HAZDpaC: A Study of Quintuple Therapy to Treat COVID-19 Infection

Sponsor

ProgenaBiome (Other)

Overall Status

Recruiting

CT.gov ID

NCT04334512

Collaborator

DSCS CRO (Industry)

600

Enrollment

Location

Arms

50.3

Anticipated Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Corona Virus Infection Coronavirus-19 Sars-CoV2	Drug: Hydroxychloroquine Drug: Azithromycin Dietary Supplement: Vitamin C Dietary Supplement: Vitamin D Dietary Supplement: Zinc	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a Randomized, Double-Blind, Placebo-Controlled Phase II interventional StudyThis is a Randomized, Double-Blind, Placebo-Controlled Phase II interventional Study

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 22, 2020

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Quintuple Therapy Patients will be treated with quintuple therapy for 10 days.	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
Placebo Comparator: Placebo Patients will be treated with placebo.	Dietary Supplement: Vitamin C Treatment with vitamin C Dietary Supplement: Vitamin D Treatment with vitamin D Dietary Supplement: Zinc Treatment with Zinc

Arm

Intervention/Treatment

Experimental: Quintuple Therapy

Patients will be treated with quintuple therapy for 10 days.

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

Placebo Comparator: Placebo

Patients will be treated with placebo.

Dietary Supplement: Vitamin C

Treatment with vitamin C

Dietary Supplement: Vitamin D

Treatment with vitamin D

Dietary Supplement: Zinc

Treatment with Zinc

Outcome Measures

Primary Outcome Measures

The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy [12 weeks]
Number of days from COVID-19 diagnosis to recovery via RT-PCR
Reduction or Progression of Symptomatic Days [12 weeks]
Reduction and/or progression of symptomatic days, reduction of symptom severity
Assess the safety of Quintuple Therapy [12 weeks]
Assess the symptom response to study therapy as measured by the survey in the EDC
Assess the safety of Quintuple Therapy via pulse [12 weeks]
Pulse from baseline to 12 weeks
Assess the safety of Quintuple Therapy via oxygen saturation [12 weeks]
Oxygen saturation from baseline to 12 weeks
Assess the safety of Quintuple Therapy via EKG [12 weeks]
EKG response from baseline to 12 weeks
Assess Tolerability of Quintuple Therapy [12 weeks]
Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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