement Vitamin C

Treatment with vitamin C

Dietary Supplement Vitamin D

Treatment with vitamin D

Dietary Supplement Zinc

Treatment with Zinc

Quintuple Therapy Experimental

Patients will be treated with quintuple therapy for 10 days.

Placebo Placebo Comparator

Patients will be treated with placebo.

Criteria 

Informed consent provided electronically via the EDC, demonstrating that the subject understands the procedures required for the study and the purpose of the study
Male or female subjects 18 years of age and up
Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study. This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. At least one of these must be a barrier method. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized)
Diagnosis of COVID-19 by RT-PCR

Exclusion Criteria

Refusal to provide informed consent
Diarrhea prior to infection
Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject

Any contraindications for treatment with hydroxychloroquine

Hypoglycemia
Known G6PD deficiency
Porphyria
Anemia
Neutropenia
Alcoholism
Myasthenia gravis
Skeletal muscle disorders
Maculopathy
Changes in visual field
Liver disease
Psoriasis
Anemia from pyruvate kinase and G6PD deficiencies
Abnormal EKG with QT prolongation acquired or from birth
Allergies to 4-Aminoquinolines
History of jaundice or high fevers prior to developing COVID-19
Treatment with any of the medications listed in Appendix II
Treatment with any other drug not listed that affects the QT interval
Treatment with any anti-epileptic drug, whether prescribed for seizures or otherwise.
Pregnant or breastfeeding women
No Results Posted