A Study of Quintuple Therapy to Treat COVID-19 Infection

NCT04334512 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: PRG-044
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19; Corona Virus Infection; Coronavirus-19; Sars-CoV2

Outcome Measures

Primary Outcomes (7)

• The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy

  Number of days from COVID-19 diagnosis to recovery via RT-PCR

  12 weeks

• Reduction or Progression of Symptomatic Days

  Reduction and/or progression of symptomatic days, reduction of symptom severity

  12 weeks

• Assess the safety of Quintuple Therapy

  Assess the symptom response to study therapy as measured by the survey in the EDC

  12 weeks

• Assess the safety of Quintuple Therapy via pulse

  Pulse from baseline to 12 weeks

  12 weeks

• Assess the safety of Quintuple Therapy via oxygen saturation

  Oxygen saturation from baseline to 12 weeks

  12 weeks

• Assess the safety of Quintuple Therapy via EKG

  EKG response from baseline to 12 weeks

  12 weeks

• Assess Tolerability of Quintuple Therapy

  Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy

  12 weeks

Study Arms (2)

Quintuple Therapy

EXPERIMENTAL

Patients will be treated with quintuple therapy for 10 days.

Drug: Hydroxychloroquine; Drug: Azithromycin; Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin D; Dietary Supplement: Zinc

Placebo

PLACEBO COMPARATOR

Patients will be treated with placebo.

Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin D; Dietary Supplement: Zinc

Interventions

Hydroxychloroquine DRUG

Treatment with hydroxychloroquine

Also known as: Plaquenil

Quintuple Therapy

Azithromycin DRUG

Treatment with azithromycin

Also known as: Zithromax

Quintuple Therapy

Vitamin C DIETARY_SUPPLEMENT

Treatment with vitamin C

Placebo; Quintuple Therapy

Vitamin D DIETARY_SUPPLEMENT

Treatment with vitamin D

Placebo; Quintuple Therapy

Zinc DIETARY_SUPPLEMENT

Treatment with Zinc

Placebo; Quintuple Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• ProgenaBiome: lead
• DSCS CRO: collaborator

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

Related Publications (5)

• Banjanac M, Munic Kos V, Nujic K, Vrancic M, Belamaric D, Crnkovic S, Hlevnjak M, Erakovic Haber V. Anti-inflammatory mechanism of action of azithromycin in LPS-stimulated J774A.1 cells. Pharmacol Res. 2012 Oct;66(4):357-62. doi: 10.1016/j.phrs.2012.06.011. Epub 2012 Jul 3.

  PMID: 22766077 BACKGROUND

• Cortegiani A, Ingoglia G, Ippolito M, Giarratano A, Einav S. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020 Jun;57:279-283. doi: 10.1016/j.jcrc.2020.03.005. Epub 2020 Mar 10.

  PMID: 32173110 BACKGROUND

• Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19.

  PMID: 32074550 BACKGROUND

• Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.

  PMID: 32205204 BACKGROUND

• Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3.

  PMID: 32052466 BACKGROUND

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Hydroxychloroquine; Azithromycin; Ascorbic Acid; Vitamin D; Zinc

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Sabine Hazan, MD

  ProgenaBiome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a Randomized, Double-Blind, Placebo-Controlled Phase II interventional Study

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: June 22, 2020
• Primary Completion: February 27, 2024
• Study Completion: February 27, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)